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Review Depakine Safety Reports submitted to FDA

Total Depakine reports: 10.
Depakine FDA safety alerts: No.
   Reported hospitalizations: 8.
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FDA Reported Depakine Side Effects: transaminases increased, thrombocytopenia, pulmonary congestion, petechiae, hyperthermia, hepatic failure, diarrhoea, cough, convulsion, fall, disturbance in attention.
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Depakine Side Effects Report #5647305-4
Physician from FRANCE reported DEPAKINE problem on Feb 22, 2008. Female patient, 52 years of age, was diagnosed with grand mal convulsion and was treated with DEPAKINE. After drug was administered, patient experienced the following problems/side effects: osteopenia. DEPAKINE dosage: unknown. Patient recovered.

Depakine Side Effects Report #5662264-6
DEPAKINE problem was reported by a Physician from FRANCE on Mar 06, 2008. Female patient, 52 years of age, was diagnosed with grand mal convulsion and was treated with DEPAKINE. After drug was administered, patient experienced the following problems/side effects: osteopenia. DEPAKINE dosage: unknown. Patient recovered.

Depakine Side Effects Report #5618627-8
Consumer or non-health professional from FRANCE reported DEPAKINE problem on Jan 28, 2008. Female patient, 73 years of age, was treated with DEPAKINE. After drug was administered, patient experienced the following problems/side effects: blood lactate dehydrogenase increased, cholelithiasis, hepatocellular injury, hepatotoxicity. DEPAKINE dosage: unknown. During the same period patient was treated with DEPAKINE CHRONOSPHERE GRANULE, DEPAKINE CHRONOSPHERE GRANULE, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Depakine Side Effects Report #5510172-3
DEPAKINE problem was reported by a Health Professional from FRANCE on Oct 30, 2007. Male patient, 28 years of age, was treated with DEPAKINE. After drug was administered, patient experienced the following problems/side effects: bipolar disorder. DEPAKINE dosage: unknown. During the same period patient was treated with DIAZEPAM, LANOLEPT, AMISULPRIDE. Patient recovered.

Depakine Side Effects Report #5494487-3
Physician from FRANCE reported DEPAKINE problem on Oct 15, 2007. Female patient, 71 years of age, was diagnosed with epilepsy, myocardial ischaemia, cerebral infarction and was treated with DEPAKINE. After drug was administered, patient experienced the following problems/side effects: alopecia, colitis collagenous, diarrhoea. DEPAKINE dosage: unknown. During the same period patient was treated with CLOPIDOGREL, ISOSORBIDE MONONITRATE, FUROSEMIDE, POTASSIUM CHLORIDE, TELMISARTAN, SIMVASTATIN, ACETYLSALICYLIC ACID SRT. Patient recovered.

Depakine Side Effects Report #5378811-8
DEPAKINE problem was reported by a Health Professional from FRANCE on June 27, 2007. Male patient, child 8 years of age, was treated with DEPAKINE. After drug was administered, patient experienced the following problems/side effects: convulsion, cough, diarrhoea, hepatic failure, hyperthermia, petechiae, pulmonary congestion, thrombocytopenia, transaminases increased. DEPAKINE dosage: unknown. During the same period patient was treated with OXCARBAZEPINE, TOPIRAMATE, BACLOFEN, DOMPERIDONE, MOVICOL. Patient was hospitalized. Patient recovered.

Depakine Side Effects Report #5378811-8
Health Professional from FRANCE reported DEPAKINE problem on June 27, 2007. Male patient, child 8 years of age, was treated with DEPAKINE. After drug was administered, patient experienced the following problems/side effects: convulsion, cough, diarrhoea, hepatic failure, hyperthermia, petechiae, pulmonary congestion, thrombocytopenia, transaminases increased. DEPAKINE dosage: unknown. During the same period patient was treated with OXCARBAZEPINE, TOPIRAMATE, BACLOFEN, DOMPERIDONE, MOVICOL. Patient was hospitalized. Patient recovered.

Depakine Side Effects Report #5739604-2
DEPAKINE problem was reported by a Physician from FRANCE on May 05, 2008. Male patient, 17 years of age, was treated with DEPAKINE. After drug was administered, patient experienced the following problems/side effects: lymphoproliferative disorder. DEPAKINE dosage: unknown. Patient recovered.

Depakine Side Effects Report #5716473-8
Health Professional from FRANCE reported DEPAKINE problem on Apr 14, 2008. Female patient, 16 years of age, was diagnosed with epilepsy, autism and was treated with DEPAKINE. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, aggression, anxiety, decreased appetite, diarrhoea, hyperhidrosis, insomnia, nausea, restlessness. DEPAKINE dosage: unknown. During the same period patient was treated with DEPAKINE CHRONOSPHERE, DEPAKINE CHRONOSPHERE, DEPAKINE CHRONOSPHERE, RISPERIDONE. Patient was hospitalized. Patient recovered.

Depakine Side Effects Report #5343118-1
DEPAKINE problem was reported by a Health Professional from FRANCE on May 23, 2007. Female patient, 81 years of age, was diagnosed with epilepsy, hypothyroidism and was treated with DEPAKINE. After drug was administered, patient experienced the following problems/side effects: aphasia, arrhythmia, atrial fibrillation, cerebral atrophy, cerebral ventricle dilatation, disorientation, disturbance in attention, fall. DEPAKINE dosage: unknown. During the same period patient was treated with PAROXETINE, CLOBAZAM, RAMIPRIL, FUROSEMIDE, LEVETIRACETAM, LEVOTHYROXINE, AMLODIPINE BESYLATE, ALENDRONATE. Patient was hospitalized. Patient recovered.


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osteopenia, osteopenia, blood lactate dehydrogenase increased, cholelithiasis, hepatocellular injury, hepatotoxicity, , was diagnosed with grand mal convulsion and was diagnosed with grand mal convulsion and was diagnosed with epilepsy, myocardial ischaemia, cerebral infarction and