The parents of an eleven year old boy have filed a product liability lawsuit against the makers of Onfi, alleging that side effects of the anti-seizure caused their child to suffer a serious skin reaction, known as Stevens-Johnson syndrome (SJS), which resulted in the loss of much of his skin, hair and fingernails.
The complaint (PDF) was filed last month in the U.S. District Court for the Northern District of Texas, by the parents of Antonio Escareno, who has allegedly been left permanently disfigured and traumatized by the skin problems following Onfi use.
According to the lawsuit filed by Madeline and Rogelio Escareno, Antonio received an off-label prescription of Onfi for treatment of epilepsy. He subsequently developed SJS, which later progressed to the more severe and deadly form of the skin reaction, known as toxic epidermal necrolysis (TEN).
As a result of side effects of Onfi, the lawsuit claims that the child’s skin began to blister, burn and then fall off “from a large portion of his body, including the inside and outside of his mouth, throat and genital areas,” according to the complaint.
The boy was hospitalized for about a month in Cook Children’s Medical Center in Fort Worth in March 2013, and has been left with permanent scars and psychological injuries.
The lawsuit notes that at the time Antonio was injured, the makers of the anti-seizure drug failed to provide adequate warnings for the medical community or patients about the risks of Onfi skin reactions. It was not until much later that year that the FDA announced a label warning update, but the family claims that Lundbeck Pharmaceuticals knew about the potential Onfi side effects for years and withheld information about the risks.
Onfi Stevens-Johnson Syndrome (SJS) Warnings
On December 3, 2013, months after Antonio was injured and hospitalized, the FDA announced that it was updating the Onfi drug labels and medication guides to include warnings about the risk of the rare but dangerous skin problems.
The agency issued an Onfi drug safety communication, warning patients to seek immediate medical treatment if they develop a rash, blistering, or peeling of skin, sores in the moth or hives after using the medication.
Stevens-Johnson Syndrome (SJS) is a serious skin reaction that is known to be caused by several different medications. It involves burns to the skin that develop from the inside out, producing blisters, severe rashes, and potentially causing the skin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is typically referred to as Toxic Epidermal Necrolysis (TEN).
Treatment for SJS and TEN usually require inpatient care at a hospital Burn Unit, and it can result in permanent blindness, organ failure and death.
Onfi (clobazam) was approved in October 2011 for the treatment of patients two years or older who suffer from Lennox-Gastaut Syndrome (LGS), a severe form of epilepsy. Since that time, about 31,000 patients have taken the drug in the United States and the the FDA has become aware of at least 20 cases of SJS/TEN worldwide, including six cases in the U.S. Five of the six cases in this country involved children. It is unknown whether Antonio Escareno is among those cases of skin problems from Onfi that the FDA was aware of when warnings were issued in December 2013.
In addition to claims for failure to warn, the lawsuit also alleges that Lundbeck illegally promoted Onfi for uses that were not approved by the FDA. Antonio was prescribed the drug for his epilepsy, even though he was not diagnosed as having LGS. According to the complaint, Lundbeck marketed Onfi for a much broader range of seizure treatments.
While doctors are allowed to prescribe a drug for any reason they see fit, it is illegal for drug manufacturers to promote their drugs for uses other than those approved by the FDA.
The Escareno’s Onfi lawsuit accuses Lundbeck of off-label promotion, failure to warn, Defective design and manufacturing, fraud, breach of warranty, negligence, and gross negligence. They seek damages for physical and mental pain and suffering, impairment and disability, mental anguish, medical expenses, loss of enjoyment of life, and also ask the court to award punitive damages on the company as well.