Onfi, generic clobazam, is a benzodiazepine medication often used in conjunction with other medications to treat seizures resulting from a severe form of epilepsy called Lennox-Gastaut Syndrome (LGS).

Manufactured by the Danish pharmaceutical company Lundbeck, Onfi was approved by the U.S. Food and Drug Administration (FDA) in October 2011. By September 2013, more than 30,000 Americans had been prescribed Onfi. However, since the drug was approved for consumer use, it has been linked to Stevens Johnson Syndrome.

FDA Warning About Onfi and 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 reactions involving Stevens Johnsons 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.

Steven-Johnsons Syndrome and Toxic Epidermal Necrolysis

Stevens Johnsons Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are rare but severe life-threatening skin reactions that cause the top layer of skin to detach and fall off in large sheets. With SJS the skin may appear burned, while blisters may also develop on mucous membranes located at the eyes, mouth, and genitals and ultimately spread from all over the body to inside the intestines, lungs, and stomach.

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

• Skin pain
• Swelling of the face or tongue
• Hives
• Skin detaching or sloughing off in sheets
• Blisters on the mouth, nose, or eyes
• Tiredness
• Fever, chills, headaches, muscle aches, joint pains
• Sore throat

The FDA has ordered the manufacturer of Onfi to add warnings about these skin reactions to its label. Since the FDA announcement, Onfi drug packaging and informational pamphlets have been revised to include information about the risk for serious skin reactions.

Onfi Stevens Johnson Syndrome 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 that fail to abide by these laws could be civilly liable to those harmed by their product or drug. According to some Onfi lawsuits, Lundback may have failed to adequately research the potential Onfi side effects or warn about the risk of users developing severe skin reactions.

The FDA is now requiring new label warnings for the medication, but individuals previously diagnosed with Stevens Johnson Syndrome or Toxic Epidermal Necrolysis may be entitled to financial compensation through an Onfi lawsuit.