Anti-Seizure Drug Can Cause Serious Skin Reactions

The FDA has warned that the anti-seizure drug, clobazam, can cause rare but serious and life-threatening skin reactions, especially during the first 8 weeks of treatment. These skin reactions—including rash, blistering or peeling of the skin, sores in the mouth, and hives—are classified as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) and can occur at any time during treatment with clobozam. All known cases of SJS and TEN have resulted in hospitalization. One case resulted in blindness and another in death. Clobazam, a benzodiazepine medication, is often used in combination with other anti-seizure drugs to treat Lennox-Gastaut Syndrome, a severe form of epilepsy. Other benzodiazepine medications are not normally associated with serious skin reactions. “Health care professionals should discontinue use of [clobazam] and consider an alternate therapy at the first sign of rash, unless it is clearly not drug-related,“ the warning states. The Warnings and Precautions section of the drug’s label has been revised to include information about the serious skin reactions. –Michael Potts FDA Drug Safety Communication: FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has approved label changes. http://www.fda.gov/Drugs/DrugSafety/ucm377204.htm