The anti-seizure drug Onfi (clobazam) can cause deadly skin reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The FDA has received 20 reports of these skin reactions, which cause the outer layer of skin (epidermis) to die and fall off in large sheets.
What You Can Do & How an Onfi Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting Onfi induced injury cases in all 50 states. If you or somebody you know was injured by Onfi skin reactions, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
What is Onfi?
Onfi (clobazam) is an anti-seizure and anti-anxiety medication in a class of drugs called benzodiazepines. It is prescribed in combination with other drugs to prevent seizures associated with a severe form of epilepsy called Lennox-Gastaut Syndrome. Onfi is manufactured by Lundbeck, a Danish pharmaceutical company, and it was approved by the U.S. Food and Drug Administration (FDA) in October 2011. As of September 2013, about 31,000 Americans have been prescribed Onfi.
Skin Reactions from Onfi
Onfi can cause rare but severe, life-threatening skin reactions:
- Stevens-Johnson Syndrome (SJS)
- Toxic Epidermal Necrolysis (TEN)
These conditions cause the top layer of skin to detach and fall off the body in large sheets. Blisters develop on mucous membranes (eyes, mouth, genitals) and may spread all over the body, inside the stomach, lungs, or intestines. Sloughing skin may appear burned. Skin reactions from Onfi are extremely painful, disfiguring, and can lead to life-threatening infections, organ damage, blindness, and death.
FDA Safety Warning for Onfi Skin Reactions
December 3, 2013 — The FDA has published a Drug Safety Communication after a review of adverse events linked Onfi to 20 skin reactions involving SJS or TEN, including 6 cases in the United States. All patients were hospitalized, one suffered blindness, and two deaths were potentially caused by Onfi.
The FDA recommends that doctors should discontinue Onfi in patients who develop a rash or other symptoms of a skin reaction, and it should not be re-started. However, patients need to talk to a doctor before stopping Onfi due to the risk of discontinuation complications. Other benzodiazepine medications are not generally associated with skin reactions.
Updated Prescribing Information for Onfi
Lundbeck has updated the prescribing information for Onfi to include the following warnings about life-threatening skin reactions:
5.4 Serious Dermatological Reactions: Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with ONFI in both children and adults during the post-marketing period. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment initiation or when re-introducing therapy. ONFI should be discontinued at the first sign of rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.”
In February 2014 lawsuit was filed in Texas on behalf of an 11 year-old boy who suffered severe physical disfigurement and psychological trauma after he was prescribed Onfi and developed Stevens-Johnson Syndrome (SJS), a life-threatening skin reaction. Click here to read more.
Symptoms of Onfi Skin Reaction
- Skin pain
- Red or purple rash that spreads from face to chest to body
- Swelling of face or tongue
- Blisters that start on mucous membranes (mouth, nose, eyes)
- Skin detaching and sloughing off in sheets
- Burning eyes
- Lethargy (tiredness)
- Fever, chills
- Headache, muscle aches, joint pain
- Sore throat
Do I have an Onfi Lawsuit?
The Schmidt Firm, PLLC is currently accepting Onfi injury cases in all 50 states. If you or somebody you know was injured by Onfi skin reactions, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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