In January 2014, Health Canada (the Canadian version of the U.S. Food and Drug Administration) sent a letter warning consumers and medical professionals about a few new drugs linked to the development of a painful, and often fatal, skin reaction Stevens Johnson Syndrome, which most notably includes Onfi. This decision by another federal agency demonstrates the international concern that Onfi SJS poses.

Meanwhile in the United States, the FDA published a Drug Safety Communication regarding the possible Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) side effects associated with taking the anti-seizure medication Onfi a month prior to the Canadian warning, in December 2013.

In this Onfi SJS drug safety notice, the FDA identified 20 different cases of patients developing SJS and TEN directly related to their use of Onfi. Six of these Onfi SJS cases occurred within the United States, while the remaining 14 SJS and TEN cases linked to this Lundbeck anti-seizure medication occurred in other countries worldwide. Of the known U.S. Onfi SJS cases, five of them involved children developing this painful skin condition. And of the 20 Onfi SJS reactions recorded as of January 2014, one resulted in patient’s blindness and two others ended in death.

While an SJS and TEN reaction can occur at any time while taking Onfi, the FDA has noted that patients are most at risk of developing Onfi SJS during the first eight weeks of anti-seizure treatment, or when the drug treatment is stopped and then restarted.

Onfi Stevens Johnson Syndrome Side Effects

Onfi (also known as clobazam), is an anti-seizure medication that is manufactured by Lundbeck, a Danish pharmaceutical company. Onfi is commonly used and prescribed as a treatment for Lennox-Gastaut Syndrome, a difficult neurological condition that affects young children, causing them to experience severe epilepsy and seizures. While Onfi has been very successful in helping young Lennox-Gastaut patients control and manage their seizures, there have also been several medical reports of consumers developing Onfi side effect like SJS and TEN.

When an individual develops Onfi SJS or TEN, the individual’s topmost layer of skin dies and sloughs off, leaving the deeper skin layers and the mucous membrane exposed. When the sensitive mucous membrane becomes exposed to the elements, it can become infected and eventually blister.

Because of the extreme pain experienced by SJS victims and care needed to recover, Onfi SJS and TEN victims require weeks or even months of hospitalization. Some may even if the burn-like skin reaction spreads to over 30 percent of their body.

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.