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Review Goserelin Safety Reports submitted to FDA

Total Goserelin reports: 7.
Goserelin FDA safety alerts: No.
Reported deaths: 4    .
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FDA Reported Goserelin Side Effects: depression, completed suicide, pancytopenia.
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Goserelin Side Effects Report #5479738-3
Health Professional from JAPAN reported GOSERELIN problem on Sept 27, 2007. Male patient, 81 years of age, was diagnosed with prostate cancer and was treated with GOSERELIN. After drug was administered, patient experienced the following problems/side effects: injection site nodule. GOSERELIN dosage: unknown. During the same period patient was treated with LEUPROLIDE ACETATE, LEUPROLIDE ACETATE. Patient recovered.

Goserelin Side Effects Report #5385480-X
GOSERELIN problem was reported by a Health Professional from UNITED KINGDOM on July 10, 2007. Female patient, 36 years of age, was diagnosed with endometriosis, depression, anxiety and was treated with GOSERELIN. After drug was administered, patient experienced the following problems/side effects: completed suicide, depression. GOSERELIN dosage: unknown. During the same period patient was treated with CITALOPRAM HYDROBROMIDE, LORAZEPAM. Patient died on 06/02/2007.

Goserelin Side Effects Report #5394172-2
Health Professional from UNITED KINGDOM reported GOSERELIN problem on July 18, 2007. Female patient, 36 years of age, was diagnosed with endometriosis, depression, anxiety and was treated with GOSERELIN. After drug was administered, patient experienced the following problems/side effects: completed suicide, depression. GOSERELIN dosage: unknown. During the same period patient was treated with CITALOPRAM, LORAZEPAM. Patient died on 06/02/2007.

Goserelin Side Effects Report #5385480-X
GOSERELIN problem was reported by a Health Professional from UNITED KINGDOM on July 10, 2007. Female patient, 36 years of age, was diagnosed with endometriosis, depression, anxiety and was treated with GOSERELIN. After drug was administered, patient experienced the following problems/side effects: completed suicide, depression. GOSERELIN dosage: unknown. During the same period patient was treated with CITALOPRAM HYDROBROMIDE, LORAZEPAM. Patient died on 06/02/2007.

Goserelin Side Effects Report #5394172-2
Health Professional from UNITED KINGDOM reported GOSERELIN problem on July 18, 2007. Female patient, 36 years of age, was diagnosed with endometriosis, depression, anxiety and was treated with GOSERELIN. After drug was administered, patient experienced the following problems/side effects: completed suicide, depression. GOSERELIN dosage: unknown. During the same period patient was treated with CITALOPRAM, LORAZEPAM. Patient died on 06/02/2007.

Goserelin Side Effects Report #5761279-7
GOSERELIN problem was reported by a Health Professional from JAPAN on June 03, 2008. Male patient, 77 years of age, was diagnosed with prostate cancer and was treated with GOSERELIN. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease. GOSERELIN dosage: unknown. Patient recovered.

Goserelin Side Effects Report #5313699-2
Physician from UNITED KINGDOM reported GOSERELIN problem on Apr 18, 2007. Male patient, 78 years of age, weighting 167.6 lb, was diagnosed with prostate cancer, myelodysplastic syndrome and was treated with GOSERELIN. After drug was administered, patient experienced the following problems/side effects: pancytopenia. GOSERELIN dosage: unknown. Patient recovered.


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