Beiträge von heiker

  • An Hr. Dr. K.

    Re: An Hr. Dr. K.

    Lieber Dr. K.

    zu dem "Unsinn" hier ein kurzer zusammenfassender Ausschnitt aus einem Gutachten eines ehemaligen FDA officers John L. Gueriguian, M.D. . Der Wirkmechanismus ist für alle GnRH gleich:

    Hier nun der Ausschnitt:

    LUPRON HEALTH PROBLEMS
    A THEMATIC REPORT
    John L. Gueriguian, M.D.
    Lupron affects the autonomic nervous system. Lupron not only affects the gonadal hormones, but is also a powerful modulator of autonomic neural function. The pituitary gland is the "master gland" and is helow the brain in the skull. The pituitary gland affects every physiological process of the body. In addition to the pituitary gland's endocrine functions, the pituitary gland may play a role in the immune response. Lupron suppresses the pituitary-gonadal system. Cancer drugs, such as Lupron, can be highly toxic

    Das gilt nicht nur für Lupron sondern alle GnRHs.
    Das ist bei Medizinern bekannt.
    Gruss
    heiker

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    Hallo STA,

    danke für Deine ehrliche Antwort.

    Auch dass Du schreibst, meine Quellen nicht gelesen zu haben. Verstehe ich absolut, denn wenn man keine Downregulierung plant, warum sollte man sich dafür dann interessieren?

    Mir wurde hier von Dr. K. vorgeworfen, dass ich "Gerüchte" über schwere Nebenwirkungen von GnRHs in die Welt gesetzt hätte. Es ist doch wohl eher umgekehrt, dass ich hier angegriffen werden soll. Wenn sich irgendjemand mal die Mühe gemacht hätte, meine Quellenangaben zu überprüfen, hätte er gemerkt, dass bereits von vielen - auch von Behörden (z.B. EMA) - auf die Risiken hingewiesen worden ist.

    STA, Du hast den Nagel auf den Kopf getroffen: eine Diskussion ist nicht möglich, wenn sich die Teilnehmer nicht die Quellen anschauen. Das habe ich nun begriffen :)

    Den Beweis eines Zusammenhanges oder eben nicht - das kann nur der Hersteller. Wir als Patienten können keine Millionen EUR für Studien bezahlen oder diese selbst durchführen. Jedenfalls kann ich das nicht. Es wurde ja von den Herstellern ja noch nicht mal der genaue Wirkmechanismus offengelegt (Verschwinden von GnRH Rezeptoren).
    Für den Nachweis eines Zusammenhangs bedarf es ja grundsätzlich 1. einem zeitlichen Zusammenhang (Symptome treten unter unter nach der Einnahme auf), 2. dem Nachweis, dass solche Symptome bereits in der Literatur berichetet worden sind (wurden sie im Rahmen von Case Reports und Studien) und drittens, dass in Behördenquellen genügend exakt solche Nebenwirkungen häufig berichtet werden. Es gibt wie bereits gesagt weltweit tausende Nebenwirkungsberichte und einige Quellen dieser Art habe ich hier angegeben. Studienangaben helfen natürlich auch (siehe z.B. EMA, Dec. 2011). Das alles gibts z.B. für Schäden am autonomen Nervensystem, ZNS und Immunmodulation durch GnRH. Natürlich müssen beim Patienten differentialdiagnostisch andere Störungen ausgeschlossen werden (z.B.MS, ander entzündliche Erkrankungen des ZNS, Lupus etc.)


    Harmlose Medikamente wie z.B. Erkältung etc. stehen nicht unter der Einteilung "Neoplastisch und Immunmodulator". Ich habe auch beispielsweise nie von Neuropathien im Zusammenhang mit solchen Medikamenten gelesen.

    Nochmals danke, STA, das war ein sachlicher Beitrag welchen ich mir von vielen anderen hier gewünscht hätte.

    Hier noch eine Internetseite von Betroffenen, diesmal auf französisch.
    http://enantone-effets-secondaires.hautetfort.com/desinformation_medicale/

    Gruss
    heiker

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    Hallo STA, und Annette

    sorry ich muss hier mal einhaken, wie kommst Du darauf, dass die Zulassungsstelle für Pharmaprodukte in Frankfurt sitzt? Bonn ist besser, jedenfalls in diesem Fall. Oder sitzt iin Frankfurt eine Aussenstelle?

    @Annette: Ich hatte gehofft, dass die Leute hier mal selbst recherchieren über GnRHs. Naja, hatte ich gehofft aber nicht wirklich erwartet. War zuviel gehofft. :)

    Ciao
    Heiker

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    Hallo Juni11,

    es ist eine Lüge, dass ich hier in den letzten Wochen hier Teilnehmer unaufgefordert angeschrieben haben soll.

    Es sollen diejenigen mal den Mut haben, sich hier öffentlich zu melden, denen ich in den letzten 8! Wochen unaufgefordert geschrieben haben soll. Ohne dass ich diese Mail hier reinstelle, kann sich ja hier dann auch keiner melden, weil er den Inhalt der Mail von Chris/Claudia nicht kennt.

    Grüssle
    heiker

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    Ich habe gerade von Chris Post bekommen:
    Hallo Heiker,

    uns erreichen hier ständig Emails von Forumsmitgliedern, die sich belästigt von Deinen Emails fühlen und bitten uns Dir mitzuteilen, dass Du das bitte unterlassen solst.
    Wir möchten Dich auf diesen Weg bitten, Mitglieder mit privaten Emails nicht mehr anzuschreiben, da die keinerlei Kontakt zu Dir wünschen.

    Bitte halte DIch daran Danke
    Claudia und Chris

    Die letzten privaten Nachrichten, die ich selbst an Teilnehmer geschickt habe, bezogen sich auf August. Wieso man nach 8 Wochen sich darüber beschweren sollte, erscheint mir an den Haaren herbeibgezogen. Ich kann mich ja auch irren: dann bitte ich darum dass mir mitteilt wer sich vor 8 Wochen belästigt fühlte. Das liesse sich ja leicht nachvollziehen.

    Fakt ist, und das kann ich leicht beweisen, dass mich hier einige von euch angeschrieben haben (und nicht umgekehrt). Es erscheint mir nicht plausibel, dass mir jemand zunächst eine Frage stellt und sich dann von der Antwort belästigt fühlt.
    Fakt ist, dass ich von einigen angeschrieben worden bin und darauf geantwortet habe. Niemand hat mir zurückgeschrieben, dass er eine Antwort nicht gewollt hätte.

    Merkwürdigerweise ist gerade vor einigen Minuten versucht worden, meine hinterlegte private E-Mail zu knacken. Ob das mit der obigen Mail im Zusammenhang steht, kann ich natürlich nicht beweisen.

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    Ich wollte euch über die Riskien der GnRHs informieren, die nicht im Beipackzettel stehen. Das war der Sinn und Zweck meiner Beträge.
    Nie habe ich behauptet, dass z.B. bei einem hormonellen Krebs diese Medikamente nicht angezeigt sind. Dann sind sie wahrscheinlich sehr sinnvoll, das kann ich nicht beurteilen. GrRHs waren zunächst nur für Krebs im Einsatz. Krebsmedikamente sind hoch toxisch. Nicht umsonst steht auf dem Beipackzettel, dass eine Schwangerschaft z.B. ausgeschlossen sein muss. Bei manchen steht sogar, dass Frauen, die schwanger werden sollten, diese nicht nehmen sollen.
    Warum man das dann für eine Eizellspende, die zu einer Schwangerschaft führen soll, nehmen sollte, hat mir hier noch keiner erklärt.

    Dies war mein letzter Beitrag hier öffentlich zu dem Thema. Ihr könnt mich gern weiter per pn anschreiben.

    Gruss
    heiker

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    @ alle

    Hier noch die von Dr. K angsprochene Marke: Lupron (auch Lycrin) Leuprorelin Acetate:

    Das Nebenwirkungsprofil ist leider auch nicht viel besser.

    Wenn mehrere Medikamente genommen wurden, steht jeweils da, ob noch andere "suspected" werden.

    Gruss
    heiker


    Results
    Number of reports (cases): 113
    (Multiple adverse events have been reported for some patients)
    Number of cases with a single suspected medicine: 89
    (The TGA thinks there is a possibility that the medicine caused the adverse event)
    Number of cases where death was a reported outcome: 3
    (These reports of death may or may not have been a result of taking a medicine)
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00052325 24/05/1988 - M Doloxene (Dextropropoxyphene
    Napsylate) - Suspected
    •
    Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    • Not specified (Flutamide) - Suspected
    Not specified (Warfarin Sodium) -
    Suspected
    •
    Coombs positive
    haemolytic
    anaemia
    •
    AU00089705 07/12/1993 - F Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Human Menopausal
    Gonadotrophin) - Suspected
    •
    Injection site
    reaction
    •
    AU00089706 07/12/1993 - F Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Human Menopausal
    Gonadotrophin) - Suspected
    •
    Injection site
    reaction
    •
    AU00089707 07/12/1993 - F Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Human Menopausal
    Gonadotrophin) - Suspected
    •
    Injection site
    reaction
    •
    AU00092375 26/04/1994 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • Anaphylactoid
    reaction
    •
    AU00092448 27/04/1994 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Urticaria
    AU00093677 08/06/1994 - F Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    • Metrodin (Urofollitrophin) - Suspected
    • Dizziness
    • Malaise
    • Nausea
    Rash maculopapular
    •
    AU00096668 25/10/1994 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    • Eulexin (Flutamide) - Not suspected
    • Face oedema
    • Pruritus
    Report generated leer12:12:55 AM Page 3 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00099062 21/02/1995 62 M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Cogentin (Benztropine Mesylate) - Not
    suspected
    •
    Neulactil (Pericyazine) - Not
    suspected
    •
    Not specified (Lithium Carbonate) -
    Not suspected
    •
    Not specified (Oxazepam) - Not
    suspected
    •
    Psychotic
    disorder
    •
    AU00104211 27/10/1995 - - Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Androcur (Cyproterone Acetate) - Not
    suspected
    •
    Not specified (Morphine Nos) - Not
    suspected
    •
    • Sorbilax (Sorbitol) - Not suspected
    • Cardiac arrest
    AU00105860 15/01/1996 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Asthenia
    Injection site
    pain
    •
    AU00106938 07/03/1996 - F Lucrin (Leuprorelin Acetate) -
    Suspected
    • Injection site
    inflammation
    •
    Injection site
    pain
    •
    AU00107941 17/04/1996 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Fixed eruption
    Genital
    ulceration
    •
    AU00109290 17/06/1996 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    • Not specified (Flutamide) - Suspected
    • Oruvail SR (Ketoprofen) - Suspected
    • Cataract
    AU00112696 31/10/1996 - F Lucrin (Leuprorelin Acetate) -
    Suspected
    • Grand mal
    convulsion
    •
    • Hypercalcaemia
    Hyperproteinae
    mia
    •
    AU00113120 13/11/1996 - - • Aprinox (Bendrofluazide) - Suspected
    • Coversyl (Perindopril) - Suspected
    Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    • Not specified (Flutamide) - Suspected
    Anaemia
    macrocytic
    •
    Report generated leer12:12:55 AM Page 4 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00116854 18/04/1997 - - Lucrin (Leuprorelin Acetate) -
    Suspected
    • Rash maculopapular
    •
    • Skin exfoliation
    AU00118231 12/06/1997 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Arthralgia
    • Myalgia
    • Osteoarthritis
    AU00121225 30/09/1997 35 F Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Hyperhidrosis
    • Nausea
    • Tremor
    AU00121371 06/10/1997 - F Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    • Metrodin (Urofollitrophin) - Suspected
    • Naprosyn (Naproxen) - Not suspected
    Panadol (Paracetamol) - Not
    suspected
    •
    • Arthralgia
    • Bone pain
    • Dysphagia
    AU00121934 27/10/1997 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Arthritis
    • Back pain
    AU00125806 17/03/1998 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Hypercalcaemia
    AU00128002 01/06/1998 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    • Tazac (Nizatidine) - Suspected
    • Anaemia
    AU00128366 12/06/1998 86 M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    Anginine (Glyceryl Trinitrate) - Not
    suspected
    •
    Cardizem (Diltiazem Hydrochloride) -
    Not suspected
    •
    Not specified (Enalapril Maleate) - Not
    suspected
    •
    Not specified (Frusemide) - Not
    suspected
    •
    Not specified (Glyceryl Trinitrate) - Not
    suspected
    •
    Not specified (Nizatidine) - Not
    suspected
    •
    Not specified (Prazosin Hydrochloride)
    - Not suspected
    •
    • Anaemia
    Report generated leer12:12:55 AM Page 5 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00140694 18/06/1999 79 M Honvan (Fosfestrol Tetrasodium) -
    Suspected
    •
    Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    • Cardiac failure
    Pulmonary
    embolism
    •
    AU00140719 21/06/1999 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Injection site
    pain
    •
    • Myalgia
    AU00140879 21/06/1999 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Injection site
    pain
    •
    • Myalgia
    AU00145186 29/10/1999 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Left ventricular
    failure
    •
    AU00145187 29/10/1999 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Extrasystoles
    AU00145188 29/10/1999 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Cardiomyopathy
    AU00153160 29/05/2000 - M Aredia (Disodium Pamidronate) -
    Suspected
    •
    Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Morphine Sulphate) -
    Suspected
    •
    • Nausea
    AU00154293 28/06/2000 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Hot flush
    AU00156276 14/08/2000 - M • Eulexin (Flutamide) - Suspected
    Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    • Anaemia
    • Fatigue
    • Herpes zoster
    AU00158267 05/10/2000 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Injection site
    reaction
    •
    AU00158288 05/10/2000 78 M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Neuropathy
    peripheral
    •
    AU00158952 30/10/2000 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Gynaecomastia
    AU00168895 02/10/2001 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Panadeine Forte (Paracetamolcodeine
    Phosphate) - Not suspected
    •
    • Vioxx (Rofecoxib) - Not suspected
    • Abscess
    Report generated leer12:12:55 AM Page 6 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00175258 08/05/2002 - F • Gonal-f (Follitropin Alfa) - Suspected
    Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Synarel (Nafarelin Acetate) -
    Suspected
    •
    Erythema
    multiforme
    •
    AU00176841 04/07/2002 71 M Androcur (Cyproterone Acetate) -
    Suspected
    •
    Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    • Hepatitis
    AU00182882 14/02/2003 - - Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    • Noten (Atenolol) - Not suspected
    Seretide Accuhaler Nos (Fluticasone
    Propionate-salmeterol Xinafoate) - Not
    suspected
    •
    • Dyspnoea
    AU00183142 21/02/2003 - - Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Colchicine) - Not
    suspected
    •
    • Arthritis
    AU00185371 28/04/2003 73 M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Asasantin SR) - Not
    suspected
    •
    • Zocor (Simvastatin) - Not suspected
    Injection site
    reaction
    •
    • Tenderness
    AU00190070 01/09/2003 77 M Androcur (Cyproterone Acetate) -
    Suspected
    •
    Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    • Hepatitis acute
    AU00191334 16/10/2003 70 M • Cosudex (Bicalutamide) - Suspected
    Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    • Cardiac failure
    • Fluid retention
    AU00195493 16/03/2004 68 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • Injection site
    pain
    •
    AU00198633 01/07/2004 75 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Infection
    AU00204377 21/01/2005 70 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Eczema
    • Rash
    Type IV
    hypersensitivity
    reaction
    •
    • Urticaria
    Report generated leer12:12:55 AM Page 7 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00205630 28/02/2005 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Purpura
    AU00207613 05/05/2005 72 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Angina unstable
    Aortic valve
    disease
    •
    Cerebrovascular
    accident
    •
    • Dilatation atrial
    Mitral valve
    incompetence
    •
    Pulmonary
    hypertension
    •
    AU00207616 05/05/2005 67 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Cholecystitis
    AU00212625 17/10/2005 66 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • Neuropathy
    peripheral
    •
    AU00212773 24/10/2005 - M • Cosudex (Bicalutamide) - Suspected
    Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    • Neutropenia
    AU00215098 19/01/2006 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Efexor-XR (Venlafaxine
    Hydrochloride) - Not suspected
    •
    • Dysuria
    • Insomnia
    • Suicidal ideation
    AU00215512 02/02/2006 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Hypersensitivity
    Rash maculopapular
    •
    • Urticaria
    AU00215608 07/02/2006 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Zoledronic Acid) -
    Suspected
    •
    • Chest pain
    • Pyrexia
    AU00215610 07/02/2006 62 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • Obstructive
    uropathy
    •
    • Renal pain
    AU00217293 11/04/2006 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Vision blurred
    Visual
    impairment
    •
    AU00217813 01/05/2006 57 M Lucrin (Leuprorelin Acetate) -
    Suspected
    • Injection site
    swelling
    •
    Report generated leer12:12:55 AM Page 8 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00218382 16/05/2006 77 M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Zoledronic Acid) -
    Suspected
    •
    • Not specified (Aspirin) - Not suspected
    Not specified (Celecoxib) - Not
    suspected
    •
    Not specified (Salbutamol) - Not
    suspected
    •
    • Ascites
    Bacterial
    infection
    •
    • Biliary sepsis
    • Cholelithiasis
    Hepatic
    encephalopathy
    •
    • Hepatic mass
    • Jaundice
    • Pyrexia
    Respiratory
    failure
    •
    Sinus
    tachycardia
    •
    AU00218394 16/05/2006 74 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • Cerebrovascular
    accident
    •
    AU00218991 06/06/2006 62 - Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Zoledronic Acid) - Not
    suspected
    •
    • Carbuncle
    • Furuncle
    Injection site
    reaction
    •
    Subcutaneous
    abscess
    •
    AU00219099 13/06/2006 74 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Amnesia
    • Asthenia
    Cerebrovascular
    accident
    •
    AU00219930 12/07/2006 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • Injection site
    reaction
    •
    AU00219965 12/07/2006 73 M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Zoledronic Acid) - Not
    suspected
    •
    • Chest pain
    AU00222271 09/10/2006 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    • Cartia (Aspirin) - Not suspected
    Catapres (Clonidine Hydrochloride) -
    Not suspected
    •
    • Lipitor (Atorvastatin) - Not suspected
    Nexium (Esomeprazole Magnesium
    Trihydrate) - Not suspected
    •
    Zoloft (Sertraline Hydrochloride) - Not
    suspected
    •
    • Chest pain
    • Dyspnoea
    • Fatigue
    • Muscle spasms
    Report generated leer12:12:55 AM Page 9 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00223114 14/11/2006 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Lower
    respiratory tract
    infection
    •
    AU00225670 12/02/2007 67 M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Obstructive
    uropathy
    •
    Renal failure
    acute
    •
    Urinary tract
    infection
    •
    AU00225828 14/02/2007 63 M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Dizziness
    • Feeling hot
    • Hyperhidrosis
    • Vision blurred
    AU00229103 30/05/2007 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Injection site
    haematoma
    •
    Injection site
    necrosis
    •
    AU00229888 19/06/2007 87 M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Depression
    Erectile
    dysfunction
    •
    • Fatigue
    Memory
    impairment
    •
    • Meningitis
    • Pollakiuria
    Urinary
    incontinence
    •
    AU00231723 09/08/2007 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Injection site
    haematoma
    •
    Injection site
    mass
    •
    Injection site
    necrosis
    •
    • Muscle abscess
    • Muscle necrosis
    AU00232217 20/08/2007 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Flutamide) - Not
    suspected
    •
    Anaphylactic
    reaction
    •
    Report generated leer12:12:55 AM Page 10 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00234069 05/10/2007 69 M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Budesonide) - Not
    suspected
    •
    Not specified (Meloxicam) - Not
    suspected
    •
    Not specified (Perindopril) - Not
    suspected
    •
    Not specified (Salbutamol) - Not
    suspected
    •
    Not specified (Thioridazine
    Hydrochloride) - Not suspected
    •
    Not specified (Tiotropium) - Not
    suspected
    •
    Acute
    myocardial
    infarction
    •
    Pulmonary
    oedema
    •
    AU00234961 01/11/2007 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Drug ineffective
    AU00235417 19/11/2007 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Injection site
    pustule
    •
    Injection site
    reaction
    •
    AU00239411 31/03/2008 76 M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Allopurinol) - Not
    suspected
    •
    • Not specified (Aspirin) - Not suspected
    Microcytic
    anaemia
    •
    AU00240017 15/04/2008 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Pain
    AU00243126 22/07/2008 75 M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Acetic Acid) - Not
    suspected
    •
    Not specified (Aminoglutethimide) -
    Not suspected
    •
    Not specified (Amlodipine) - Not
    suspected
    •
    Not specified (Cortisone) - Not
    suspected
    •
    Not specified (Perindopril) - Not
    suspected
    •
    Not specified (Zoledronic Acid) - Not
    suspected
    •
    Acute coronary
    syndrome
    •
    Acute
    myocardial
    infarction
    •
    Report generated leer12:12:55 AM Page 11 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00243450 04/08/2008 - F Lucrin (Leuprorelin Acetate) -
    Suspected
    • Injection site
    reaction
    •
    AU00243583 07/08/2008 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Incorrect route of
    drug
    administration
    •
    AU00243792 13/08/2008 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Abscess
    • Haematoma
    AU00245292 09/10/2008 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Sciatica
    AU00245710 21/10/2008 72 M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Cyproterone Acetate) -
    Suspected
    •
    • Jaundice
    AU00249538 23/03/2009 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Arrhythmia
    Rash
    generalised
    •
    AU00251093 18/05/2009 - F Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Chorionic
    Gonadotrophin) - Not suspected
    •
    Not specified (Follitropin Alfa) - Not
    suspected
    •
    Not specified (Somatropin) - Not
    suspected
    •
    • Pneumonia
    AU00252013 09/06/2009 - F Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Hypersensitivity
    • Skin ulcer
    AU00253674 13/07/2009 6 F Lucrin (Leuprorelin Acetate) -
    Suspected
    • Injection site
    reaction
    •
    AU00254089 19/07/2009 33 F Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Gonal-f (Follitropin Alfa) - Not
    suspected
    •
    Not specified (Folic Acid) - Not
    suspected
    •
    • Muscle twitching
    Muscular
    weakness
    •
    • Myalgia
    • Oedema
    Report generated leer12:12:55 AM Page 12 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00254703 30/07/2009 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Dysuria
    Emotional
    distress
    •
    • Eye pain
    • Eyelid disorder
    • Gait disturbance
    • Haematochezia
    Impaired driving
    ability
    •
    Injection site
    pain
    •
    • Insomnia
    • Paraesthesia
    • Scrotal pain
    Visual
    impairment
    •
    AU00255140 08/08/2009 68 F Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Myocardial
    infarction
    •
    AU00261562 05/01/2010 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Drug ineffective
    Histology
    abnormal
    •
    AU00265916 28/04/2010 77 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • Anaphylactic
    reaction
    •
    AU00267113 12/05/2010 - M Fluvax (Influenza Vaccine) -
    Suspected
    •
    Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    Guillain-Barre
    syndrome
    •
    AU00275415 10/11/2010 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • Loss of
    consciousness
    •
    AU00275772 19/11/2010 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • Injection site
    pain
    •
    Injection site
    swelling
    •
    AU00275944 24/11/2010 83 M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Lisinopril) - Not
    suspected
    •
    Not specified (Moxonidine) - Not
    suspected
    •
    Blood pressure
    increased
    •
    Micturition
    urgency
    •
    Report generated leer12:12:55 AM Page 13 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00280867 05/04/2011 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Deep vein
    thrombosis
    •
    Lung neoplasm
    malignant
    •
    Metastases to
    bone
    •
    Metastatic
    squamous cell
    carcinoma
    •
    • Pleural effusion
    • Pulmonary mass
    AU00281100 08/04/2011 60 M Lucrin (Leuprorelin Acetate) -
    Suspected
    • Application site
    reaction
    •
    • Cold sweat
    • Dizziness
    • Fatigue
    • Vomiting
    AU00284775 21/06/2011 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Warfarin Sodium) -
    Suspected
    •
    International
    normalised ratio
    increased
    •
    AU00284836 22/06/2011 75 - Lucrin (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Zoledronic Acid) -
    Suspected
    •
    Cortate (Cortisone Acetate) - Not
    suspected
    •
    • Coversyl (Perindopril) - Not suspected
    Nexium (Esomeprazole Magnesium
    Trihydrate) - Not suspected
    •
    • Norvasc (Amlodipine) - Not suspected
    Not specified (Clopidogrel) - Not
    suspected
    •
    Not specified (Ketoconazole) - Not
    suspected
    •
    Acute coronary
    syndrome
    •
    Acute
    myocardial
    infarction
    •
    Arteriosclerosis
    coronary artery
    •
    Coronary artery
    stenosis
    •
    Myocardial
    ischaemia
    •
    Respiratory tract
    infection
    •
    Troponin
    increased
    •
    AU00286898 03/08/2011 67 M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • • Headache
    • Hypertension
    AU00287149 09/08/2011 73 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Abdominal pain
    Activities of daily
    living impaired
    •
    • Hiatus hernia
    Report generated leer12:12:55 AM Page 14 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00287150 09/08/2011 72 - Lucrin (Leuprorelin Acetate) -
    Suspected
    • Diabetes
    mellitus
    •
    AU00288101 30/08/2011 - - Lucrin (Leuprorelin Acetate) -
    Suspected
    • Diabetes
    mellitus
    •
    • Pain of skin
    • Rash
    AU00289537 26/09/2011 - - Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Cardiac failure
    AU00289933 05/10/2011 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Bicalutamide) - Not
    suspected
    •
    • Arthropathy
    • Asthma
    • Back pain
    • Bone pain
    • Bronchitis
    • Cough
    Disturbance in
    attention
    •
    • Headache
    • Hot flush
    • Lethargy
    • Osteoporosis
    • Pain
    Prostate cancer
    metastatic
    •
    Prostatic specific
    antigen
    increased
    •
    AU00291000 26/10/2011 59 - Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Burning
    sensation
    •
    Neuropathy
    peripheral
    •
    • Pain in extremity
    • Paraesthesia
    AU00294117 03/01/2012 77 - Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Injection site
    pain
    •
    • Skin cancer
    AU00298093 28/03/2012 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Tooth disorder
    • Tooth fracture
    Report generated leer12:12:55 AM Page 15 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Footnotes
    i A unique number that permits reference to a particular case
    ii The date that information from the original report was entered into the database
    iii Age of patient at time of adverse event, '-' if unknown
    iv Gender of patient, '-' if unknown
    v Medicines reported to have been taken by the patient
    vi A description of the adverse event as defined by the Medical Dictionary for Regulatory Activities (MedDRA). You can
    use the MedlinePlus medical dictionary <http://www.nlm.nih.gov/medlineplus/mplusdictionary.html> to look up terms.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00298973 16/04/2012 79 M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    •
    Not specified (Acetylsalicylic Acid CT)
    - Not suspected
    •
    Not specified (Allopurinol) - Not
    suspected
    •
    Not specified (Atenolol) - Not
    suspected
    •
    Not specified (Gliclazide) - Not
    suspected
    •
    Not specified (Magnesium Nos) - Not
    suspected
    •
    Not specified (Metformin
    Hydrochloride) - Not suspected
    •
    Not specified (Perindopril) - Not
    suspected
    •
    Confusional
    state
    •
    Injection site
    induration
    •
    Injection site
    pain
    •
    Injection site
    swelling
    •
    • Lethargy
    • Pain
    • Pyrexia
    AU00301119 28/05/2012 - M Lucrin (Leuprorelin Acetate) -
    Suspected
    • Myocardial
    infarction
    •
    AU00301348 31/05/2012 86 M Lucrin (Leuprorelin Acetate) -
    Suspected
    • • Pain
    AU00301615 05/06/2012 - M Lucrin Depot (Leuprorelin Acetate) -
    Suspected
    • Myeloid
    leukaemia in
    remission
    •
    Report generated leer12:12:55 AM Page 16 of 16
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    Liebe dfit,

    warum liesst Du meine Beiträge, wenn Sie Dich nerven? Das verstehe ich nicht.

    @Dr. K,

    in die Nebenwirkungsliste kommt ein Fall z.B. für Zoladex nur dann, wenn dieses Medikament unter Verdacht steht. Wenn es ein anderes gleichzeitig eingenommenes Medikament wäre, was unter Verdacht stehen würde, wäre es dort in der Liste enthalten. Und dann z.B. nicht bei Zoladex. Das steht auch auf der Seite der Behörde und ist international anerkanntes vorgehen.

    Was meinen Sie mit Langzeitbehandlung? Unter Langzeitbehandlung verstehe ich, wenn die Behandlung zum Stoppen der Ovulation führt.
    Einige lassen sich hier sogar mehrfach downregulieren und auch bei Endometriose z.B. wird nicht mehr als 6 x ein Depotpräparat geraten. Empfohlen wird es sowieso von vielen Ärzten nicht mehr bei Endo.

    Das Nebenwirkungsprofil der GNRHs (Zoladex, Lupron, Decapeptyl, Synarela etc.) ist in etwa identisch, das sagt mir zumindest meine "Rote Liste".

    Sie können den Krebs ja gern "abhaken". Die Betroffenen können das leider nicht.

    Gruss
    heiker

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    Lieber Herr K.
    nach welchen Medikamenten und Wirkstoffen habe Sie gesucht? Z.B. bei Zoladex, 3.75 mg findet man 2 Knochenmetastasen und 1 Throat Cancer. Daneben Nierenversagen, Herzinfarkte, Schilddrüsenprobleme, Tremor, Muskelzuckeungen, Neuropathien, Migräne; Depressionen, Schwächegefühl, Schmerzen, etc....es ist irgendwie alles dabei.

    Bei 190 Berichten gab es 49 Tote (wahrscheinlich aber alles ältere Männer, leider fehlen die Altersangaben oft.) Vielleicht wären die ohnehin an Prostatakarzinom gestorben, wer weiss das schon...

    Leute, schaut selbst, verlasst euch nicht auf irgendjemanden, auch nicht auf mich. Wie ihr sehen könnt, gibt es keinen 100%-igen Beweis. Den kann es auch nicht geben, in der Medizin arbeitet man immer mit Wahrscheinlichkeiten. Und ehrlich gesagt, über diese Wahrscheinlichkeiten möchte ich informiert werden!

    Die EMA hat im übrigen die Hersteller aufgefordert, über das erhöhte Risiko, nach GnRH an schweren Depression zu erkranken, zu informieren. Das war Dez. 2011.

    LG
    heiker


    Australische NW Berichte zu Zoladex (bitte selbst runterladen, ich weiss das ganze ist jetzt hier wie ich es einstellen kann, schlecht lesbar.:

    Results
    Number of reports (cases): 190
    (Multiple adverse events have been reported for some patients)
    Number of cases with a single suspected medicine: 149
    (The TGA thinks there is a possibility that the medicine caused the adverse event)
    Number of cases where death was a reported outcome: 49
    (These reports of death may or may not have been a result of taking a medicine)
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00059063 28/02/1989 28 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Drug ineffective
    Renal failure
    acute
    •
    AU00068990 17/12/1990 - M Androcur (Cyproterone Acetate) -
    Suspected
    •
    • Not specified (Thiamine) - Suspected
    • Pepcidine (Famotidine) - Suspected
    Stemetil (Prochlorperazine Maleate) -
    Suspected
    •
    • Ventolin (Salbutamol) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Chills
    • Convulsion
    • Headache
    AU00069598 15/02/1991 38 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Hot flush
    AU00073663 21/10/1991 64 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Blood alkaline
    phosphatase
    increased
    •
    • Gynaecomastia
    • Spider naevus
    AU00076915 11/05/1992 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Not specified (Flutamide) - Not
    suspected
    •
    • Bronchospasm
    • Cough
    • Rhinitis
    Report generated 8/10/2012 12:48:28 AM Page 3 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00082994 22/02/1993 - M Androcur (Cyproterone Acetate) -
    Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Amnesia
    • Ataxia
    Consciousness
    fluctuating
    •
    • Delirium
    • Dementia
    Disturbance in
    attention
    •
    Faecal
    incontinence
    •
    • Gait disturbance
    Urinary
    incontinence
    •
    AU00085507 24/06/1993 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Rash maculopapular
    •
    AU00090804 31/01/1994 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Diabetes
    mellitus
    •
    AU00091097 16/02/1994 - M • Not specified (Flutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Hepatic function
    abnormal
    •
    AU00094043 28/06/1994 - M • Eulexin (Flutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Haemolysis
    AU00094304 08/07/1994 - M • Daonil (Glibenclamide) - Suspected
    • Eulexin (Flutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Diabetes
    mellitus
    •
    • Hyperhidrosis
    • Pyrexia
    AU00095977 19/09/1994 35 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Uterine
    haemorrhage
    •
    AU00096045 26/09/1994 - - Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Weight
    increased
    •
    Report generated 8/10/2012 12:48:28 AM Page 4 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00096313 06/10/1994 - F • Coversyl (Perindopril) - Suspected
    Diabex (Metformin Hydrochloride) -
    Suspected
    •
    • F.G.F, (F.g.f.) - Suspected
    Isoptin (Verapamil Hydrochloride) -
    Suspected
    •
    • Lanoxin (Digoxin) - Suspected
    • Not specified (Frusemide) - Suspected
    Primolut-n (Norethisterone) -
    Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Prothrombin
    level increased
    •
    AU00097497 01/12/1994 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Renitec (Enalapril Maleate) - Not
    suspected
    •
    • Serepax (Oxazepam) - Not suspected
    Voltaren (Diclofenac Sodium) - Not
    suspected
    •
    Photosensitivity
    reaction
    •
    AU00097539 05/12/1994 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Fatigue
    • Myalgia
    AU00098032 29/12/1994 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Injection site
    necrosis
    •
    AU00098298 12/01/1995 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Alopecia
    AU00098742 06/02/1995 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Abdominal pain
    • Asthenia
    • Hot flush
    • Nausea
    • Syncope
    • Tremor
    • Vomiting
    AU00098920 13/02/1995 - F Not specified (Sandocal 1000) -
    Suspected
    •
    Premarin (Oestrogens Conjugated) -
    Suspected
    •
    Provera (Medroxyprogesterone
    Acetate) - Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Pathological
    fracture
    •
    Report generated 8/10/2012 12:48:28 AM Page 5 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00099262 28/02/1995 74 M • Not specified (Flutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Not specified (Calcium Carbonate) -
    Not suspected
    •
    Not specified (Ferrous Sulphate) - Not
    suspected
    •
    Not specified (Warfarin Sodium) - Not
    suspected
    •
    Vitamin B Group And C Injection
    (Vitamin Preparation Compound) - Not
    suspected
    •
    • Flatulence
    AU00099458 08/03/1995 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Pain
    AU00099477 15/03/1995 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Hypopituitarism
    AU00099810 27/03/1995 45 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Abdominal pain
    Vaginal
    haemorrhage
    •
    AU00101281 29/05/1995 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Hypercholesterol
    aemia
    •
    AU00101203 30/05/1995 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Depression
    Erectile
    dysfunction
    •
    • Hot flush
    • Insomnia
    Libido
    decreased
    •
    AU00101251 31/05/1995 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Alopecia
    AU00101835 30/06/1995 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Acne
    • Drug ineffective
    • Ovarian cyst
    Uterine
    haemorrhage
    •
    AU00102875 14/08/1995 29 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Ovarian
    hyperstimulation
    syndrome
    •
    Vaginal
    haemorrhage
    •
    Report generated 8/10/2012 12:48:28 AM Page 6 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00102943 17/08/1995 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Premarin (Oestrogens Conjugated) -
    Not suspected
    •
    Theo-dur (Theophylline) - Not
    suspected
    •
    • Ventolin (Salbutamol) - Not suspected
    • Optic neuritis
    Visual
    impairment
    •
    AU00103470 11/09/1995 83 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Pruritus
    • Rash
    AU00103632 20/09/1995 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Dizziness
    • Dysgeusia
    • Paraesthesia
    • Pruritus
    AU00104038 16/10/1995 70 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Rash
    AU00104808 23/11/1995 - M Cardizem (Diltiazem Hydrochloride) -
    Suspected
    •
    Imdur (Isosorbide Mononitrate) -
    Suspected
    •
    Nitradisc (Glyceryl Trinitrate) -
    Suspected
    •
    Not specified (Enalapril Maleate) -
    Suspected
    •
    • Not specified (Frangula) - Suspected
    Not specified (Senna Fruit) -
    Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Hepatic function
    abnormal
    •
    AU00104925 28/11/1995 - M Androcur (Cyproterone Acetate) -
    Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Hepatic failure
    AU00104942 28/11/1995 - M • Lasix (Frusemide) - Suspected
    Minipress (Prazosin Hydrochloride) -
    Suspected
    •
    Not specified (Amiodarone
    Hydrochloride) - Suspected
    •
    • Not specified (Flutamide) - Suspected
    Renitec (Enalapril Maleate) -
    Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Asthenia
    • Cough
    • Dyspnoea
    • Hypoaesthesia
    • Hypoxia
    • Pain
    Pulmonary
    fibrosis
    •
    Skin
    discolouration
    •
    Report generated 8/10/2012 12:48:28 AM Page 7 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00106581 21/02/1996 40 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Anxiety
    AU00107214 19/03/1996 24 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Becloforte (Beclomethasone
    Dipropionate) - Not suspected
    •
    Electroencephal
    ogram abnormal
    •
    • Sleep disorder
    Thinking
    abnormal
    •
    AU00107411 28/03/1996 35 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Arthralgia
    AU00110182 24/07/1996 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Injection site
    pain
    •
    AU00110649 08/08/1996 - M • Eulexin (Flutamide) - Suspected
    • Proscar (Finasteride) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Dyspnoea
    • Eosinophilia
    Eosinophilic
    pneumonia
    •
    AU00111514 09/09/1996 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Arthralgia
    • Constipation
    • Cough
    Decreased
    appetite
    •
    • Eosinophilia
    Eosinophilic
    pneumonia
    •
    • Fatigue
    • Myalgia
    Red blood cell
    sedimentation
    rate increased
    •
    Thrombocytopen
    ia
    •
    AU00111540 09/09/1996 - M • Eulexin (Flutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Arthralgia
    • Arthritis
    AU00112429 21/10/1996 - M • Eulexin (Flutamide) - Suspected
    • Not specified (Aspirin) - Suspected
    • Not specified (Perindopril) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Anaemia
    • Fatigue
    AU00112492 24/10/1996 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Aggression
    • Depression
    • Migraine
    Report generated 8/10/2012 12:48:28 AM Page 8 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00113196 15/11/1996 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Bronchospasm
    AU00114547 15/01/1997 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Unintended
    pregnancy
    •
    AU00115045 06/02/1997 - M • Eulexin (Flutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Dyspepsia
    • Malaise
    AU00115364 17/02/1997 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Hypertension
    AU00116236 21/03/1997 - M • Cosudex (Bicalutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Androcur (Cyproterone Acetate) - Not
    suspected
    •
    Lucrin (Leuprorelin Acetate) - Not
    suspected
    •
    • Norvasc (Amlodipine) - Not suspected
    • Oedema
    AU00117759 22/05/1997 - M Anginine (Glyceryl Trinitrate) -
    Suspected
    •
    Cardizem Cd (Diltiazem
    Hydrochloride) - Suspected
    •
    • Solprin (Aspirin Soluble) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Furuncle
    AU00120819 15/09/1997 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Injection site
    inflammation
    •
    AU00120940 18/09/1997 39 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Injection site
    inflammation
    •
    AU00121269 01/10/1997 62 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Hot flush
    AU00121907 27/10/1997 - M • Anandron (Nilutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Dyspnoea
    • Lung infiltration
    Respiratory
    failure
    •
    AU00122352 14/11/1997 - M Not specified (Bicalutamide) -
    Suspected
    •
    • Not specified (Flutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Diabetes
    mellitus
    •
    Report generated 8/10/2012 12:48:28 AM Page 9 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00122696 24/11/1997 21 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Galactorrhoea
    AU00124473 29/01/1998 - F Premarin (Oestrogens Conjugated) -
    Suspected
    •
    Provera (Medroxyprogesterone
    Acetate) - Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Galactorrhoea
    AU00126439 06/04/1998 - M Anginine (Glyceryl Trinitrate) -
    Suspected
    •
    Betamin (Thiamine Hydrochloride) -
    Suspected
    •
    • Eulexin (Flutamide) - Suspected
    • Not specified (Aspirin) - Suspected
    Not specified (Famotidine) -
    Suspected
    •
    Not specified (Isosorbide Mononitrate)
    - Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Cardiac arrest
    AU00126744 17/04/1998 - M • Anandron (Nilutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Isoptin SR (Verapamil Hydrochloride) -
    Not suspected
    •
    • Not specified (Aspirin) - Not suspected
    Pepcidine (Famotidine) - Not
    suspected
    •
    • Zyloprim (Allopurinol) - Not suspected
    Pulmonary
    fibrosis
    •
    AU00127349 12/05/1998 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Injection site
    reaction
    •
    • Oedema
    • Pruritus
    • Rash
    AU00129517 24/07/1998 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Depression
    AU00130807 07/09/1998 - F Not specified (Somatropin) -
    Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Minitran (Glyceryl Trinitrate) - Not
    suspected
    •
    • Hirsutism
    Report generated 8/10/2012 12:48:28 AM Page 10 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00135194 18/01/1999 73 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Agitation
    • Depression
    • Hot flush
    Personality
    disorder
    •
    AU00137296 16/03/1999 - M • Amfamox (Famotidine) - Suspected
    • Lipex (Simvastatin) - Suspected
    Not specified (Verapamil
    Hydrochloride) - Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Diabetes
    mellitus
    •
    AU00140411 10/06/1999 - M Not specified (Goserelin Acetate) -
    Suspected
    • • Hyperglycaemia
    AU00142076 29/07/1999 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Alopecia
    AU00149663 25/02/2000 - M • Eulexin (Flutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Atrial fibrillation
    Myocardial
    infarction
    •
    • Pneumonia
    AU00150372 10/03/2000 - F Not specified (Amcal Strong Pain
    Plus) - Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Arthralgia
    Oedema
    peripheral
    •
    AU00150334 13/03/2000 - M • Eulexin (Flutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Urinary retention
    AU00161551 15/02/2001 - M • Cosudex (Bicalutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Not specified (Warfarin Sodium) - Not
    suspected
    •
    Polymyalgia
    rheumatica
    •
    AU00166420 11/07/2001 - M Androcur (Cyproterone Acetate) -
    Suspected
    •
    Honvan (Fosfestrol Tetrasodium) -
    Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Coagulopathy
    • Haemorrhage
    Haemorrhage
    intracranial
    •
    • Headache
    • Nausea
    • Purpura
    AU00167279 01/08/2001 45 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Drug ineffective
    Report generated 8/10/2012 12:48:28 AM Page 11 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00169111 05/10/2001 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Blindness
    Confusional
    state
    •
    Haemorrhage
    intracranial
    •
    • Headache
    • Nausea
    • Vomiting
    AU00171674 02/01/2002 71 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Not specified (Calcitriol) - Not
    suspected
    •
    Not specified (Prednisolone) - Not
    suspected
    •
    Not specified (Ranitidine) - Not
    suspected
    •
    Panadeine Forte (Paracetamolcodeine
    Phosphate) - Not suspected
    •
    Renitec (Enalapril Maleate) - Not
    suspected
    •
    • Paraesthesia
    AU00171914 11/01/2002 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Gynaecomastia
    AU00180181 30/10/2002 74 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Betaloc (Metoprolol Tartrate) - Not
    suspected
    •
    Coversyl Plus (Indapamide
    Hemihydrate-perindopril) - Not
    suspected
    •
    • Ikorel (Nicorandil) - Not suspected
    • Lipex (Simvastatin) - Not suspected
    • Not specified (Aspirin) - Not suspected
    Not specified (Omeprazole) - Not
    suspected
    •
    • Pruritus
    Rash maculopapular
    •
    AU00186377 29/05/2003 57 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Depression
    • Suicide attempt
    AU00186971 16/06/2003 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Androcur (Cyproterone Acetate) - Not
    suspected
    •
    Not specified (Calcium Nos) - Not
    suspected
    •
    • Not specified (Zinc) - Not suspected
    Dermatitis
    bullous
    •
    Report generated 8/10/2012 12:48:28 AM Page 12 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00188858 28/07/2003 39 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Dermatitis
    bullous
    •
    AU00188883 28/07/2003 25 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Urticaria
    AU00192440 24/11/2003 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Depression
    AU00196419 13/04/2004 72 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Rash
    erythematous
    •
    • Rash macular
    AU00197481 20/05/2004 - M • Cosudex (Bicalutamide) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Dyspnoea
    AU00201180 24/09/2004 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Not specified (Tamoxifen Citrate) - Not
    suspected
    •
    Psychotic
    disorder
    •
    AU00203514 13/12/2004 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Alcohol
    intolerance
    •
    • Arthralgia
    • Fatigue
    Micturition
    disorder
    •
    • Paraesthesia
    • Vomiting
    Weight
    increased
    •
    Report generated 8/10/2012 12:48:28 AM Page 13 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00203681 20/12/2004 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Adnexa uteri
    pain
    •
    Confusional
    state
    •
    Depersonalisatio
    n
    •
    • Dizziness
    • Endometriosis
    Eustachian tube
    obstruction
    •
    • Eye pain
    • Headache
    • Hyperaesthesia
    • Hypoaesthesia
    • Local reaction
    • Mood swings
    • Nausea
    • Photophobia
    Visual
    impairment
    •
    AU00205171 11/02/2005 67 M Seretide Accuhaler Nos (Fluticasone
    Propionate-salmeterol Xinafoate) -
    Suspected
    •
    • Ventolin (Salbutamol) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Photodermatosis
    AU00210410 05/08/2005 71 M Not specified (Cyproterone Acetate) -
    Suspected
    •
    Not specified (Goserelin Acetate) -
    Suspected
    •
    • Not specified (Aspirin) - Not suspected
    Not specified (Atenolol) - Not
    suspected
    •
    Not specified (Diltiazem
    Hydrochloride) - Not suspected
    •
    • Asthenia
    • Hepatitis
    AU00210658 12/08/2005 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Myocardial
    infarction
    •
    AU00213266 09/11/2005 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Arthralgia
    Report generated 8/10/2012 12:48:28 AM Page 14 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00213536 17/11/2005 38 F Not specified (Goserelin Acetate) -
    Suspected
    • • Chest pain
    Myocardial
    infarction
    •
    Troponin
    increased
    •
    AU00216413 10/03/2006 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Injection site
    abscess
    •
    Injection site
    cellulitis
    •
    AU00219974 13/07/2006 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Oestradiol Implant (Oestradiol) - Not
    suspected
    •
    • Depression
    AU00220463 31/07/2006 63 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Aropax (Paroxetine Hydrochloride) -
    Not suspected
    •
    Cosudex (Bicalutamide) - Not
    suspected
    •
    Not specified (Combivir) - Not
    suspected
    •
    Not specified (Indomethacin) - Not
    suspected
    •
    Not specified (Nevirapine) - Not
    suspected
    •
    Seretide Accuhaler Nos (Fluticasone
    Propionate-salmeterol Xinafoate) - Not
    suspected
    •
    • Ventolin (Salbutamol) - Not suspected
    • Depression
    AU00223277 17/11/2006 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Gravitational
    oedema
    •
    • Rash
    AU00228115 02/05/2007 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Coumadin (Warfarin Sodium) - Not
    suspected
    •
    Isoptin (Verapamil Hydrochloride) -
    Not suspected
    •
    • Lasix (Frusemide) - Not suspected
    • Lipitor (Atorvastatin) - Not suspected
    • Ramace (Ramipril) - Not suspected
    Slow-k (Potassium Chloride) - Not
    suspected
    •
    Pruritus
    generalised
    •
    Report generated 8/10/2012 12:48:28 AM Page 15 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00232129 17/08/2007 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Deep vein
    thrombosis
    •
    AU00232985 04/09/2007 - M • Cosudex (Bicalutamide) - Suspected
    • Feldene (Piroxicam) - Suspected
    Fosamax Once Weekly Tablets
    (Alendronate Sodium) - Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Aristocort (Triamcinolone Acetonide) -
    Not suspected
    •
    Elocon (Mometasone Furoate) - Not
    suspected
    •
    • Gingivitis
    • Lichen planus
    Tongue
    ulceration
    •
    AU00235335 15/11/2007 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Psychotic
    disorder
    •
    AU00235337 15/11/2007 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Psychotic
    disorder
    •
    AU00235456 20/11/2007 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Breast swelling
    • Depression
    • Headache
    • Penis disorder
    Testicular
    disorder
    •
    Visual
    impairment
    •
    • Vomiting
    AU00238922 13/03/2008 - - Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Pulmonary
    embolism
    •
    AU00240092 16/04/2008 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Androcur (Cyproterone Acetate) - Not
    suspected
    •
    Pituitary
    haemorrhage
    •
    Sudden visual
    loss
    •
    AU00240523 01/05/2008 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Phimosis
    AU00240550 05/05/2008 75 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Testicular pain
    AU00241307 28/05/2008 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Testicular pain
    AU00241730 10/06/2008 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Polyarthritis
    Report generated 8/10/2012 12:48:28 AM Page 16 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00241956 16/06/2008 68 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Pain
    • Paraesthesia
    AU00243434 04/08/2008 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Asthenia
    Breast
    tenderness
    •
    • Chills
    Confusional
    state
    •
    • Depression
    Emotional
    disorder
    •
    • Hot flush
    • Hypogonadism
    • Muscle twitching
    • Nightmare
    • Nipple pain
    • Pubic pain
    Visual
    impairment
    •
    AU00243452 04/08/2008 - F Zoladex (Goserelin Acetate) -
    Suspected
    • • Sleep disorder
    AU00244204 28/08/2008 - F • Herceptin (Trastuzumab) - Suspected
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    • Hypoaesthesia
    Neuropathy
    peripheral
    •
    AU00244757 19/09/2008 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Cosudex (Bicalutamide) - Not
    suspected
    •
    Systolic
    hypertension
    •
    AU00247051 10/12/2008 - M Not specified (Clopidogrel) -
    Suspected
    •
    Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Injection site
    haemorrhage
    •
    AU00249685 26/03/2009 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Hot flush
    • Hyperhidrosis
    AU00254369 23/07/2009 84 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Atacand (Candesartan Cilexetil) - Not
    suspected
    •
    Not specified (Doxycycline
    Hydrochloride) - Not suspected
    •
    • Plavix (Clopidogrel) - Not suspected
    • Hypersensitivity
    • Urticaria
    Report generated 8/10/2012 12:48:28 AM Page 17 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00254502 26/07/2009 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Asthenia
    • Fatigue
    AU00261246 21/12/2009 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Rash
    AU00270938 19/07/2010 - M Not specified (Cyproterone Acetate) -
    Suspected
    •
    Not specified (Goserelin Acetate) -
    Suspected
    •
    Not specified (Sotalol Hydrochloride) -
    Suspected
    •
    Pituitary tumour
    benign
    •
    AU00271591 02/08/2010 - - Not specified (Goserelin Acetate) -
    Suspected
    •
    • Zometa (Zoledronic Acid) - Suspected
    • Crying
    Neoplasm
    malignant
    •
    • Pain in extremity
    Prostatic specific
    antigen
    increased
    •
    Weight
    decreased
    •
    AU00272578 24/08/2010 77 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Dry skin
    • Pruritus
    AU00274114 05/10/2010 - M Not specified (Goserelin Acetate) -
    Suspected
    • • Dyspnoea
    • Malaise
    AU00276431 06/12/2010 - F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Autoimmune
    hepatitis
    •
    • Off label use
    AU00278501 09/02/2011 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Disease
    progression
    •
    Neoplasm
    malignant
    •
    AU00279762 10/03/2011 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Disease
    progression
    •
    AU00281189 11/04/2011 88 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Prostate cancer
    AU00281528 15/04/2011 89 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Leukaemia
    • Pneumonia
    • Renal failure
    Report generated 8/10/2012 12:48:28 AM Page 18 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00281615 18/04/2011 70 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Not specified (Insulin Nos) - Not
    suspected
    •
    • Headache
    AU00282073 29/04/2011 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Arterial disorder
    • Metastasis
    Visual acuity
    reduced
    •
    AU00282225 03/05/2011 80 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Bicor (Bisoprolol Fumarate) - Not
    suspected
    •
    Exforge Nos (Amlodipine-Valsartan) -
    Not suspected
    •
    • Lasix (Frusemide) - Not suspected
    • Cardiomegaly
    Pulmonary
    oedema
    •
    AU00282226 03/05/2011 76 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Caltrate (Calcium Carbonate) - Not
    suspected
    •
    • Lipitor (Atorvastatin) - Not suspected
    • Mobic (Meloxicam) - Not suspected
    Not specified (Verapamil
    Hydrochloride) - Not suspected
    •
    • Skin cancer
    AU00282542 09/05/2011 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Cerebrovascular
    accident
    •
    • Cystitis
    Gastrointestinal
    infection
    •
    • Melaena
    • Sepsis
    AU00282547 09/05/2011 72 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Cardiac failure
    • Hip fracture
    • Hyperhidrosis
    • Osteoporosis
    AU00282589 10/05/2011 80 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Cardiac failure
    Prostate cancer
    metastatic
    •
    AU00283002 19/05/2011 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Fall
    Metastases to
    bone
    •
    Report generated 8/10/2012 12:48:28 AM Page 19 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00283138 23/05/2011 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Myocardial
    infarction
    •
    AU00283139 23/05/2011 72 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Cerebrovascular
    accident
    •
    AU00283360 27/05/2011 75 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Brain injury
    Cerebrovascular
    accident
    •
    • Fall
    AU00285011 24/06/2011 75 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Fatigue
    • Hot flush
    Male sexual
    dysfunction
    •
    Skin
    discolouration
    •
    AU00285202 29/06/2011 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Bladder cancer
    Bladder
    neoplasm
    surgery
    •
    • Prostatectomy
    AU00286426 26/07/2011 - M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Cardiac failure
    Weight
    increased
    •
    AU00286552 27/07/2011 88 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Cardiac failure
    AU00287969 25/08/2011 81 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Coronary artery
    bypass
    •
    • Thrombosis
    AU00288406 05/09/2011 47 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Prostate cancer
    AU00289541 26/09/2011 - M Zoladex (Goserelin Acetate) -
    Suspected
    • • Arterial stenosis
    Myocardial
    infarction
    •
    AU00291304 02/11/2011 69 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    •
    Actrapid (Insulin Neutral) - Not
    suspected
    •
    Novorapid (Insulin Aspart) - Not
    suspected
    •
    Blood glucose
    abnormal
    •
    Loss of
    consciousness
    •
    Report generated 8/10/2012 12:48:28 AM Page 20 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00293336 15/12/2011 36 F Zoladex Implant (Goserelin Acetate) -
    Suspected
    • • Pruritus
    Rash
    generalised
    •
    AU00294411 10/01/2012 68 M Zoladex Implant (Goserelin Acetate) -
    Suspected
    • Blood glucose
    increased
    •
    • Hot flush
    Weight
    increased
    •
    AU00294974 24/01/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Staphylococcal
    infection
    •
    AU00295027 25/01/2012 74 M Zoladex (Goserelin Acetate) -
    Suspected
    • Pulmonary
    thrombosis
    •
    AU00295179 30/01/2012 - F Zoladex (Goserelin Acetate) -
    Suspected
    • Maternal
    exposure during
    pregnancy
    •
    • Off label use
    AU00295509 06/02/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Bone neoplasm
    malignant
    •
    • Prostate cancer
    AU00295510 06/02/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    •
    • Not specified (Aspirin) - Not suspected
    Symbicort Turbuhaler (Budesonide-
    Eformoterol Fumarate Dihydrate) - Not
    suspected
    •
    • Hot flush
    • Hypertension
    AU00295835 13/02/2012 63 M Zoladex (Goserelin Acetate) -
    Suspected
    • • Urinary retention
    AU00296097 16/02/2012 82 M Zoladex (Goserelin Acetate) -
    Suspected
    • Haemoglobin
    decreased
    •
    • Hot flush
    AU00297839 23/03/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Prostate cancer
    metastatic
    •
    AU00297841 23/03/2012 62 M Zoladex (Goserelin Acetate) -
    Suspected
    • • Rash
    AU00297945 26/03/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • • Bladder cancer
    AU00298375 02/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • • Injury
    Report generated 8/10/2012 12:48:28 AM Page 21 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00298386 03/04/2012 64 M Not specified (Hydroxychloroquine
    Sulphate) - Suspected
    •
    Not specified (Leflunomide) -
    Suspected
    •
    Not specified (Prednisolone) -
    Suspected
    •
    Zoladex (Goserelin Acetate) -
    Suspected
    •
    • Coversyl (Perindopril) - Not suspected
    Vitamin D Nos (Vitamin Preparation
    Compound) - Not suspected
    •
    Small cell lung
    cancer stage
    unspecified
    •
    AU00298733 11/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Prostate cancer
    metastatic
    •
    AU00298738 11/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • • Prostate cancer
    AU00298739 11/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Disease
    progression
    •
    • Hot flush
    • Osteoarthritis
    AU00298746 11/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Disease
    progression
    •
    AU00298756 11/04/2012 86 M Zoladex (Goserelin Acetate) -
    Suspected
    • Disease
    progression
    •
    • Groin pain
    AU00298765 11/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Multi-organ
    failure
    •
    AU00298888 13/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Neoplasm
    progression
    •
    • Pneumonia
    AU00298889 13/04/2012 74 M Zoladex (Goserelin Acetate) -
    Suspected
    • Neoplasm
    progression
    •
    AU00299001 16/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Neoplasm
    progression
    •
    AU00299004 16/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Neoplasm
    progression
    •
    AU00299006 16/04/2012 71 M Zoladex (Goserelin Acetate) -
    Suspected
    • Myocardial
    infarction
    •
    AU00299007 16/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Neoplasm
    progression
    •
    Report generated 8/10/2012 12:48:28 AM Page 22 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00299009 16/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Myocardial
    infarction
    •
    Neoplasm
    progression
    •
    AU00299091 17/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • • Prostate cancer
    AU00299107 17/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • • Prostate cancer
    AU00299308 20/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • • Throat cancer
    AU00299322 20/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • • Myositis
    • Renal cancer
    AU00299377 23/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Intestinal
    perforation
    •
    • Malaise
    AU00299378 23/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • • Prostate cancer
    AU00299379 23/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Prostate cancer
    metastatic
    •
    AU00299544 26/04/2012 87 M Zoladex (Goserelin Acetate) -
    Suspected
    • Basal cell
    carcinoma
    •
    • Dizziness
    • Joint stiffness
    AU00299588 27/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Myocardial
    infarction
    •
    AU00299675 30/04/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Prostate cancer
    metastatic
    •
    AU00299974 07/05/2012 - F Zoladex (Goserelin Acetate) -
    Suspected
    • • Prostate cancer
    AU00300215 11/05/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • • Prostate cancer
    AU00300225 11/05/2012 82 M Zoladex (Goserelin Acetate) -
    Suspected
    • • Prostate cancer
    AU00301149 28/05/2012 63 M Zoladex (Goserelin Acetate) -
    Suspected
    • Multi-organ
    failure
    •
    Weight
    increased
    •
    Report generated 8/10/2012 12:48:28 AM Page 23 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report.
    Footnotes
    i A unique number that permits reference to a particular case
    ii The date that information from the original report was entered into the database
    iii Age of patient at time of adverse event, '-' if unknown
    iv Gender of patient, '-' if unknown
    v Medicines reported to have been taken by the patient
    vi A description of the adverse event as defined by the Medical Dictionary for Regulatory Activities (MedDRA). You can
    use the MedlinePlus medical dictionary <http://www.nlm.nih.gov/medlineplus/mplusdictionary.html> to look up terms.
    Database of Adverse Event Notifications List of reports
    Case
    numberi
    Report entry
    dateii
    Age
    (yrs)iii
    Genderiv Medicines reported as being takenv MedDRA reaction
    termsvi
    AU00301153 28/05/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Prostate cancer
    metastatic
    •
    AU00301756 07/06/2012 - M • Cosudex (Bicalutamide) - Suspected
    Zoladex (Goserelin Acetate) -
    Suspected
    •
    Disease
    progression
    •
    Prostate cancer
    metastatic
    •
    Prostatic specific
    antigen
    increased
    •
    AU00301858 08/06/2012 - M Zoladex (Goserelin Acetate) -
    Suspected
    • Gastrointestinal
    carcinoma
    •
    Report generated 8/10/2012 12:48:28 AM Page 24 of 24
    The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not
    mean that the medicine is the cause of the adverse event. If you are experiencing an adverse event, or think you may
    be experiencing one, please seek advice from a health professional as soon as possible. The TGA strongly advises
    people taking prescription medicines not to change their medication regime without prior consultation with a health
    professional. Please read all the important information at the beginning of this report

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    Hallo,

    also bisher habe ich folgende Quellen genannt:

    1. Pharmakologische Wirkung, basiert auf Wissensstand 2006 (es gibt neue Studien, habe ich z.T. auch)

    - Myler's adverse drug reaction, 2006 mit sehr vielen Case Reports. Bin selbst dafür in die Bibliothek gegangen. ist ein Kompendium
    - Fachliteratur Pharmakologie, ich habe hier diverses, habe aber nicht die Zeit, dass alles hier rauszusuchen


    2. Nebenwirkungsberichte Canada, Australien, Arzneimitteltelegramm (hier kann man eine Lizenz erwerben)
    http://www.hc-sc.gc.ca/dhp-mps/medeff…n/index-eng.php
    http://www.tga.gov.au/safety/daen.htm
    http://www.arznei-telegramm.de/

    3. Erfahrungsberichte (ask a patient)
    - Link hatte ich schon mal reingestellt, müsste ich in einem alten Beitrag von mir schauen


    4. Rote Liste (Buch mit allen Medikamenten, hat jeder Arzt in seiner Praxis)

    5. Ehemaliger FDA officer Dr. Gueriguian, sein (verkürztes) Gutachten über Lupron (ein GnRH Agonist) findet man wenn man "Lupron" und "Gueriguian" eingibt. Hatte ich schon mal hier reingestellt.


    Bitte selbst lesen und dann Ärzte befragen, insbesondere nach dem Wirkmechanismus ausserhalb der hypothalamus hypophysenachse, das kann euch keiner abnehmen! Ich weiss es kostet Zeit, aber es lohnt sich meines Erachtens. Ich hätte es mal vor GnRH Spritzen machen sollen.

    Gruss
    heiker

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    Hallo Claudi & Chris,

    die Quellenangaben sind in meinen diversen Eintragungen hier im Forum enthalten. Könntet ihr die lesen? Wenn dann noch was fehlt, gebe ich gern weitere Quellen an.

    Mir ist gerade noch aufgefallen, eine Quelle habe ich noch nicht genannt: Myler's Side Effects of Drugs, Ausgabe 2006. Dort sind viele weitere Quellen genannt. Und dann natürlich noch der Beipackzettel.

    Mehr kann ich nun wirklich nicht tun. Lesen muss das jeder selbst, wenn er mag.

    Gruss
    heiker

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    Herr Dr. K,

    Sie antworten auf meine Fragen nicht, z.B. was ist der Wirkmechanismus von GnRH. Wenn er überall verfügbar ist, warum können Sie ihn dann für uns alle nicht ganz allgemeinverständlich beschreiben?
    Quellenangaben habe ich an anderer Stelle bereits gemacht. Ich weiss wirklich nicht, warum Sie meine Beiträge nicht mal anschauen können, incl. der Quellenangaben. Wenn sie nach deren Studium der Ansicht sind, dass die Nebenwirkungsberichte auf den offiziellen Seiten der Pharmaaufsicht Australien und Canada sowie im Arzneimitteltelegramm Gerüchte sein sollen, bitte ich Sie, mir mal die Gründe hierfür zu erklären. Bevor Sie meine Quellen nicht gelesen haben, bringen weitere Diskussionen hier gar nichts.

    Bezüglich der FDA und EMA Warnung haben Sie sogar als Arzt noch besser Möglichkeiten, welche Informationen von dort veröffentlicht werden.
    EMA
    Pharmacovigilance Working Party (PhVWP)
    December 2011 plenary meeting
    http://www.emea.europa.eu/docs/en_GB/doc…WC500120115.pdf
    Gonatropin-releasing hormone (GnRH) agonists – Risk of depression
    Some evidence suggests that gonatropin-releasing hormone (GnRH) agonists are associated with an increased risk of depression, which may be severe, and their product information should be updated consistently across the EU.
    Following reports of severe depression including suicide from a Japanese survey and a further epidemiological study in the UK, the PhVWP conducted a review of gonatropin-releasing hormone (GnRH) agonists and the risk of depression. The PhVWP concluded that the risk of depression and mood changes should be mentioned and warnings should be included, in a consistent manner and for
    all indications, in the product information of all medicinal products in the EU containing a GnRH agonist2 (see Annex 1 for the Summary Assessment Report).
    The PhVWP informed the CMDh accordingly. For the final wording to be included in the summaries of product characteristics (SmPCs) and package leaflets (PLs), as well as practical information on implementation, interested readers are advised to consult the HMA website (http://www.hma.eu/cmdh.html) for upcoming information.


    @alle: Ich kann nur nochmal dringend empfehlen, die Quellen zu GnRH Nebenwirkungen im Internet und die Infos zur pharmakologischen Wirkweise aufmerksam SELBST zu studieren. Zunächst braucht man die Wirkstoffe (Beipackzettel), dann die Markennamen und los gehts. Leider ist das alles vor allen Dingen auf englisch, aber das kann ich nicht ändern.

    Gruss
    heiker

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?

    Hallo Dr. K,

    ich möchte Sie bitten, mir meine Fragen zu beantworten bevor Sie mir welche stellen. Nach dem Wirkmechanismus des Medikamentes hatte ich Sie gefragt, aber anstelle von Antworten, kommen nur Fragen.

    Zu den schweren Nebenwirkungen möchte ich nochmal auf die genannten Quellen hinweisen. Bitte lesen Sie diese zunächst. da bekommen Sie Antwort auf Ihre Frage welcher Krebs sich in engem zeitlichen Zusammenhang entwickelt hat. Ich kann hier nicht die ganzen Nebenwirkungsberichte ins Netz stellen. Das geht technisch nicht.

    Gruss
    heiker

  • Fatale Nebenwirkungen durch Downregulation?

    Re: Fatale Nebenwirkungen durch Downregulation?


    Hallo Dr. K,

    Wahrscheinlich richtet sich Ihre Nachricht nicht an Leerhuhn, sondern mich.

    Da Sie sich so sicher sind, bitte ich zu schreiben, wie Sie in Ihrer Praxis feststellen, dass es keine langfristigen Nebenwirkungen gibt. Gibt es z.B. ein Anamneseformular, welches Beschwerden systematisch nach ½ Jahr, 1 Jahr oder 2 Jahren erfasst? Welche Follow ups werden von Ihnen gemacht?

    Es gibt nicht „einen“ Fall sondern Tausende (siehe Warnungen EMA, FDA), im übrigen auch nicht nur bei Fertilitätsbehandlungen sondern auch Endometriose und Prostatakarzinom. Welcher von diesen Kongressen, die Sie erwähnten besucht zu haben, nicht von der Pharmaindustrie gesponsert war, würde mich interessieren.

    Interessant wären auch fachliche Informationen über den Wirkmechanismus von Ihnen. Ich habe eine ganze Reihe von Fragen. Kennen Sie sich mit der Wirkweise von GnRH auf Gewebe (Rezeptoren) ausserhalb der Hyptothalamus-Hypophysenachse aus? Fragen habe ich auch zu den Unterschiede der einzelnen GnRHs - gibt es hier überhaupt welche in bezug auf das Nebenwirkungsprofil?

    Meine Infos beziehen sich auf Nebenwirkungsberichten von Canada, Australien, Arzneimitteltelegramm Deutschland sowie auf der Literatur und natürlich meinen eigenen Erfahrungen.

    Es würde mich freuen, wenn Sie bei Ihrem nächsten Kongress selbst mal rumfragen.

    Gruss
    heiker