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Anti-Seizure Drug Can Cause Serious Skin Reactions, FDA Warns

Filed December 4th, 2013 Laurie

The U.S. Food and Drug Administration (FDA) issued a warning on December 2 concerning the anti-seizure medication Onfi (clobazam). The agency said the drug can cause serious skin reactions that can result in permanent harm and death.

According to, Onfi is a benzodiazepine used in combination with other drugs to treat seizures in patients with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems. It was approved by the FDA in 2011 as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older.

The agency warned that patients taking Onfi should seek immediate medical treatment if they develop a rash, blistering or peeling of the skin, sores in the mouth, or hives. These serious medical conditions, known as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during Onfi treatment, but the likelihood is greater during the first eight weeks of or when Onfi is stopped and restarted.

All instances of SJS and TEN in the FDA case series resulted in hospitalization. One patient was blinded, and one died.

According to the FDA warning, patients should not stop taking Onfi without first talking to their healthcare provider, as serious withdrawal symptoms have been associated with the drug, including nonstop seizures, hallucinations, shaking, nervousness, and stomach or muscle cramps.

The FDA said in the warning that it had called for and approved a revision of Onfi’s label as well as an update in the Warnings and Precautions section.

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