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Review Cymevan Safety Reports submitted to FDA

Total Cymevan reports: 5.
Cymevan FDA safety alerts: No.
Reported deaths: 3    Reported hospitalizations: 4.
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FDA Reported Cymevan Side Effects: bone marrow failure, rhabdomyolysis, nervous system disorder, cardiac disorder, bradycardia, vomiting, gamma-glutamyltransferase increased, cytolytic hepatitis, tachycardia, respiratory disorder, renal disorder.
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Cymevan Side Effects Report #5684976-0
Health Professional from FRANCE reported CYMEVAN problem on Sept 14, 1998. Male patient, 67 years of age, weighting 132.3 lb, was treated with CYMEVAN. After drug was administered, patient experienced the following problems/side effects: vasculitis. CYMEVAN dosage: unknown. During the same period patient was treated with FORTUM, TRIFLUCAN, IMMUNE GLOBULIN INTRAVENOUS. Patient was hospitalized. Patient died on 07/05/1996.

Cymevan Side Effects Report #5565551-5
CYMEVAN problem was reported by a Physician from FRANCE on Aug 17, 2005. Male patient, 68 years of age, was treated with CYMEVAN. After drug was administered, patient experienced the following problems/side effects: cardiovascular disorder, neutropenia, renal failure, respiratory distress, sepsis. CYMEVAN dosage: unknown. Patient was hospitalized. Patient died on 06/25/2003.

Cymevan Side Effects Report #5567068-0
Pharmacist from FRANCE reported CYMEVAN problem on Aug 21, 2006. Male patient, 75 years of age, was treated with CYMEVAN. After drug was administered, patient experienced the following problems/side effects: anaemia, lung neoplasm malignant. CYMEVAN dosage: unknown. During the same period patient was treated with LASILIX, PREVISCAN. Patient died on 07/21/2006.

Cymevan Side Effects Report #5525373-8
CYMEVAN problem was reported by a Physician from FRANCE on Nov 16, 2007. Male patient, 53 years of age, was treated with CYMEVAN. After drug was administered, patient experienced the following problems/side effects: bone marrow failure. CYMEVAN dosage: unknown. During the same period patient was treated with FOSCAVIR. Patient was hospitalized. Patient recovered.

Cymevan Side Effects Report #5467190-3
Health Professional from FRANCE reported CYMEVAN problem on Sept 14, 2007. Male patient, 48 years of age, weighting 176.4 lb, was treated with CYMEVAN. After drug was administered, patient experienced the following problems/side effects: cytolytic hepatitis, gamma-glutamyltransferase increased, vomiting. CYMEVAN dosage: unknown. During the same period patient was treated with ROVALCYTE, INIPOMP, RIFADIN, RIMIFON, PYRAZINAMIDE, ETHAMBUTOL. Patient was hospitalized. Patient recovered.


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vasculitis, cardiovascular disorder, neutropenia, renal failure, respiratory distress, sepsis, anaemia, lung neoplasm malignant, ,