In February 2012, an 8-year-old boy in New Braunfels, Texas, was prescribed a new medication to treat his seizure disorder. After taking the new prescription, Levi G. suffered a rare allergic skin reaction known as Stevens Johnson Syndrome, as reported by San Antonio news source KENS5 on Feb. 10.

During the process of fighting SJS, the boy’s body started to burn from the inside out, causing him to lose 85% of his skin and had to spend six months at a Galveston hospital.

Levi, now 11, is still suffering the side effects of Stevens Johnson Syndrome, including seared tear ducts and scratched corneas and is considered legally blind, with no sight left in his left eye and just a small percentage of vision in his right eye.

Seizure Medications Linked to Stevens Johnson Syndrome

Dozens of over-the-counter and prescription drugs have been linked to causing Stevens Johnson Syndrome. Anti-seizure medications such as Onfi and Lamictal are among the drugs most often associated with serious skin reactions including Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

What Is Stevens Johnson Syndrome?

Stevens Johnson Syndrome (SJS) is a potentially life-threatening skin reaction that is known to be caused by several different medications, like the seizure medication, Onfi. 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 Onfi SJS and TEN usually require inpatient care at a hospital burn unit, and it can result in permanent blindness, organ failure and death. While anyone can be diagnosed with SJS, it is more common in children and people of Asian or African-American descent.

Onfi SJS Warnings

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 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.

On Dec. 3, 2013, almost 2 years after Levi developed SJS and was hospitalized, the FDA announced that it was updating the Onfi drug labels and medication guides to include warnings about the risk of Onfi side effects, including rare but dangerous skin problems. It is unknown whether Levi is among those cases of skin problems from Onfi that the FDA was aware of when warnings were issued.

Manufacturer Failed to List Onfi SJS Side Effects

Seizure medications, like Onfi, can trigger rare skin reactions that are extremely dangerous, painful, and disfiguring, and can lead not only to life-threatening infections, but also organ damage, blindness, and death.

Pharmaceutical companies are obligated to follow strict laws when it comes to prescription drugs they manufacture for consumer use. According to the FDA, five of the reported Onfi SJS cases in the United States were in children (the drug is approved for use in children two years of age and older).

As a result, the FDA required Onfi’s manufacturer, Lundback, to amend its labels to explicitly list the possibility of SJS and TEN. Since this warning was not previously included in Onfi’s labels, patients who suffered from either or both of these conditions may be able to file an Onfi lawsuit against Lundback.