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Klexane Safety Reports submitted to FDA

Total Klexane reports: 3.
Klexane FDA safety alerts: No.
   Reported hospitalizations: 2.
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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 #5252547-6
Consumer or non-health professional from reported KLEXANE problem on Feb 21, 2007. Male patient, 86 years of age, was treated with KLEXANE. After drug was administered, patient experienced the following problems/side effects: angioedema, hypersensitivity. KLEXANE dosage: unknown. Patient recovered.

Klexane Side Effects Report #5321212-9
KLEXANE problem was reported by a Physician from DENMARK on Apr 30, 2007. Female patient, 81 years of age, was diagnosed with thrombosis prophylaxis and was treated with KLEXANE. After drug was administered, patient experienced the following problems/side effects: skin necrosis. KLEXANE dosage: unknown. 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.


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angioedema, hypersensitivity skin necrosis erosive duodenitis, gastric ulcer haemorrhage, gastrointestinal haemorrhage, haematemesis, haemoglobin decreased, hypotension, melaena, myocardial infarction, was diagnosed with thrombosis prophylaxis and