Aubagio (teriflunomide) Multiple Sclerosis drug gains FDA approval

Prescription bottle - BSN

(Best Syndication News) - The US Food and Drug Administration (FDA) approved Aubagio (teriflunomide) to treat relapsing types of multiple sclerosis in adults. The treatment is a once-a-day tablet.

The clinical trial results showed around a 30 percent lower rate of relapse in multiple sclerosis patients taking Aubagio compared to a placebo. The side effects reported from Aubagio included diarrhea, abnormal liver test, nausea, and hair loss.

There will be a Boxed Warning that will notify the patient and the doctors about the possibility of liver problems, a risk of death, and a risk for birth defects. Because of liver problems, doctors are instructed to test the blood periodically and when starting Aubagio for liver function. The Boxed Warning also has been flagged for possibly causing fetal harm because of animal studies that demonstrated this problem. Women of childbearing age have to have a negative pregnancy test before starting Aubagio and they have to use a birth control during the treatment.

Aubagio is being manufactured by Bridgewater, N.J.-based Sanofi Aventis.

By: Marsha Quinn
Health Reporter

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