HOBOKEN, N.J. — The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.
Octapharma USA said Octagam (immune globulin intravenous [human]) 5% would be available for distribution in a few weeks. The company voluntarily withdrew selected lots of the drug in August 2010 when a number of patients using it experienced thromboembolic events, or TEEs, in which blood clots form in arteries and veins, break loose and are then carried by the bloodstream to block another blood vessel. Octapharma USA said the FDA has observed that a number of similar drugs can cause similar problems due to a blood-clotting factor called activated factor XI.
The company said it worked with the FDA's Center for Biologics Evaluation and Research to develop and validate a scientific means of measuring and minimizing the amount of activated factor XI during the manufacturing process and in the finished product in order to prevent TEEs in the future.
"We are extremely pleased that the FDA has authorized the market return of Octacam 5%," Octapharma USA president Flemming Nielsen said. "Our collaboration with the FDA over the last year has enhanced awareness of the industrywide concerns regarding procoagulant activity and TEEs."