Onfi, a benzodiazepine medication, is often prescribed in combination with other medications in an attempt to prevent epileptic seizures. Manufactured by the Danish pharmaceutical company, Lundbeck, Onfi has been prescribed to treat epilepsy and other mental disorders for over a decade.

However, since Onfi was approved by the U.S. Food and Drug Administration (FDA) in 2011, it has been linked to Stevens Johnson Syndrome, a rare but serious skin reaction that may result in permanent damage or death.

FDA Warning About Onfi and Stevens Johnson Syndrome

The FDA has issued a public warning that Onfi (clobazam) can cause Stevens Johnson Syndrome and toxic epidermal necrolysis (TEN) at any time during treatment involving Onfi. The likelihood of skin reactions including SJS and TEN is greater during the first eight weeks of Onfi treatment.

The likelihood of a reaction is also increased when Onfi is stopped and subsequently restarted. According to FDA case studies, all cases of SJS and TEN associated with the drug Onfi have resulted in hospitalization. In addition, one Onfi case resulted in blindness, and one Onfi case resulted in death.

Stevens 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.

In extreme cases Stevens Johnson Syndrome can destroy eye tissues 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.

Common Onfi side effects 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
• Skins Detaching or Sloughing Off in Sheets
• Blisters on the Mouth, Nose, or Eyes
• Hives
• Tiredness
• Fever, Chills, Headaches, Muscle Aches, Joint Pains
• Sore Throat

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 who fail to abide by these laws could face Onfi SJS lawsuits filed by those harmed by their products or drug. These Onfi lawsuits may allege that Lundback 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, but individuals previously diagnosed with Stevens Johnson Syndrome or toxic epidermal necrolysis may be entitled to financial compensation through an Onfi lawsuit.