Amanda Antell  |  November 20, 2014

Category: Legal News

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Onfi Stevens Johnson SyndromeOnfi (clobazam) is a popular anti-seizure medication that is prescribed to patients who suffer from a specific form of epilepsy. As of December 2013, Onfi officially joined the FDA’s list of drugs that have been indicated to cause Stevens Johnson Syndrome.

The FDA now requires Onfi’s manufacturer, Lundback, to include language on the drug label that Onfi and its generic form clobazam can cause Stevens Johnson Syndrome, a rare but serious skin reaction that can result in permanent harm and death. The agency warns Onfi users to watch out for signs of Stevens Johnson Syndrome symptoms, which typically start with flu-like symptoms and a skin rash that appear within the first two weeks of starting the medication.

The warning for Onfi Stevens Johnson Syndrome (SJS) also mentions the more severe cousin of SJS, Toxic Epidermal Necrolysis (TEN). The main difference between the two conditions is the amount of skin surface area they consume. Stevens Johnson Syndrome can take up to 30% of the skin, while Toxic Epidermal Necrolysis can take up to 90%. Both conditions can also affect the mucous membranes such as the eyes, mouth and genitals.

Lundback officially made this label change soon after the FDA’s public warning announcement about Onfi Stevens Johnson Syndrome on Dec. 03, 2013. A number of Onfi SJS lawsuits allege this warning should have been issued sooner, and that the drug maker negligently withheld the risk for Stevens Johnson Syndrome from consumers.

Stevens Johnson Syndrome Symptoms

The FDA advises Onfi users to seek immediate medical intervention if they start developing flu symptoms and skin rashes, typical signs of Stevens Johnson Syndrome symptoms which can develop in Toxic Epidermal Necrolysis. SJS and TEN can be fatal if not treated in time, so doctors urge patients to always be on the lookout for adverse side effects.

When Stevens Johnson Syndrome symptoms progress they can cause severe organ damage and permanent skin damage. Due to the nature of SJS skin lesions, patients are often treated in the hosptial’s burn unit. Skin lesions caused by Stevens Johnson Syndrome are infamous for being red or purplish in color, and for causing the skin to peel and detach from the body. Skin grafts are often required to replenish lost skin.

Overview of Onfi SJS Link

Onfi (clobazam) was approved by the FDA in October 2011 to treat patients with a severe form of epilepsy called Lennox-Gastaut Syndrome (LGS). Since its release, approximately 31,000 patients have been prescribed Onfi with at least six cases of SJS reported to the FDA; five of them involved children. Of these children, one became blind and two died from SJS complications.

Healthcare experts estimate that 300 cases of SJS are diagnosed per year in the United States. SJS is more common in adults than children.

Onfi users are advised not to discontinue the medication unless advised by their physician to avoid complications. Onfi withdrawal symptoms include constant seizures, hallucinations, anxiety, and muscle cramps.

Patients who developed Onfi SJS may be eligible to pursue legal recourse for their injuries. Onfi lawsuits allege that the drug label had insufficient warnings for Stevens Johnson Syndrome. The charges in these Onfi lawsuits include: negligence, false advertising, concealing information, and misrepresenting a product.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Stevens Johnson Syndrome attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, SJS lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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Help for Victims of Onfi Stevens Johnson Syndrome

If you or a loved one were diagnosed with Stevens Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) after taking Onfi, you may be eligible to take legal action against the drug’s manufacturer. Filing an Onfi SJS lawsuit or Onfi class action lawsuit may help you obtain compensation for medical bills, pain and suffering, and other damages. Obtain a free and confidential review of your case by filling out the form below.

An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

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Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.