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.
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.
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.
Patients taking Onfi should monitor their health and seek immediate medical treatment if they develop:
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.
By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.