A settlement was reportedly reached in an Onfi SJS lawsuit filed on behalf of a young boy who allegedly experienced dangerous Onfi side effects. The Onfi SJS lawsuit was dismissed on Dec. 19.

The Onfi SJS lawsuit was filed after an 11-year-old boy developed Stevens Johnson Syndrome, a severe skin condition, allegedly after taking Onfi. Onfi is a medication used to treat a severe form of epilepsy called Lennox-Gastaut Syndrome. The son of plaintiffs Madeline E. and Rogelio E. was prescribed Onfi off-label for a different epilepsy condition.

Thousands of individuals have been prescribed Onfi for both on-label and off-label purposes. Lundbeck, the drug manufacturer, has been accused of encouraging off-label use, which has allegedly led to several cases of Onfi SJS.

Stevens Johnson Syndrome

SJS is an autoimmune disease that causes the body to attack the skin. It is almost always caused by a drug reaction. It begins with flu-like symptoms but develops into a painful rash.

This rash is often the first sign that the condition is serious. SJS then causes the skin to blister and essentially burn off from the inside out.

Many patients experience skin loss in the infected areas of the body. SJS can affect up to 30 percent of the body including mucous membranes such as the nose, mouth, and eyes.

SJS may take anywhere from two weeks to two months to recover from. SJS patients are often left with permanent SJS side effects such as scars, organ failure, and blindness. About every one in 20 SJS cases are fatal.

It is when the blisters cover more than 40 percent of the body that the condition elevates to Toxic Epidermal Necrolysis (TEN). TEN may affect anywhere between 40 and 90 percent of the body. TEN can cause the body to lose skin in large sheets. TEN patients are generally treated in a hospital’s burn ward due to the severity of skin damage. Many TEN patients develop secondary infections or sepsis because of lost skin, and 40 percent of TEN cases are fatal.

Onfi SJS Lawsuits

The child named in the Onfi SJS lawsuit developed TEN after using Onfi. According to the Onfi SJS lawsuit, the boy experienced large skin loss from severe blistering, including the inside and outside of his mouth, throat, and genital areas. While he recovered, he was left with scars and psychological injuries.

The FDA later told Lundbeck to change the warning label to include SJS side effects, but this was not until many users had allegedly developed the severe skin condition after Onfi use. Numerous Onfi SJS lawsuits were filed that accused Lundbeck of off-label promotion, failure to warn, and defective design and manufacturing.

This Onfi SJS lawsuit reportedly resulted in a settlement from Lundbeck.