New warnings issued by the U.S. Food and Drug Administration (FDA) that the anti-seizure drug Onfi (clobazam) can cause life-threatening skin reactions called Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have prompted the medical community to closely monitor Onfi patients for signs of SJS and TEN, especially during the first eight weeks of treatment or when restarting the drug.

All  reported cases of SJS and TEN from Onfi exposure have resulted in hospitalization, one in blindness, and one in death.

Stevens Johnson Syndrome and Toxic Epidermal Necrolysis

Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are rare but severe, life-threatening skin reactions that cause the top layer of  the skin to detach and fall off in large sheets.

In extreme cases, Stevens Johnson Syndrome can destroy eye tissue, causing blindness or can spread to internal organs such as the lungs, heart, kidney, and liver. In this stage, large areas of the skin can become detached and lesions may develop in the mucous membranes.

Onfi Skin Reactions

Onfi skin reactions are extremely dangerous, painful, and disfiguring and can lead not only to life-threatening infections, but also to organ damage, blindness, and death.

Common Onfi skin reaction symptoms include, but are not limited to:

• Pain of the skin
• Red or purple rashes that spread from the face
• Swelling of the face or tongue
• Hives
• Skin detaching or sloughing off in sheets
• Blisters on the mouth, nose, or eyes
• Hives
• Tiredness
• Fever, chills, headaches, muscle aches, joint pains
• Sore throat

FDA Warning About Onfi and Stevens Johnson Syndrome

The FDA approved Onfi for public use in 2011 to treat seizures for individuals with Lennox-Gastaut Syndrome, a rare form of epilepsy. However, some individuals taking Onfi have experienced allergic reactions that trigger Stevens Johnson Syndrome.

On Dec. 3, 2013, the FDA warned that the anti-seizure drug Onfi can cause rare but serious skin reactions that can result in permanent harm and death.

The Drug Safety Communication came after a review of adverse events linked to Onfi to 20 skin reaction cases involving Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The FDA is advising clinicians to closely monitor patients taking Onfi for SJS and TEN, especially at the start of therapy or when the drug is reintroduced.

Onfi SJS Lawsuits

Pharmaceutical companies are obligated to follow strict laws and protocols when it comes to prescription drugs or products they manufacture for consumer use. Companies who fail to abide by these laws could be civilly liable to those harmed by their product or drug.

It has been alleged that Onfi manufacturer, Lundbeck, may have failed to adequately research the potential side effects of Onfi or warn about the risk of users developing severe skin reactions.

The FDA is now requiring new label warnings for the medication warning patients of potential skin reactions. Individuals previously diagnosed with Stevens Johnson Syndrome or Toxic Epidermal Necrolysis may be entitled to financial compensation through an Onfi lawsuit.