FDA Alert: Epilepsy Drug Poses Risk for Serious Skin Reactions

The U.S. Food and Drug Administration warns that treatment with the antiepileptic clobazam (CLB; trade name Onfi) can cause potentially fatal cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), especially during the first 8 weeks of treatment. The agency has approved changes to the drug's label and medication guide to describe these risks.

Worldwide, 20 cases of SJS or TEN linked to CLB have been reported, including one fatality and one case of blindness; five of the six U.S. cases involved children.

The agency advises clinicians to “discontinue use of Onfi and consider an alternate therapy at the first sign of rash, unless it is clearly not drug-related.”