The FDA has warned that the anti-seizure drug Onfi (clobazam) can cause Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), which are life-threatening skin conditions that require hospitalization and emergency treatment.

The anti-seizure drug Onfi (clobazam) may cause serious injury and even death, warns the U.S. Food and Drug Administration in a safety alert. The medication was originally approved by the FDA to treat a severe form of epilepsy in adults and in children aged 2 and older.

The recent drug safety communication states that Onfi has been associated with serious skin reactions including Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which can develop anytime during Onfi exposure.

What is Onfi?

Onfi (clobazam) is a type of benzodiazepine medication often used in conjunction with complementary drugs to address debilitating seizures associated with Lennox-Gastaut Syndrome, a rare but severe kind of epilepsy that causes atypical, absence, myoclonic, tonic and atonic seizures.

The medication which has been available abroad for years is sold in the United States by Lundbeck Inc. According to the notice, the FDA has approved revisions in both the Onfi drug label and patient medication guide to more accurately describe these Onfi SJS dangers and risks.

Onfi Can Cause Severe Skin Reactions, Death

While the FDA cautions that Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) can occur at any point when taking Onfi, the odds of such serious skin reactions is greater during the first two months of treatment, or when the anti-seizure drug is stopped and then re-started.

Data from the FDA Adverse Event Reporting System (FAERS) database was used to identify 20 cases of either SJS or TEN in patients taking Onfi. Six of the cases occurred in the United States, and 14 occurred abroad. Five of the U.S. reactions occurred in children.

The FDA reported that all the cases investigated resulted in hospitalization of the patients. One of the cases resulted in blindness, and at least one case resulted in death.

“Patients taking Onfi should seek immediate medical treatment if they develop a rash, blistering or peeling of the skin, sores in the mouth, or hives,” reports the FDA. “Health care professionals should discontinue use of Onfi and consider an alternate therapy at the first sign of rash, unless it is clearly not drug-related.”

Onfi SJS Symptoms

The FDA recommends that patients who are currently taking Onfi be monitored for early symptoms of Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), particularly during the initial 8 weeks of treatment or when re-starting the medication.

SJS is a severe, potentially fatal, skin disease in which cell death causes the epidermis to separate from the dermis. TEN, another form of SJS, is a condition that occurs when the top layer of skin detaches from the lower layers of skin all over the body.

Although a large number of cases of these diseases have no known cause, many have been attributed to dangerous drug interactions. SJS symptoms include:

• face or stomach rash
• blisters around the eyes, mouth or vaginal areas
• layers of peeling skin
• burned skin
• severe infection

If you or a loved has taken the anti-seizure drug Onfi and suffered adverse skin reactions such as Stevens Johnson Syndrome, you may be able recover damages in a court of law by pursuing an Onfi SJS lawsuit.