The FDA is warning that treatment with the anti-epileptic clobazam (Onfi) can cause potentially serious side effects, including fatal cases of SJS (SJS) and toxic epidermal necrolysis (TEN), especially during the first 8 weeks of treatment.
Prescribing doctors and patients are urged to consider alternative medications if possible to avoid the risks of severe drug reactions and patient injury. The Lyon Firm is dedicated to reviewing each injury case and to assist in the complex legal process of filing a lawsuit against large drug companies.
Joe Lyon is an experienced product liability lawyer and drug defect attorney representing plaintiffs nationwide in Onfi injury lawsuits.
Onfi Side Effects
The nation’s drug safety agency has approved changes to the Onfi label and medication guide to describe serious health risks to patients. Stevens Johnson syndrome is rare but the serious skin reactions can result in permanent harm and even death. The FDA approved changes to the Onfi drug label and the patient Medication Guide describe the risk of these serious skin reactions and Stevens Johnson Syndrome.
Stevens Johnson Syndrome has been linked to other drugs as well, including over the counter pain pills like ibuprofen, Motrin and Tylenol. More recent research and medical trials have tried to pinpoint certain triggers for SJS, and have gotten closer but can only say that medications may raise the risk of such rare conditions.
Onfi Adverse Reaction
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during drug treatment. However, the likelihood of skin reactions is greater during the first 8 weeks of treatment or when Onfi is stopped and then re-started. All cases of SJS and TEN in the FDA case series have resulted in hospitalization, one case resulted in blindness, and one case resulted in death. See the FDA Drug Safety Communication for a Data Summary and additional information.
Stevens Johnson Syndrome Symptoms
Patients taking Onfi should monitor their health and seek immediate medical treatment if they develop:
- Rash
- Blistering of the skin
- Peeling of the skin
- Sores in the mouth
- Hives.
Onfi Injury Lawsuits
Due to serious side effects being reported, and consumer safety alerts, medical professionals should discontinue the use of Onfi and consider an alternate therapy at the first sign of rash, unless it is clearly not drug-related.
