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Review Helixate Safety Reports submitted to FDA

Total Helixate reports: 11.
Helixate FDA safety alerts: No.
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FDA Reported Helixate Side Effects: factor viii inhibition, anti factor viii antibody positive, pneumonia, monocytosis, leukocytosis, hypoxia, acute respiratory distress syndrome, haemorrhage, inhibiting antibodies, central venous catheterisation, pyrexia.
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Helixate Side Effects Report #5592752-2
Health Professional from FRANCE reported HELIXATE problem on Jan 11, 2008. Male patient, child 2 years of age, was diagnosed with factor viii deficiency and was treated with HELIXATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition, injection site extravasation. HELIXATE dosage: unknown. Patient recovered.

Helixate Side Effects Report #5483268-2
HELIXATE problem was reported by a Health Professional from FRANCE on Sept 09, 2007. Male patient, child 2 years of age, was diagnosed with factor viii deficiency and was treated with HELIXATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition. HELIXATE dosage: unknown. Patient recovered.

Helixate Side Effects Report #5462466-8
Health Professional from FRANCE reported HELIXATE problem on Sept 09, 2007. Male patient, child 2 years of age, was diagnosed with factor viii deficiency and was treated with HELIXATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition. HELIXATE dosage: unknown. During the same period patient was treated with HELIXATE NEXGEN, HELIXATE NEXGEN, HELIXATE NEXGEN, HELIXATE NEXGEN, HELIXATE NEXGEN, HELIXATE NEXGEN, HELIXATE NEXGEN, HELIXATE NEXGEN. Patient recovered.

Helixate Side Effects Report #5443188-6
HELIXATE problem was reported by a Consumer or non-health professional from FRANCE on Aug 14, 2007. Male patient, 30 years of age, was diagnosed with factor viii deficiency and was treated with HELIXATE. After drug was administered, patient experienced the following problems/side effects: anti factor viii antibody positive. HELIXATE dosage: unknown. Patient recovered.

Helixate Side Effects Report #5443190-4
Consumer or non-health professional from FRANCE reported HELIXATE problem on Aug 13, 2007. Male patient was diagnosed with factor viii deficiency and was treated with HELIXATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition. HELIXATE dosage: unknown. Patient recovered.

Helixate Side Effects Report #5443195-3
HELIXATE problem was reported by a Consumer or non-health professional from GERMANY on Aug 13, 2007. Male patient was diagnosed with factor viii deficiency and was treated with HELIXATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition, inhibiting antibodies. HELIXATE dosage: unknown. Patient recovered.

Helixate Side Effects Report #5443198-9
Consumer or non-health professional from FRANCE reported HELIXATE problem on Aug 14, 2007. Male patient, 30 years of age, was diagnosed with factor viii deficiency and was treated with HELIXATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition. HELIXATE dosage: unknown. Patient recovered.

Helixate Side Effects Report #5449833-3
HELIXATE problem was reported by a Consumer or non-health professional from FRANCE on Aug 22, 2007. Male patient, 30 years of age, was diagnosed with factor viii deficiency and was treated with HELIXATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition. HELIXATE dosage: unknown. Patient recovered.

Helixate Side Effects Report #5368473-8
Physician from UNITED KINGDOM reported HELIXATE problem on Mar 21, 2007. Male patient, 36 years of age, was diagnosed with factor viii deficiency and was treated with HELIXATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition, haemorrhage. HELIXATE dosage: unknown. During the same period patient was treated with MONOCLATE, MONARC. Patient recovered.

Helixate Side Effects Report #5378290-0
HELIXATE problem was reported by a Physician from UNITED KINGDOM on Mar 21, 2007. Male patient, 36 years of age, was diagnosed with factor viii deficiency and was treated with HELIXATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition, haemorrhage. HELIXATE dosage: unknown. During the same period patient was treated with MONOCLATE, MONARC. Patient recovered.

Helixate Side Effects Report #5369835-5
Consumer or non-health professional from UNITED KINGDOM reported HELIXATE problem on May 21, 2007. Male patient, 27 years of age, weighting 176.1 lb, was diagnosed with factor viii deficiency and was treated with HELIXATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition. HELIXATE dosage: unknown. Patient recovered.


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