FDA Warns of Serious Skin Reactions With Onfi; Approves Label Changes

The Food and Drug Administration Dec. 3 said that the anti-seizure drug Onfi (clobazam tablets) can cause rare but serious skin reactions that may result in permanent harm and death.

Onfi is a benzodiazepine medication used in combination with other medicines to treat seizures associated with a severe form of epilepsy called Lennox-Gastaut Syndrome. The drug is manufactured by Winchester, Ky.-based Catalent Pharma Solutions LLC for Deerfield, Ill.-based Lundbeck Inc.

These rare but serious skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during Onfi treatment, the agency said. However, the likelihood of ...