Onfi (clobazam) has been linked to several cases of Stevens Johnson Syndrome (SJS), including that of an 11-year-old boy whose parents filed an Onfi SJS lawsuit after the boy allegedly suffered a devastating reaction to the anti-seizure medication.

Plaintiffs Madeline E. and Rogelio E. claim that their son was prescribed Onfi off-label for epilepsy. Onfi was approved by the U.S. Food and Drug Administration (FDA) in 2001 to treat Lennox-Gastaut Syndrome (LGS), a severe form of epilepsy.

The Onfi SJS lawsuit claims that Lundbeck Pharmaceuticals, the drug’s manufacturer, encouraged off-label use of Onfi. The plaintiff did not have LGS but was given Onfi allegedly due to Lundbeck’s marketing. The child allegedly then developed SJS and the more severe toxic epidermal necrolysis (TEN).

SJS is a severe skin disorder that essentially causes the skin to burn and  blister from the inside out. It begins with a rash, but develops into blisters which can cause the skin to peel off in the infected areas.

SJS on its own can take weeks to months to recover from and can leave scars on the body in addition to other complications. Most SJS cases are not fatal.

However, when the infected skin covers more than 40 percent of the body, the diagnosis changes to TEN. TEN can cause the skin to peel off in sheets, leaving the body exposed to secondary infections including sepsis (blood infection). TEN has a mortality rate of 40 percent. It is common for TEN patients to be treated in a burn ward due to the similarities with burns.

SJS and TEN commonly begin on the skin, but they tend to spread to mucous membranes such as the mouth, eyes, and genital areas.

Onfi SJS Lawsuit

The boy allegedly developed TEN as a direct result of taking Onfi. In the child’s case, a large portion of skin on his body blistered, burned, and fell off, “including the inside and outside of his mouth, throat, and genital areas” according to the Onfi SJS lawsuit. He was in the hospital for a month and recovered. However, he was left with permanent scars and psychological injuries, according to the Onfi side effects lawsuit.

Several months after this occurred, the FDA changed the Onfi warning labels to include SJS risks. The Onfi SJS lawsuit claims that Lundbeck was aware of the SJS risks long before the FDA warning and before the plaintiff’s reaction.

More than 30,000 patients have taken Onfi for LGS as well as for off-label uses since its approval in 2011. Since then, the FDA has observed an increase in SJS/TEN cases in Onfi users and changed the warning labels accordingly.

However, many individuals and families have filed Onfi SJS lawsuits against Lundbeck alleging off-label promotion, failure to warn, as well as defective design and manufacturing.