Aubagio Approved for Multiple Sclerosis
THURSDAY Sept. 13, 2012 -- Aubagio (teriflunomide) has been approved by the U.S. Food and Drug Administration to treat adults with relapsing forms of multiple sclerosis (MS).
MS is a chronic inflammatory disease that affects communication between the brain and other parts of the body. About twice as prevalent in women than men, it's among the most common causes of neurological disability in young adults, the FDA said in a news release.
The drug's label contains the FDA's most stringent black box warning, alerting doctors and patients to the possibility of deadly liver problems. Doctors are advised to perform blood tests of liver function before and during treatment, the agency said.
Aubagio's label also advises that the drug could harm a developing fetus. So, women of childbearing age must have a negative pregnancy test before beginning treatment and take effective birth control during treatment, the FDA said.
More common but less severe adverse reactions to the drug have included diarrhea, nausea and hair loss.
Aubagio, which is taken as a tablet once a day, is produced by Sanofi Aventis, based in Bridgewater, N.J.
Medline Plus has more about multiple sclerosis.
Posted: September 2012