Back in 2013, the U.S. Food and Drug Administration demanded changes to the labeling of a relatively common seizure drug Onfi to reflect new information about a possible life-threatening Onfi side effect.

Onfi (clobazam) is a relatively common seizure drug, sometimes sold under the drug names Frisium and Urbanol. Onfi is approved to treat epilepsy and several other seizure disorders, and has also been approved as a treatment to reduce anxiety in people with some psychiatric disorders. This is not uncommon, as many drugs that treat epilepsy have been found to work as anti-anxiety or antidepressant drugs and vice-versa. However, evidence has surfaced that Onfi may trigger a life-threatening autoimmune reaction called Stevens Johnson Syndrome or Onfi SJS.

Background on Stevens Johnson Syndrome

Stevens Johnson Syndrome is a critical drug reaction which causes the immune system to go haywire and attack the patient’s own skin, the same way the body would usually attack bacteria, viruses, or other parasites. Most of the early SJS symptoms closely resemble various viral diseases,which often causes doctors to misdiagnose patients with the first SJS symptoms with other conditions. Stevens Johnson Syndrome starts out with generalized flu-like symptoms, including muscle aches, chills, fever, and other symptoms seen in many common diseases. Then, the patients develop a painful skin rash. However, the SJS rash could still be mistaken for other diseases, as it resembles shingles, chickenpox, or even an unusual case of herpes.

SJS symptoms escalate beyond the painful SJS rash seen in the early stages of Stevens Johnson Syndrome. Patients develop sores, blisters and ulcers all over their skin, including their eyes and the insides of the mouths. Sometimes, the internal organs can be damaged as well, causing fluid to build up in the lung. Damage to the eyes can cause blindness and most patients are left with burn-like scars all over their body.

Many questions remain about Stevens Johnson Syndrome, but one of the few things that medical science is quite sure of is that the majority of SJS cases can be linked to an exposure to certain drugs. New FDA research indicates that Onfi may be among the drugs that can cause Stevens Johnson Syndrome.

Onfi SJS Warnings

On Dec. 3,2013, the FDA issued a Drug Safety Communication advising the public that the agency had received rare but serious reports of Stevens Johnson Syndrome and a related disorder called Toxic Epidermal Necrolysis or TEN tied to Onfi use. All of the cases of SJS reported to the FDA after taking Onfi had required hospitalization. One Onfi SJS patient survived with permanent blindness and one death was reported to the FDA.

The FDA did not advise patients to stop taking Onfi, but did suggest that they seek emergency medical care if they experienced a rash while taking Onfi. Though Onfi SJS is life-threatening, it is never a good idea to stop taking a seizure drug suddenly. Emergency medical supervision is critical for anyone with SJS, especially one who may be at risk for seizures.

SJS lawsuits have been filed against drug makers by patients who develop SJS from drugs like Onfi. These Onfi lawsuits allege that drug makers have not done enough to protect the public from the risk of SJS as caused by Onfi and other drugs. Other SJS lawsuits have been filed against hospitals and medical centers, alleging doctors fail to recognize and treat SJS quickly, leading to critical lapses in treatment.