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Review Klexane Safety Reports submitted to FDA

Total Klexane reports: 4.
Klexane FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Klexane Side Effects: myocardial infarction, melaena, hypotension, haemoglobin decreased, haematemesis, gastrointestinal haemorrhage, gastric ulcer haemorrhage, erosive duodenitis, skin necrosis, hypersensitivity, angioedema.
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Klexane Side Effects Report #5573526-5
Physician from NORWAY reported KLEXANE problem on Dec 18, 2007. Female patient, 80 years of age, was diagnosed with atrial fibrillation and was treated with KLEXANE. After drug was administered, patient experienced the following problems/side effects: intra-abdominal haematoma, neutropenia. KLEXANE dosage: unknown. During the same period patient was treated with MAREVAN, CIPROXIN. Patient recovered.

Klexane Side Effects Report #5494982-7
KLEXANE problem was reported by a Consumer or non-health professional from on Oct 18, 2007. Female patient, 79 years of age, was treated with KLEXANE. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, subarachnoid haemorrhage. KLEXANE dosage: unknown. During the same period patient was treated with PLAVIX, TROMBYL. Patient was hospitalized. Patient recovered.

Klexane Side Effects Report #5395147-X
Physician from FINLAND reported KLEXANE problem on July 17, 2007. Male patient, 76 years of age, was treated with KLEXANE. After drug was administered, patient experienced the following problems/side effects: erosive duodenitis, gastric ulcer haemorrhage, gastrointestinal haemorrhage, haematemesis, haemoglobin decreased, hypotension, melaena, myocardial infarction. KLEXANE dosage: unknown. During the same period patient was treated with PLAVIX, MAREVAN, ASPIRIN, MICARDIS HCT, BETAXOLOL, DIGOXIN, CRESTOR. Patient was hospitalized. Patient recovered.

Klexane Side Effects Report #5395147-X
KLEXANE problem was reported by a Physician from FINLAND on July 17, 2007. Male patient, 76 years of age, was treated with KLEXANE. After drug was administered, patient experienced the following problems/side effects: erosive duodenitis, gastric ulcer haemorrhage, gastrointestinal haemorrhage, haematemesis, haemoglobin decreased, hypotension, melaena, myocardial infarction. KLEXANE dosage: unknown. During the same period patient was treated with PLAVIX, MAREVAN, ASPIRIN, MICARDIS HCT, BETAXOLOL, DIGOXIN, CRESTOR. Patient was hospitalized. Patient recovered.


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intra-abdominal haematoma, neutropenia, gastrointestinal haemorrhage, subarachnoid haemorrhage, erosive duodenitis, gastric ulcer haemorrhage, gastrointestinal haemorrhage, haematemesis, haemoglobin decreased, hypotension, melaena, myocardial infarction, , was diagnosed with atrial fibrillation and