Onfi is one of the most popular antiseizure medications in the United States, treating millions of patients with Lennox-Gastaut Syndrome, and other severe forms of epilepsy. However, Onfi has also been the subject of numerous product liability lawsuits due to one of its severe side effects, Stevens Johnson Syndrome (SJS).

In a recent statement made by the U.S. Food and Drug Administration (FDA) on Dec. 3, 2013, the agency warned patients and the medical community of the risk of Onfi skin reactions. These reactions included the severe allergic reactions of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (TEN), which have been reported to occur in the United States and other countries after patients used Onfi. The FDA went on further to say that children were just as vulnerable to this reaction as adults.

An estimated 300 cases of Stevens Johnson Syndrome are diagnosed per year in the United States, with many of them being reportedly caused by Onfi. Despite its popularity, Onfi was only recently approved to go to market by the FDA in 2011. It is proudly manufactured by the European drug company, Lundbeck, garnering millions for the company each year. However, many patients allege that Lundbeck had been more concerned with Onfi’s profit values, rather than the safety of their customers. Additionally, it has also been alleged that Lundbeck had not adequately tested the drug before releasing it, and did not sufficiently research the drug’s possible side effects.

While Lundbeck has admitted to no wrongdoing at this point, numerous former Onfi patients have taken legal action against the company. At this point, at least 30 cases of Onfi SJS have been identified worldwide, impacting at least five children in the United States. Many patients have stated that if they had known about the risks of Stevens Johnson Syndrome, they never would have taken Onfi.

Overview of Stevens Johnson Syndrome

As mentioned before, Stevens Johnson Syndrome is a rare and extreme allergic skin reaction that is specifically caused by an adverse reaction to medication. It is infamously characterized by the red or purple skin lesions that are left on the body, which then cause the infected skin areas to detach. The patient’s mucous membranes, like the eyes and nose, also swell from the reaction and can cause side effects such as damaged vision. However, the most dangerous SJS symptoms are perhaps when the throat starts to close up, and when internal organs are damaged. Stevens Johnson Syndrome can be fatal if not diagnosed in a timely manner, and will often leave permanent skin scarring even if treated quickly. Its more severe cousin, Toxic Epidermal Necrolysis, is essentially the same reaction as SJS but with much quicker progression and skin lesions covering up to 90 percent of the body. In comparison, SJS can cover up to 30 percent of the skin.

Even though early diagnosis would prevent many further complications of SJS and TEN, it is often not the case as many physicians do not initially recognize the condition when patients report their symptoms. In being a very rare condition, not many physicians have encountered it and if SJS is not mentioned on the drug’s warning label, then physicians do not know to look for it. For this reason, it is vital for pharmaceutical companies to mention SJS on their drugs’ labels in order to prevent any unnecessary SJS casualties.

Experts state that if SJS does occur in patients, it will be within the first two to eight weeks of starting a medication, and will begin with flu-like symptoms. Additionally, SJS is more likely if a patient is taking more than one medication at the time they start a new drug. Due to the nature of SJS symptoms, patients are often treated in the burn unit of hospitals because patients will often need skin grafts.