Onfi (generic clobazam) is a common epilepsy medication prescribed in the United States, which is primarily to treat a severe form of epilepsy called Lennox-Gastaut syndrome.

This condition typically develops in early childhood and persists through adulthood, causing patients to seek out various remedies, regardless of any side effects.

Unfortunately, Onfi has become infamous in the medical community for causing Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), an extreme allergic reaction, and the drug’s manufacturer, Lundbeck LLC, has been accused of negligence for allegedly failing to warn consumers of these side effects by not mentioning them on the drug’s warning label.

Recently, the U.S. Food and Drug Administration (FDA) released a public warning that Onfi may possibly cause Stevens Johnson Syndrome and Toxic Epidermal Necrolysis, and that these conditions could cause the patient permanent damage or fatal consequences. The FDA also warned that this drug could inflict these reactions during the first eight weeks of starting the medication, and that it is one of the most frequently reported drugs linked to SJS and TEN.

The FDA approved Lundbeck’s decision to update Onfi’s label to include warnings of potential skin disorders, as well as Onfi’s section in the Patient Medication Guide. Furthermore, the FDA’s case studies have observed that all reported Onfi SJS cases resulted in hospitalization, with one case resulting in blindness and one death.

Following the FDA’s warning, numerous patients have filed Onfi SJS lawsuits against Lundbeck, claiming that the company failed to protect them against Onfi’s severe side effects.

The announcement of Onfi’s association with SJS has concerned the medical community, because epilepsy patients have relied on the medication for over a decade. Doctors reportedly find themselves now reluctant to prescribe Onfi and often review alternative medications with patients. However, doctors warn concerned patients not to suddenly cease Onfi without consulting their physicians because it could cause additional side effects.

Overview of Stevens Johnson Syndrome

Stevens Johnson Syndrome can be fatal to patients if not treated in time. However, it is an extremely rare condition with only 300 cases diagnosed per year in the United States, which means that inexperienced physicians may either misdiagnose the patient’s symptoms or fail to recognize a problem.

It is important to note that SJS often starts out with flu-like symptoms, and is more likely to occur a drug if taken in conjunction with another medication.

Stevens Johnson Syndrome is often characterized by the red or purple skin lesions that can consume up to 30 percent of skin’s surface. Toxic Epidermal Necrolysis can take up as much 90 percent of the skin’s surface.

Additionally, the lesions often cause the infected skin to detach from the body and cause the patient to be open to further infection. Due to the nature of these injuries, patients are often treated in the burn units of hospitals. Skin grafts are often required to replenish lost skin. If not treated in time, SJS can cause permanent skin damage, blindness, and internal organ damage.

Due to the fact that SJS is such a rare reaction, many pharmaceutical companies do not include it or TEN on their drugs’ warning labels. Medical experts state that it is important for these companies to include any and all possible side effects, so patients are aware of the all risks attached to their medications. If companies choose not to do this, they could potentially be liable for various charges of negligence.