Statistics Indicate Onfi May Be Linked to SJS Syndrome

According to the medical statistics site MedFacts, there have been more than 100 different cases of Onfi-induced adverse side effects in patients, including Stevens Johnson Syndrome. MedFacts provides statistics and analytic reports regarding recent pharmaceutical issues that have been reported to the U.S. Food & Drug Administration (FDA). It provides risk assessment research for more than 20,000 different pharmaceutical products.

Between January 2004 and October 2012, five patients who had been taking Onfi reported Stevens Johnson Syndrome to the FDA. There were a total of 166 Onfi adverse side effects reported to the FDA during this time.

Often, the FDA only receives adverse drug reports from most severe cases, leading many medical experts to assume that these events are severely under-reported, and not representative of the true severity of the situation. In other words, scientists believe these cases are most likely occurring more often than presumed. While the number of cases indicated in the MedFacts statistics is small, it has still shown that Stevens Johnson Syndrome could possibly occur from Onfi, causing major concern for its manufacturer.Onfi (clobazam) is a benzodiazepine derivative that is manufactured by the European drug company Lundbeck Inc. It has been on the European market as an anticonvulsant drug since 1984. It was approved in the United States to treat Lennox-Gastaut Syndrome on Oct. 25, 2011. Onfi is not first-line treatment, and is not recommended for children who are between 3 months and 6 years old, unless there is a specific urgency. 

While most patients and physicians are excited about the potential new drug, there have been a number of injury reports of Stevens Johnson Syndrome and other severe reactions. While Stevens Johnson Syndrome is a fairly unusual event, it is an event the FDA and medical community take seriously.

As of now, Onfi’s warning label does not include Stevens Johnson Syndrome as a possible side effect, leading some patients to sue Lundbeck for negligence and inadequate warning. The FDA has not yet announced any investigative initiative regarding Onfi.

Overview of Stevens Johnson Syndrome 

Stevens Johnson Syndrome (SJS) is a severe allergic skin reaction, which is onset by one or more medications. SJS covers 10 percent to 30 percent in the lesions, and can potentially cause blindness and permanent scarring. Its latent form, Toxic Epidermal Necrolysis (TEN), is often fatal and showcases the final stages of Stevens Syndrome. In TEN, up to 90 percent of the body is covered in purple or reddish skin lesions.

SJS Syndrome typically starts with flu-like symptoms, and occurs within the first two weeks of starting a medication. Due to the nature of the lesions associated with SJS, patients are often treated the burn units of hospitals, requiring skin grafts as their skin detaches. Because SJS can be fatal, the patients should be sent in for immediate treatment.

Although there are only about 300 diagnoses of Stevens Johnson Syndrome per year in the United States, it is treated as very serious threat due to the severity of the condition’s side effects. The FDA strongly prefers that any drug found to possibly cause Stevens Johnson Syndrome to carry the indication on its warning label.

File an Onfi SJS Lawsuit Today

If you believe that you or a loved one have been the victim of an Onfi SJS injury, you have legal options. Please visit the Stevens Johnson Syndrome (SJS) & Toxic Epidermal Necrolysis (TEN) Class Action Lawsuit Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned SJS lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees. The SJS lawyers working this investigation do not get paid until you do.