Onfi, an anti-seizure drug, has been linked to Stevens Johnson Syndrome (SJS), a life-threatening skin condition that can develop at any time in both children and adult patients.

The U.S. Food and Drug Administration (FDA) recently issued a Drug Safety Communication warning patients and doctors of the rare but extremely serious health risks associated with Onfi.

Onfi is an epileptic medication used in combination with other drugs to treat seizures caused by a severe form of epilepsy known as Lennox-Gastaut Syndrome.

Understanding Stevens Johnson Syndrome

The FDA approved Onfi for public use in 2011 to treat seizures for individuals with Lennox-Gastaut Syndrome. However, there have been numerous reports of Onfi patients being diagnosed with Stevens Johnson Syndrome (SJS) and its more severe form, toxic epidermal necrolysis (TEN), and at least one of which resulted in death.

SJS, as it’s known, is a severe skin disorder. Onfi SJS symptoms include flu-like symptoms such as fever, cough, headache, and sore throat. However, the symptoms intensify into a very painful skin rash — much like a third-degree burn — that eventually transform into blisters all over the body.

SJS is a medical emergency that involves a painful and spreading rash that eventually kills the top layer of a person’s skin. People with SJS can die from complications such as infection, sepsis, blindness and organ damage.

Those suffering from SJS need hospitalization to control the outbreak, prevent bacterial infections and other life-threatening complications. Many are admitted to burn or intensive care units for treatment and monitoring. Recovery takes weeks and, in some cases, months depending on the severity of the skin outbreak.

In extreme cases, toxic epidermal necrolysis, or TEN, can occur. TEN is a severe form of SJS that causes the top layer of the skin to detach from the lower skin layers and requires hospitalization and treatment in intensive care or burn units. Individuals are vulnerable to heightened fungal and bacterial infections, which can lead to permanent vision loss, asthma and even death.

Onfi SJS Lawsuits

Pharmaceutical companies are obligated to follow strict laws and protocols when it comes to prescription drugs or products they manufacture for consumer use. Companies who fail to abide by these laws could be civilly liable to those harmed by their product or drug.

According to the FDA, five of the reported Onfi SJS/TEN 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 of these conditions may be able to file an Onfi lawsuit against Lundback.