Made from donated plasma

THURSDAY, Feb. 17 (HealthDay News) -- Corifact has been approved by the U.S. Food and Drug Administration to treat congenital Factor XIII deficiency, a rare genetic disorder that could cause life-threatening bleeding.

Corifact was approved as an orphan drug that's intended to treat a rare condition or disease. The FDA said it sanctioned the drug based on a study involving 14 people, including children, who had congenital Factor XIII deficiency. Reported side effects included allergic reactions, chills, fever, headache, and an increase in liver enzymes.

The drug is made from the pooled blood plasma of healthy donors. The FDA said people who use Corifact may wind up creating antibodies that make the drug ineffective, and warned doctors against administering doses higher than those listed on the product's label.

Corifact is made by the German pharmaceutical firm CSL Behring.

Featured In: CSL Behring