Octagam Withdrawn From Market Over Unresolved Blood Clots, Embolisms

Disclosures

September 24, 2010

September 24, 2010 — Octapharma USA is voluntarily withdrawing all lots of immune globulin G (IgG) intravenous (human) 5% liquid preparation (Octagam) in the United States while it investigates blood clots and embolisms linked with the biologic, the US Food and Drug Administration (FDA) announced yesterday.

This intravenous IgG product is approved to treat primary immunodeficiency diseases such as congenital agammaglobulinemia and hypogammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. On August 24, the FDA announced that Octapharma USA was voluntarily recalling 31 lots of the product based on increased reports of thromboembolic events.

Yesterday, at the agency's request, the company began to withdraw all lots of IgG intravenous 5% liquid preparation in the United States.

"The FDA and Octapharma agree that until a root cause of the previously reported thromboembolic events can be determined, the most prudent course of action is to suspend further administration of Octagam," the company stated in a press release. It noted that it has not learned of any additional thromboembolic events associated with the product since the August recall.

The action in the United States coincides with an recommendation today by the European Medicines Agency (EMA) to suspend market authorizations for the IgG product and recall all lots of it currently on the market in 28 European countries due to an unexpected increase in thromboembolic events. Physicians should stop administering the product and switch patients to the most appropriate alternative treatment, according to an announcement by the EMA.

The EMA stated that the increase in thromboembolic events "is thought to be related to problems with the medicine's manufacturing process."

The suspension will remain in place until the manufacturer rectifies the problem, The EMA recommendation goes to the EU's executive body — the European Commission — for its approval.

More information about yesterday's FDA announcement is available on the agency's Web site.

To report adverse events related to IgG intravenous 5% liquid preparation, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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