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Review Kefral Safety Reports submitted to FDA

Total Kefral reports: 5.
Kefral FDA safety alerts: No.
Reported deaths: 3    Reported hospitalizations: 2.
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FDA Reported Kefral Side Effects: liver disorder, jaundice, gamma-glutamyltransferase increased, enterococcal infection, culture urine positive, atrial fibrillation, aspartate aminotransferase increased, alanine aminotransferase increased, thrombotic thrombocytopenic purpura, lymphocyte stimulation test positive, emphysematous cholecystitis.
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Kefral Side Effects Report #5646909-2
Physician from JAPAN reported KEFRAL problem on Feb 25, 2008. Male patient was diagnosed with otitis media, bronchial disorder, sputum retention, rhinorrhoea and was treated with KEFRAL. After drug was administered, patient experienced the following problems/side effects: hepatitis fulminant, liver transplant, multi-organ failure. KEFRAL dosage: 210 MG, DAILY (1/D). During the same period patient was treated with VENETLIN, ASVERIN, MUCOSOLATE, PERIACTIN. Patient died.

Kefral Side Effects Report #5688229-6
KEFRAL problem was reported by a Physician from JAPAN on Dec 26, 2007. Male patient was diagnosed with otitis media, bronchial disorder, sputum retention, rhinorrhoea and was treated with KEFRAL. After drug was administered, patient experienced the following problems/side effects: hepatitis fulminant. KEFRAL dosage: 210 MG, DAILY (1/D). During the same period patient was treated with VENETLIN, ASVERIN, MUCOSOLATE, PERIACTIN. Patient died.

Kefral Side Effects Report #5612757-2
Physician from JAPAN reported KEFRAL problem on Jan 24, 2008. Male patient was diagnosed with otitis media, bronchial disorder, sputum retention, rhinorrhoea and was treated with KEFRAL. After drug was administered, patient experienced the following problems/side effects: hepatitis fulminant. KEFRAL dosage: 210 MG, DAILY (1/D). During the same period patient was treated with VENETLIN, ASVERIN, MUCOSOLATE, PERIACTIN. Patient died.

Kefral Side Effects Report #5383274-2
KEFRAL problem was reported by a Physician from JAPAN on July 04, 2007. Male patient, 57 years of age, was diagnosed with tooth infection and was treated with KEFRAL. After drug was administered, patient experienced the following problems/side effects: emphysematous cholecystitis, thrombotic thrombocytopenic purpura. KEFRAL dosage: unknown. During the same period patient was treated with MEFENAMIC ACID. Patient was hospitalized. Patient recovered.

Kefral Side Effects Report #5383274-2
Physician from JAPAN reported KEFRAL problem on July 04, 2007. Male patient, 57 years of age, was diagnosed with tooth infection and was treated with KEFRAL. After drug was administered, patient experienced the following problems/side effects: emphysematous cholecystitis, thrombotic thrombocytopenic purpura. KEFRAL dosage: unknown. During the same period patient was treated with MEFENAMIC ACID. Patient was hospitalized. Patient recovered.


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hepatitis fulminant, liver transplant, multi-organ failure, hepatitis fulminant, hepatitis fulminant, , was diagnosed with otitis media, bronchial disorder, sputum retention, rhinorrhoea and was diagnosed with otitis media, bronchial disorder, sputum retention, rhinorrhoea and