Onfi Lawsuit | 2025 Latest Updates

If you or a loved one experienced Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other severe skin reactions following the use of Onfi medication, you may be entitled to pursue compensation.

At Schmidt & Clark, we are dedicated to helping individuals who have suffered due to dangerous drug side effects.

Our experienced legal team is here to guide you through the process and fight for the compensation you deserve. Contact Schmidt & Clark today for a free, no-obligation consultation.

Onfi Litigation is presently under scrutiny for patients who used the medication and developed severe skin conditions.

In December 2013, the U.S. Food & Drug Administration [1] issued a warning that the use of Onfi (clobazam) could result in Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), both of which are potentially fatal skin disorders.

Following these incidents, the FDA endorsed modifications to the Onfi warning label and the patient Medication Guide to include information about the heightened risk of extreme skin reactions [2].

Free Onfi Lawsuit Evaluation: If you or a loved one developed Stevens-Johnson syndrome or toxic epidermal necrolysis after taking Onfi, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Onfi and we can help.

Onfi Lawsuit Overview

Onfi lawsuits are product liability and pharmaceutical litigation claims focusing on the anti-seizure medication’s connection to severe and potentially fatal skin reactions.

These lawsuits allege that Lundbeck, the manufacturer of Onfi, failed to adequately warn patients and physicians about the risk of developing Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

The U.S. Food and Drug Administration issued a serious warning in December 2013 after multiple cases of these life-threatening skin reactions were reported, including one fatality and one case resulting in blindness.

Since its approval in 2011, over 150,000 prescriptions for Onfi have been written in the United States, creating significant concerns about the drug’s safety profile.

Latest Onfi Lawsuit Updates

December 2013 – The FDA issued a Drug Safety Communication warning that Onfi (clobazam) can cause serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can result in hospitalization, blindness, and death [3].

2013 – The FDA required changes to Onfi’s warning label and patient Medication Guide to include information about the risk of serious skin reactions, particularly during the first eight weeks of treatment or when therapy is resumed after a break.

2011 – Onfi was approved by the FDA for use in conjunction with other medications to treat seizures associated with Lennox-Gastaut Syndrome, a severe form of epilepsy. Since approval, more than 150,000 prescriptions have been written in the United States.

FDA Reports and Statistics

According to FDA reports, serious skin reactions from Onfi can occur at any time during treatment but are more likely to happen during the first eight weeks of therapy or when treatment is restarted after discontinuation.

The FDA’s Adverse Event Reporting System documented multiple cases of SJS and TEN associated with Onfi, all requiring hospitalization and resulting in severe outcomes, including one death and one case of blindness [4].

SJS and TEN are extremely rare conditions, affecting approximately 1-2 people per million annually in the general population.

However, certain medications, including Onfi, can significantly increase this risk. The mortality rate for TEN ranges from 25% to 30%, making it one of the most dangerous adverse drug reactions a patient can experience.

The FDA’s recommendation for healthcare providers includes discontinuing Onfi at the first sign of rash unless it is clearly not drug-related, and considering alternative therapies for managing seizures in affected patients.

Onfi Injuries & Side Effects

Onfi has been linked to severe, life-threatening skin reactions that can have devastating consequences for patients.

These skin conditions can appear suddenly and progress rapidly, requiring immediate medical intervention.

• Stevens-Johnson Syndrome (SJS): A severe, potentially fatal skin disease in which cell death causes the epidermis to separate from the dermis, resulting in widespread blistering, severe pain, and significant risk of infection
• Toxic Epidermal Necrolysis (TEN): An extreme form of SJS where the top layer of skin detaches from lower layers across most of the body surface, creating a condition similar to severe burns with mortality rates of 25-30%
• Permanent Vision Damage: SJS/TEN can affect the mucous membranes of the eyes, potentially leading to scarring, infection, and blindness as documented in at least one Onfi case
• Secondary Infections: When large areas of skin are damaged, patients become highly susceptible to serious bacterial infections that can lead to sepsis and organ failure

Additional symptoms of these conditions include:

• face or stomach rash
• blisters around the eyes, mouth or vaginal areas
• layers of peeling skin
• burned skin
• severe infection

Do You Qualify for an Onfi Lawsuit?

You may qualify for an Onfi lawsuit if:

• You or a loved one was prescribed and took Onfi (clobazam) for seizures associated with Lennox-Gastaut Syndrome or other conditions
• You developed Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) after starting Onfi treatment
• Your skin reaction occurred either during initial treatment (especially within the first eight weeks) or after restarting Onfi following a break in treatment
• You required medical attention, hospitalization, or emergency care for your skin condition
• You experienced significant complications, such as vision impairment, scarring, or other lasting effects from SJS/TEN
• You were not adequately warned about the risk of severe skin reactions before taking Onfi

Evidence Required for an Onfi Lawsuit

To strengthen your Onfi lawsuit, you should gather:

• Medical records documenting your Onfi prescription and usage
• Documentation of your SJS or TEN diagnosis, including notes from dermatologists or other specialists
• Hospital records if hospitalization was required
• Photographs of the skin reaction if available
• Statements from your healthcare providers connecting your skin condition to Onfi use
• Evidence showing the chronological relationship between starting Onfi and developing symptoms
• Documentation of any lasting effects or permanent damage resulting from SJS/TEN

Damages You Can Recover

Victims of Onfi-related skin reactions may be eligible to recover:

• Medical expenses for hospitalization, specialist care, and ongoing treatment
• Rehabilitation costs, including physical therapy and vision therapy
• Lost wages due to inability to work during recovery or permanently
• Pain and suffering related to the physical and emotional trauma of SJS/TEN
• Permanent disability or disfigurement compensation
• Wrongful death damages for families who lost loved ones
• Punitive damages if it can be proven that the manufacturer knowingly concealed risks

Onfi Recall Information

While Onfi has not been recalled from the market, the FDA took significant regulatory action in December 2013 by requiring changes to the drug’s labeling and patient information.

Following reports of serious skin reactions, including cases of SJS and TEN, the FDA mandated that the manufacturer add warnings about these potential adverse effects to the drug’s label and Medication Guide.

Manufactured and marketed by Lundbeck, Onfi (generic: clobazam) is an FDA-approved benzodiazepine medication designed to be used in conjunction with other drugs to treat seizures associated with a type of epilepsy known as Lennox-Gastaut Syndrome.

Clobazam, the main active ingredient contained in Onfi, was first synthesized more than four decades ago. Based on the results of a pair of clinical trials, including the largest study of patients with Lennox-Gastaut Syndrome, Onfi was cleared for sale on the U.S. market in 2011.

The FDA is advising patients who are taking Onfi to consult their physician immediately if they develop a rash, blistering or peeling of the skin, sores in the mouth, or hives.

Healthcare professionals should discontinue use of Onfi and consider an alternate therapy at the first sign of these symptoms, unless the reaction is clearly not related to the drug. Patients should not stop using Onfi without first consulting their doctor.

Discontinuing use of Onfi suddenly can cause severe withdrawal problems, such as seizures, hallucinations, shaking, nervousness, and stomach or muscle cramps.

Statute of Limitations for Onfi Lawsuits

The statute of limitations for filing an Onfi lawsuit varies by state, typically ranging from 1-6 years from the date of injury or discovery of the connection between Onfi and your skin reaction.

Many states apply a “discovery rule,” which means the time limit begins when you knew or reasonably should have known that your injury was caused by Onfi.

Additionally, some states have specific statutes of limitations for pharmaceutical liability cases that may differ from general personal injury time limits.

For example:

• California: 2 years from injury or discovery
• New York: 3 years from injury or discovery
• Texas: 2 years from injury or discovery
• Florida: 4 years from injury or discovery
• Illinois: 2 years from injury or discovery

It’s crucial to consult with an experienced attorney as soon as possible after experiencing Onfi-related skin reactions to ensure your lawsuit is filed within the applicable statute of limitations for your state.

Related Article: Toxic Baby Formula NEC Lawsuit

See other dangerous drug lawsuits we’re currently taking.

FAQs

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for injuries caused by Onfi-related skin reactions. Depending on your state, you may have as little as 1-2 years from the date of your injury or discovery of Onfi’s connection to your condition to file a claim.

At Schmidt & Clark, we offer:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees for our legal services
• Payment only if we win your case or secure a settlement

Don’t delay in seeking legal assistance, as waiting too long could jeopardize your right to compensation for the severe injuries and damages caused by this dangerous drug.

Free Onfi Lawsuit Evaluation: If you or a loved one developed Stevens-Johnson syndrome or toxic epidermal necrolysis after taking Onfi, you should contact our law firm immediately. You may be entitled to compensation by filing an Onfi suit and we can help.

References

1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-serious-skin-reactions-anti-seizure-drug-onfi-clobazam-and
2. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s002,203993s002lbl.pdf
3. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-serious-skin-reactions-anti-seizure-drug-onfi-clobazam-and
4. https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-fda-warns-serious-skin-reactions-anti-seizure-drug-onfi-clobazam-and-has