The U.S. Food and Drug Administration (FDA) is warning the public that the anti-seizure drug clobazam—sold under the brand name Onfi—might cause severe, deadly skin reactions.
What Is Onfi and What Is It Prescribed For?
Onfi is the brand name for the drug clobazam. Made and sold by Danish pharmaceutical company Lundbeck LLC, this prescription medication is used along with other anti-seizure drugs to treat Lennox-Gastaut syndrome, a severe form of epilepsy that affects children. Although clobazam has been marketed outside the United States for more than 40 years, the FDA approved the drug for patients two years and older in October 2011 as an oral tablet and then as an oral suspension in December 2012. From its initial approval in 2011 until September 2013, 31,000 patients obtained Onfi prescriptions.
Like other benzodiazepine drugs, Onfi’s mechanism of action is not completely understood. It is thought to bind with neurons that produce the neurotransmitter GABA, facilitating electrical communication in the brain.
Onfi Might Cause Serious Skin-Related Side Effects
On December 3, 2013, the FDA issued a drug safety communication warning that Onfi can cause serious skin conditions in users. Symptoms of skin problems include:
- Sores in the mouth
The FDA emphasized that Onfi use might cause a severe skin reaction: toxic epidermal necrolysis (TEN). A more severe form of Stevens-Johnson syndrome, TEN is a frequently fatal condition that occurs when the top layer of the skin (the epidermis) separates from the next layer (the dermis) and then dies. The disease has a high mortality rate; 30-40 percent of victims die due to subsequent bacterial or fungal infections.
The FDA based its Onfi warning on adverse event reports it received from 20 patients who developed TEN. Six of the patients were in the U.S. and another 14 were in foreign countries. Five of the six American patients were children. All patients required hospitalization. One was blinded, and another died.
RLG’s Onfi Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an Onfi lawsuit on your behalf if necessary. RLG will also keep you up to date on any Onfi class action lawsuits, additional FDA Onfi warnings, and Onfi FDA recall announcements. If you or a loved one has taken Onfi, and you believe it caused an injury, contact RLG today.