September 24, 2010
Market withdrawal of octagamOctapharma announced that it has initiated a voluntary market withdrawal of all lots of octagam (immune globulin [human]). On August 20, 2010, Octapharma initiated a voluntary market withdrawal of selected lots of octagam as a result of an increased number of reported thromboembolic events, some of which were serious. A total of 31 lots were voluntarily withdrawn at that time.
While Octapharma has not received any reports of thromboembolic events after advanced testing and the above voluntary market withdrawal was performed, 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.
Octagam is indicated for the treatment of primary humoral immunodeficiency (eg, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
For more information call (888) 429-4535 or visit www.octapharma.com.