Anti-Seizure Drug Linked to Stevens Johnson Syndrome: FDA

December 5, 2013, 8:00AM. By Gordon Gibb

Washington, DCOn Tuesday, the US Food and Drug Administration (FDA) released its latest safety warning with regard to a medication and a potential link to Stevens Johnson Syndrome, the rare but debilitating skin condition that can be likened to serious burns.

The drug at issue is the anti-seizure medication ONFI (clobazam), manufactured by Lundbeck, the Danish pharmaceutical company. The potential for blisters and skin rash is duly listed on the product web page for ONFI, but Stevens Johnson Syndrome is not specifically referenced, and the FDA has since issued the safety release and is mandating updates to the prescribing information for the product.

With ONFI, according to the FDA, Stevens Johnson Syndrome symptoms can occur at any time, but are more likely than not to surface within the first eight weeks of treatment, or if and when the treatment is stopped, then re-started.

Of the Stevens Johnson Syndrome skin disease cases reported to the FDA’s adverse event reporting system, all patients were hospitalized. One case resulted in blindness and another individual died.

The FDA did acknowledge that some patients received previous or co-treatment with another drug also thought to increase the risk of SJS rash and related skin disease, but according to evidence cited by the FDA (but not specified), it appeared that ONFI was the likely cause of SJS in those patients..

Stevens Johnson Syndrome and its more serious cousin, Toxic Epidermal Necrolysis (TEN), appear to be an allergic reaction to various medications. It is not known why some individuals react badly to medication and not others. Nonetheless, various Stevens Johnson Syndrome lawsuits have alleged that manufacturers have not been forthcoming with the potential for SJS and TENS. One well-known pain reliever carried SJS warnings on its prescription version, but carried no such warnings on its over-the-counter (OTC) version.

SJS can begin as a Stevens Johnson Syndrome rash, then progress rapidly to blisters over much of the body. The interior of the mouth can also be affected, as are the eyes. Cases of blindness have been reported. Patients, whose eyesight recovers, have often been left with permanent light sensitivity.

Stevens Johnson Syndrome symptoms have been likened, in some reports, to the body burning from the inside out. Most patients are treated in burn units after hospitalization, as SJS and TEN symptoms are similar to that of burns. Skin has been known to slough away in sheets, and SJS patents - from adults to children - can become very, very ill. Those who survive - and not all do - are often permanently scarred.

ONFI is a benzodiazepine medication used in combination with other medicines to treat seizures associated with a severe form of epilepsy called Lennox-Gastaut Syndrome. According to Monthly Prescribing Reference (MPR; 12/3/13), ONFI is indicated for adults and children over two years of age. Serious skin reactions such as SJS have not generally been associated with other benzodiazepines, according to the FDA.

According to the official ONFI web page, “Serious skin reactions have been seen when ONFI is taken with other medicines and may require stopping its use. A serious skin reaction can happen at any time during your treatment with ONFI. Call your healthcare provider immediately if you have skin blisters, peeling rash, sores in the mouth, hives or any other allergic reaction.”

There is no specific reference to Stevens Johnson Syndrome as of December 4, 2013. It is not known if this omission in specific reference to SJS would prompt patients to contact one of any number of Stevens Johnson Syndrome lawyers fielding SJS cases…