The anti-seizure drug Onfi (clobazam), very much like Lamictal, 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 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)
Both of 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. The 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. If you or a loved one has experienced these severe side effects, consulting with a personal injury lawyer could be a crucial step.
Onfi Side Effects
Below are listed many of the possible reactions from taking the drug. The list is extensive but not all inclusive.
- 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)
- Hives
- Skin detaching and sloughing off in sheets
- Burning eyes
- Cough
- Lethargy (tiredness)
- Fever, chills
- Headache, muscle aches, joint pain
- Sore throat.
Onfi Skin Reactions: FDA Safety Warnings
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 six cases in the United States. All patients were hospitalized, one suffered blindness, and two deaths were potentially caused by Onfi. Families affected by these severe reactions might consider consulting with a wrongful death lawyer for guidance.
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.
Where We are Today: Updated Prescribing Information for Onfi
Lundbeck has been required to and now does provide updated prescribing information for Onfi. It now includes the following warnings about life-threatening skin reactions:
Onfi Lawsuit
In February 2014, a 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).
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)
- Hives
- Skin detaching and sloughing off in sheets
- Burning eyes
- Cough
- Lethargy (tiredness)
- Fever, chills
- Headache, muscle aches, joint pain.
Onfi Lawsuits & Injury Claims
If you or a loved one has encountered a victim of a dangerous drug and have experienced any of the side effects listed above, please contact our office for a free and confidential consultation regarding your possible claim. We are here to help you understand the complexities involved in these cases and your possible claims against the manufacturers of these drugs. You make the decisions, but we can help you make informed decisions — and you are not alone.
Attorney David Mann
Before leading his own firm, Mann served for several years as in-house defense counsel for a large insurance company, which gives him unique insight into how insurance companies work. He uses this critical knowledge as an advantage for his clients. He is a tough negotiator and litigator, and he is exceptionally strategic in building cases on behalf of personal injury victims.[ Attorney Bio ]
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