-- Scott Roberts
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
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
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
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
Corifact is made by the German pharmaceutical firm CSL
The FDA has more about
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