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Onfi Lawsuit Filed for Stevens-Johnson Syndrome (SJS)

Onfi Lawsuit Filed for Stevens-Johnson Syndrome (SJS)

February 24, 2014 — A lawsuit has been filed on behalf of an 11 year-old boy who suffered severe physical disfigurement and psychological trauma after he was prescribed the anti-seizure drug Onfi (clobazam) and developed Stevens-Johnson Syndrome (SJS), a life-threatening skin reaction.

Madeline and Rogelio Escareno filed the Onfi lawsuit on behalf of their son, Antonio. They allege that Lundbeck, the manufacturer, was negligent for failing to warn about the risk of SJS and aggressively promoting Onfi “off-label” (for uses not approved by the FDA).

Onfi is only approved to treat Lennox-Gastault Syndrome, a rare type of epilepsy that affects less than 200,000 Americans per year. Lawyers allege that Lundbeck made hundreds of millions of dollars by marketing Onfi for all types of seizures. As a result, children like Antonio who did not have Lennox-Gastault Syndrome were exposed to an increased risk of side effects like SJS.

According to the complaint:

“Antonio’s SJS reaction resulted in the blistering, burning, sloughing and peeling of the skin from a large portion of his body, including the inside and outside of his mouth, throat and genital areas, and required him to remain in Cook Children’s Medical Center in Fort Worth for approximately one month in March of 2013. Antonio’s SJS reaction was so severe that he lost much of his skin, his hair and fingernails. He is permanently scarred and psychologically traumatized.”

The U.S. Food and Drug Administration (FDA) published a Drug Safety Communication for Onfi in December 2013, after identifying 20 cases of Stevens-Johnson Syndrome (SJS). All of the cases resulted in hospitalization, with one case resulting in blindness and another case resulting in death.

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