An Onfi Stevens Johnson Syndrome safety warning was issued by the U.S. Food and Drug Administration this month, stating that the popular Lundbeck LLC anti-seizure drug has been linked with several cases of SJS and TEN.

Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are painful (and sometimes fatal) skin conditions that develop as allergic skin reactions. SJS and TEN can be set off by a whole host of prescription and over-the-counter medications, including the clobazam medication Onfi.

While Onfi SJS and TEN can occur at any point during treatment, most cases reported to the FDA involved patients developing Onfi SJS during the first eight weeks of treatment, usually when the Onfi prescription was discontinued and then picked up again.

According to the FDA safety warning, all the Onfi SJS and TEN cases reported to the agency have required hospitalization of the SJS/TEN victim. One patient was reportedly left blind because of the skin condition, and one patient reportedly died due to the trauma sustained from the SJS/TEN side effects.

While many of the Onfi SJS patients had been previously prescribed other drugs also known to cause SJS or TEN, the evidence suggested that Onfi was the cause of the allergic skin reaction.

Additionally, the FDA advised healthcare professionals to discontinue Onfi treatment “at the first sign of rash, unless the rash is clearly not drug-related. If signs or symptoms suggest a serious skin reaction, use of Onfi should not be resumed and alternative therapy should be considered.”

Should a patient develop Onfi SJS, the agency has also recommended that physicians use caution when switching patients from Onfi to another anti-epileptic medication, as there are several other seizure drugs also reported to cause SJS.

Many Onfi SJS and Onfi TEN victims have filed Onfi SJS lawsuits in the wake of contracting this painful and dangerous skin reaction.

Onfi Stevens Johnson Syndrome

Onfi is an anti-seizure medication manufactured by the Danish pharmaceutical company Lundbeck. The clobazam drug is used to treat Lennox-Gastaut syndrome, a condition that affects young children with severe epilepsy and seizures. While Onfi has had great success in helping these young patients control and manage their seizures, there have several reports of many consumers developing SJS or TEN as an Onfi side effect.

When a patient develops SJS or TEN, the individual’s topmost skin cells die and slough off, leaving the deeper layers and mucous membrane exposed and unprotected. When the sensitive mucous membrane 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, SJS/TEN victims require weeks or months of hospitalization. Some may even die, especially 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 consumers who allegedly developed SJS and TEN, many individuals and families have filed Onfi SJS lawsuits or joined Onfi SJS class action lawsuits.