FDA: Octagam Voluntarily Withdrawn From U.S. Market

Immune globulin product may be associated with a higher risk of thromboembolic events
By Beth Gilbert
HealthDay Reporter

MONDAY, Sept. 27 (HealthDay News) -- Octapharma and the U.S. Food and Drug Administration have announced a voluntary market withdrawal of all lots of Immune Globulin Intravenous (human) 5 percent Liquid Preparation (Octagam) currently in the U.S. market, as the drug is potentially associated with an increased number of thromboembolic events.

Immune Globulin Intravenous (human) 5 percent Liquid Preparation is indicated for the treatment of primary humoral immunodeficiency, which includes congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

On Aug. 20, Octapharma withdrew 31 lots of the drug due to an increased number of thromboembolic events. There were nine thromboembolic events potentially associated with seven of those 31 lots. Octapharma, in collaboration with the FDA, developed advanced testing methodologies to determine the potential for a higher risk of thromboembolic events with intravenous immune globulin products. This testing raised concerns with 24 additional lots of the drug. While no additional thromboembolic events have been reported since that date, the company has now withdrawn all lots of the drug, as the root cause of these events has yet to be determined

According to an FDA safety alert, "customers are asked to immediately quarantine the use of affected lots and to contact Octapharma's Customer Service Department to arrange for product return."

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