Patients dealing with seizures often turn to their medications to maintain a normal life, but the dangers associated with Onfi, a brand name for clobazam, have recently been discovered by the Food and Drug Administration (FDA). Clobazam is a popular anti-seizure drug, and its adverse effects are distinctive among other drugs in the benzodiazepine class.  The most harmful complication it is known for is Stevens-Johnson Syndrome(SJS), which was the subject of a report released by the FDA in December 2013.

Clobazam is a common medication prescribed to patients suffering from seizures. The drug acts on gamma-aminobutyric acid (GABA) receptors in the brain, which are responsible for regulating neural activity in the nervous system. Specifically, clobazam is an agonist, so it encourages the stimulation of the receptors. Because seizures are often caused by a lack of GABA activity, clobazam is an effective option in the treatment of seizures.  Furthermore, as a member of the benzodiazepine class of drugs, it can also help with anxiety and epilepsy.

After reviewing all of the available literature and case reports, though, the FDA found an increased risk for serious skin conditions linked to clobazam. No other benzodiazepine produces significant skin problems, so this was a concern. Among the dangers associated with Onfi, SJS is the most severe as it can be deadly. SJS is normally due to an unchecked immune response, caused by the presence of some medications, such as clobazam. SJS typically presents a fever, fatigue and a sore throat first, so it is normally misdiagnosed initially. Before long, though, lesions and ulcers begin to appear on mucus membranes throughout the body, including mouth and lips.  The anus and genitalia may also be affected. At its apex, SJS causes a rash of lesions on the face, arms, legs and torso to appear.

Mass skin cell death accompanies SJS, and it can cause the epidermis to separate from the underlying dermis. This can result in extreme damage to the skin, enough to leave permanent scars and skin discoloration. However, secondary infections and organ failure represent the real dangers associated with Onfi because the skin loses much of its ability to reject infection. If a person afflicted with SJS does not seek medical treatment immediately, they face a chance of permanent disability or death. Even with thorough medical attention, blindness and organ failure are possible outcomes of the disease. The risks of developing SJS while using clobazam is highest during the first eight weeks of treatment, and patients should be especially vigilant during this time. Doctors recommend a patient seek immediate medical attention if they develop a rash or blisters, particularly around the mouth. In light of the research surrounding clobazam, the FDA now requires the manufacturer, Lundbeck, to include a warning on the medication’s label.

Many people who have taken clobazam have been affected by SJS, including a person who was killed by the condition and another who was permanently blinded. Anyone who has taken clobazam and suffered from SJS or other serious complications may want to consider speaking to a drug injury attorney. Compensation attained through a successful claim can help deal with medical costs and other expenses.