Onfi (clobazam) is an anti-seizure medication associated with rare but serious skin reactions that can cause permanent disfigurement or death. The FDA issued a warning about this risk after identifying 20 cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidemal Necrolysis (TEN), which cause the outer layer of skin to die and fall off.
Need a Texas Onfi Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by Onfi skin reactions, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
What is Onfi?
Onfi (clobazam) is a benzodiazepine medication that is used with other medications to treat seizures associated with Lennox-Gastaut Syndrome, a severe form of epilepsy. The pharmaceutical company Lundbeck received approval for Onfi in October 2011. By September 2013, Onfi was prescribed to about 31,000 patients in the United States.
Onfi Skin Reactions
The U.S. Food and Drug Administration (FDA) warns that Onfi can cause serious skin reactions. The FDA has identified 20 cases of skin reactions (6 cases in the U.S. and 14 foreign cases). Everyone who developed skin reactions needed to be hospitalized, one person suffered blindness, and two deaths were possibly related to Onfi.
Onfi skin reactions:
- Stevens-Johnson Syndrome (SJS)
- Toxic Epidemal Necrolysis
Onfi should be discontinued at the first sign of a rash, unless the rash is clearly not related to Onfi. Patients should not stop taking Onfi without talking to a doctor due to the risk of discontinuation side effects. If patients develop symptoms of a skin reaction, Onfi should not be re-started and other anti-seizure treatments should be considered. Other anti-seizure drugs in the benzodiazepine class have not generally been associated with skin reactions.
FDA Safety Warning for Onfi
December 3, 2013 — The FDA has issued a Drug Safety Communication and updated the drug label on Onfi to include information about skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis:
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 a Skin Reaction from Onfi
Symptoms of a skin reaction from Onfi can occur at any time during treatment, but they are more likely to appear within the first 8 weeks. SJS and TEN cause the outer layer of skin to die and fall off. Redness and blisters appear on face, then chest, and spread to the rest of the body. Painful blisters and sores develop in mouth, eyes, genitals, stomach, lungs, and bowel. When skin falls off, it appears dark and the skin may appear burned.
Symptoms of Onfi skin reaction include:
- Painful rash
- Redness or purple rash that spreads on body
- Face or tongue swelling
- Blisters (especially in mouth, nose, eyes)
- Skin sloughing off
- Burning eyes
- Fatigue (sleepiness)
- Fever and chills
- Muscle and joint pain
- Sore throat
Need an Onfi Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact our Texas Onfi lawyers for a free lawsuit review.