Octagam Recall Issued for Select Lots Due to Risk of Thromboembolism

Selected lots of octagam, an immune system deficiency drug, are being pulled from hospital inventories due to the possibility that it could increase the risk of blood clots and embolisms. 

Last week the FDA announced that Octapharma USA Inc. was initiating an octagam recall due to an unusually high number of thormoboembolic events that have been associated with people taking the drug. Some of the patients given the drug were seriously injured.

Octagam (immune globulin intravenous (human) 5% liquid preparation) is an immune deficiency treatment drug approved by FDA in 2004. It is made using sterilized human plasma.

According to the recall announcement, there were at least nine events where blood clots dislodged and traveled through the body, causing injury and pain to patients. The events have been linked with seven particular lots of octagam. The FDA and Octapharma developed methods of testing to detect which lots of the drug are likely to cause increased risk of embolism and identified 24 more lots of the drug which could be dangerous to patients. However, it has not been conclusively determined that the octagam caused the thromboembolic events.

The recall of octagam affects 31 lots of the medication that were distributed in vial sizes of 5 gms and 10 gms. They have expiration dates ranging from January 11, 2012 to June 23, 2012. A full list of the lot numbers affected by the octagam recall is available in FDA’s recall announcement.

The FDA and Octapharma have requested that customers quarantine any of the lots named by the recall and contact Octapharma customer service in order to return the affected drugs.