Topamax Stevens-Johnson Syndrome Lawsuit | 2025 Latest Updates

Topamax Stevens-Johnson Syndrome Lawsuit Overview

Topamax Stevens-Johnson Syndrome lawsuits focus on severe, life-threatening skin reactions caused by this widely prescribed epilepsy and migraine medication.

These lawsuits allege that Janssen Pharmaceuticals (a Johnson & Johnson subsidiary) failed to adequately warn patients about the serious risks of developing SJS/TEN.

Numerous cases of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis have been documented in medical literature specifically linked to Topamax use.

In 2011, the FDA issued a significant warning about Topamax, noting that women taking the drug during pregnancy were 21 times more likely to have babies with oral cleft birth defects compared to those not taking the medication.

Related Article: Stevens-Johnson Syndrome Lawsuit

What is SJS/TEN?

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis are very serious skin reactions that can range from mild to very severe and can be life-threatening, with SJS and TEN being the most serious.

These forms of adverse drug reactions, or ADRs, are classified as autoimmune diseases and also affect the mucus membranes.

Latest Topamax Lawsuit Updates

• December 2017: A study published in the journal Epilepsia found a strong link between Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis and the use of antiepileptic drugs like Topamax. The researchers used data from the United Kingdom to quantify these risks in new users of 28 different antiepileptic medications [1].

“The results of our study are consistent with those of previous studies of SJS/TEN, which found increased risks of SJS/TEN in new use of carbamazepine, phenytoin, and lamotrigine.” – Noel Frey, Scientist at the Basel Pharmacoepidemiology Unit, University of Basel.

• 2011: The FDA issued a warning stating that women who took Topamax in their first trimester were 21 times more likely to have a baby with an oral cleft birth defect compared to women who did not use the medication. Additionally, those taking Topamax were 3 times more likely to have babies with oral defects than those taking other seizure medications.
• 1996: Topamax was first approved by the U.S. Food and Drug Administration for treating seizures and later approved for migraine prevention. The drug is manufactured and marketed by Johnson & Johnson subsidiary Janssen Pharmaceuticals.

Topamax continues to be widely prescribed for epilepsy and migraine prevention despite these known risks. The exact number of SJS/TEN cases specifically linked to Topamax is not detailed in public records, but medical literature cites numerous documented cases of this severe adverse reaction in patients treated with the drug.

FDA Reports and Statistics

The FDA has issued several safety communications regarding Topamax (topiramate) over the years:

• In March 2011, the FDA warned that pregnant women taking Topamax had a 21-fold increased risk of giving birth to children with oral cleft defects.
• The FDA has categorized Topamax as a Pregnancy Category D medication, indicating there is positive evidence of human fetal risk based on human data.
• The FDA Adverse Event Reporting System (FAERS) has received numerous reports of severe skin reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis associated with Topamax use.
• Adverse event data indicates that SJS/TEN can occur at any time during Topamax treatment, even after years of use, though risk appears highest during the first 8 weeks of treatment.

The rate of SJS/TEN among antiepileptic drug users is estimated to be 1-10 cases per 10,000 new users, significantly higher than the background rate in the general population.

Topamax Injuries & Side Effects

Topamax has been associated with severe adverse reactions, with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis being among the most serious and life-threatening conditions.

• Stevens-Johnson Syndrome (SJS): A severe skin reaction characterized by a painful rash that spreads and blisters, eventually causing the top layer of skin to die and shed. Affects less than 10% of body surface area.
• Toxic Epidermal Necrolysis (TEN): A more severe form of the condition involving detachment of 30% or more of the body’s surface area, often requiring treatment in intensive care or burn units.
• SJS/TEN Overlap: Affects 10-30% of body surface area and represents an intermediate form between SJS and TEN.
• Birth Defects: Including oral cleft defects (cleft lip and/or cleft palate), malformations of the lungs, heart, and limbs, and neural tube defects such as spina bifida.
• Other Side Effects: Can include cognitive impairment, kidney stones, metabolic acidosis, decreased sweating, elevated body temperature, and eye problems.

Early symptoms of SJS/TEN often include flu-like symptoms such as high temperature, sore throat, cough, and joint pain, followed by a rash that usually starts on the upper body before spreading to other areas, including the face, arms, legs, and genitals. This rash then progresses to blistering and skin detachment.

Do You Qualify for a Topamax Lawsuit?

You may qualify for a Topamax lawsuit if:

• You were prescribed and took Topamax for epilepsy, migraines, or another condition.
• You developed Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) after taking Topamax.
• You required medical treatment for your SJS/TEN symptoms, which may have included hospitalization, specialized burn unit care, or ongoing care for complications.
• You can provide medical documentation linking your SJS/TEN diagnosis to Topamax use.

Additionally, mothers who took Topamax during pregnancy and gave birth to children with birth defects such as cleft lip, cleft palate, or other congenital malformations may also qualify for legal action.

Evidence Required for a Topamax Lawsuit

To build a strong case for your Topamax lawsuit, you should gather and preserve the following evidence:

• Medical records documenting your Topamax prescription, including dosage and duration of use.
• Medical diagnosis of Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, or related condition.
• Documentation of all treatments received for SJS/TEN, including hospitalizations, medications, and procedures.
• Photographs of the skin reaction, if available.
• Expert medical opinions linking your condition to Topamax use.
• Documentation of all related expenses, including medical bills, lost wages, and other costs.

An experienced pharmaceutical litigation attorney can help you gather and organize this evidence to strengthen your case.

Damages You Can Recover

Victims of Topamax-induced Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis may be eligible to recover various types of damages, including:

• Medical Expenses: Coverage for hospital stays, specialist care, medications, skin grafts, rehabilitation, and ongoing treatment.
• Lost Wages: Compensation for time missed from work during treatment and recovery.
• Pain and Suffering: Damages for physical pain, emotional distress, and psychological trauma.
• Disfigurement and Scarring: Compensation for permanent scarring or disfigurement resulting from SJS/TEN.
• Permanent Disability: Damages for long-term or permanent disabilities resulting from the condition, such as vision loss or organ damage.
• Punitive Damages: In cases of gross negligence, punitive damages may be awarded to penalize the manufacturer.

Topamax Recall Information

While Topamax (topiramate) has not been recalled from the market due to Stevens-Johnson Syndrome risks, the FDA has required significant safety label updates:

• In 2011, the FDA required updated warnings regarding the increased risk of oral cleft birth defects when Topamax is used during pregnancy.
• The medication now carries a black box warning, the FDA’s strongest warning level, regarding the risk of birth defects.
• Product labeling has been updated to include warnings about the risk of serious skin reactions, including SJS and TEN.

Despite these warning updates, Topamax remains on the market as a treatment for epilepsy and migraine prevention.

Statute of Limitations for Topamax Lawsuits

The statute of limitations for filing a Topamax Stevens-Johnson Syndrome lawsuit varies by state, typically ranging from 1-6 years from the date of injury or discovery of the connection between the injury and the medication.

Most states follow a “discovery rule,” meaning the time limit begins when you knew or reasonably should have known that your injury was caused by Topamax.

For cases involving birth defects, the statute of limitations may be extended, with many states allowing minor children to file claims until they reach the age of majority or shortly thereafter.

Because of these varying timeframes, it’s crucial to consult with an experienced pharmaceutical litigation attorney as soon as possible after experiencing Topamax-related injuries to ensure your claim is filed within the appropriate time limits.

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Time is limited to pursue legal action for injuries caused by Topamax.

Most states have statutes of limitations ranging from 1-6 years for drug injury cases, and waiting too long could permanently bar you from seeking the compensation you deserve.

At Schmidt & Clark, LLP, we offer:

• Free, confidential consultations to evaluate your Topamax case
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• Payment only if we win your case or secure a settlement
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Don’t delay in seeking the justice and compensation you deserve for your Topamax-related injuries. Contact our team today to understand your legal options and begin the process of filing your claim.

References:

1. https://pubmed.ncbi.nlm.nih.gov/29027197/