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Review Factor Safety Reports submitted to FDA

Total Factor reports: 3.
Factor FDA safety alerts: 2001 2003 2004 2005 2006 2007 2008 .
   Reported hospitalizations: 2.
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FDA Reported Factor Side Effects: thrombotic thrombocytopenic purpura, renal tubular necrosis, renal failure acute, red blood cell schistocytes present, oliguria, microangiopathy, haemoglobin decreased, haemodialysis, catheter related complication, venous thrombosis, infusion site thrombosis.
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Factor Side Effects Report #5419113-0
Pharmacist from UNITED STATES reported FACTOR problem on Aug 16, 2007. Female patient, 74 years of age, weighting 198.9 lb, was diagnosed with haemorrhage intracranial, hypocoagulable state and was treated with FACTOR. After drug was administered, patient experienced the following problems/side effects: infusion site thrombosis, venous thrombosis. FACTOR dosage: unknown. During the same period patient was treated with FACTOR IX CONCENTRATE. Patient was hospitalized. Patient recovered.

Factor Side Effects Report #5419114-2
FACTOR problem was reported by a Pharmacist from UNITED STATES on Aug 16, 2007. Female patient, 49 years of age, weighting 113.1 lb, was diagnosed with haemorrhage, international normalised ratio increased, colon cancer metastatic and was treated with FACTOR. After drug was administered, patient experienced the following problems/side effects: catheter related complication, haemodialysis, haemoglobin decreased, microangiopathy, oliguria, red blood cell schistocytes present, renal failure acute, renal tubular necrosis, thrombotic thrombocytopenic purpura. FACTOR dosage: unknown. During the same period patient was treated with FACTOR IX CONCENTRATE, AVASTIN. Patient was hospitalized. Patient recovered.

Factor Side Effects Report #5771801-2
Physician from THAILAND reported FACTOR problem on May 12, 2008. Male patient, child 10 years of age, was diagnosed with factor viii deficiency and was treated with FACTOR. After drug was administered, patient experienced the following problems/side effects: factor ix inhibition. FACTOR dosage: unknown. Patient recovered.


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infusion site thrombosis, venous thrombosis, catheter related complication, haemodialysis, haemoglobin decreased, microangiopathy, oliguria, red blood cell schistocytes present, renal failure acute, renal tubular necrosis, thrombotic thrombocytopenic purpura, , was diagnosed with haemorrhage intracranial, hypocoagulable state and was diagnosed with haemorrhage, international normalised ratio increased, colon cancer metastatic and