Onfi (clobazam) is an anti-seizure prescription drug, available in oral tablets or oral suspension, marketed by Lundbeck, Inc. It is used for the adjunctive treatment (added to other anti-seizure medications) of Lennox-Gastaut Syndrome (LGS), in patients 2 years of age and older. LGS is a severe form of childhood epilepsy, characterized by multiple seizure types, as well as abnormal development. It generally has an onset between the ages of 3 and 8 years, and can persist into adulthood. Since the drug was first marketed in October 2011, it has been associated with adverse reactions, including somnolence or sedation, physical and psychological dependence, and suicidal behavior and ideation.
On December 3, 2013, the FDA warned the public that Onfi can cause serious skin reactions that may result in permanent harm and death. These skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during Onfi treatment. The likelihood of serious skin reactions is greater during the first 8 weeks of treatment or when Onfi is stopped and then resumed. All SJS/TEN cases identified by the FDA resulted in hospitalization, with one case resulting in blindness, and at least one death. Many of the cases involved children. Symptoms of SJS/TEN include rash, blistering or peeling of the skin, sores in the mouth or hives.
As a result of these serious skin reactions caused by Onfi, the FDA has required a revised drug label that describes the risk of these serious skin reactions. The previous drug label provided by the manufacturer of Onfi did not disclose these serious skin reactions.
If you or your child has suffered serious skin reactions while taking Onfi, you may be entitled to significant compensation. The lawyers at Keller, Fishback & Jackson have years of experience representing individuals in litigation against large pharmaceutical and medical device manufacturers. Time may be limited to file a lawsuit. Contact us today for a free legal consultation.