THURSDAY, Feb. 17, 2011 (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.
People born with the disorder do not make enough Factor XIII, a clotting ingredient found in most people's blood, the FDA said in a news release. The condition may cause soft-tissue bruising, fatal bleeding inside the head, and in newborns, umbilical cord 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.
The FDA has more about this approval.