At the end of 2013, the U.S. Food and Drug Administration (FDA) issued a nationwide drug and safety communication to consumers, physicians, and other healthcare professionals regarding the possible Toxic Epidermal Necrolysis and Stevens Johnson Syndrome side effects associated with the use of Onfi (or clobazam), a popular anti-seizure medication.

Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are serious skin reactions that some people develop after taking some over-the-counter and prescription medications.

One that has recently come under fire within the United States and abroad for allegedly causing SJS and TEN reactions is Onfi, a medication used to treat Lennox-Gastaut and other seizure conditions.

Onfi originally received FDA approval as a treatment for Lennox-Gastaut in 2011 and was thought to be a safe medication for children diagnosed with this severe form of epilepsy that tends to affect patients as young as 2 years of age.

However, according to FDA reports, the agency has identified 20 different cases of Onfi SJS and TEN that were reported by healthcare professionals to the Adverse Event Reporting System database.

The FDA data states that since 2011, about 31,000 patients have been prescribed clobazam, meaning that for about every 10,000 users, six are statistically likely to contract Onfi SJS. The agency recognizes that this data is based on submitted medical reports, meaning the actual Onfi SJS risk could be higher than currently reported.

Of the reported Onfi SJS cases, two deaths were reported as being allegedly caused by Onfi use. Additionally, one case resulted in the patient becoming blind because of the sustained SJS side effects. All reported Onfi SJS cases required that the affected individual be hospitalized for treatment and monitoring. One patient reportedly developed TEN, the more advanced and deadlier form of SJS.

According to the Onfi SJS reports, many patients exhibited improved health and reduction in SJS side effects as soon as they were taken off clobazam treatment.

Onfi Stevens Johnson Syndrome Side Effects

Onfi is an anti-seizure medication that is manufactured by Lundbeck, a Denmark-based pharmaceutical company. While Onfi has been very successful in helping young Lennox-Gastaut patients control and manage their seizures, there have been several reports within the U.S. and internationally of children developing Onfi SJS or TEN after taking the Lundbeck drug.

When an individual develops Onfi SJS, the individual’s topmost layer of skin dies and falls off the body, leaving more sensitive skin layers and the mucous membrane exposed to infection and blistering.

Because of the extreme pain experienced by Onfi SJS victims and care needed to recover and revert to normal health, many patients are required to endure weeks or even months of hospitalization. Some may even die if the burn-like skin reaction spreads to over 30 percent of their body, causing internal as well as external damage to skin cells.

As a result of the pain and suffering experienced by Onfi SJS victims, many individuals and families have filed Onfi SJS lawsuits or joined Onfi SJS class action lawsuits, seeking personal damages and injunctive relief from Lundbeck.