FDA Issues Warning of Rare but Serious Drug Reaction to the Antiseizure Medicines

The United States Food and Drug Administration (FDA) recently warned consumers that certain antiseizure medications can cause a rare but serious response called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). When not diagnosed and treated rapidly, these can prove fatal. The affected seizure medications are levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan). Patients are advised to seek medical attention if they develop swollen lymph nodes, fever, or unexplained rash. If you develop an adverse drug reaction to anti-seizure medications, you should call the seasoned Chicago-based dangerous drug lawyers of Moll Law Group. Billions have been recovered in product liability cases with which we’ve been involved.

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The antiseizure medications are approved for different uses. Levetiracetam, which has been FDA-approved for 24 hours and can be accessed in several formulations under the brand names Keppra, Keppra XR, Elepsia XR, and Spritam, and as generics. It can be used along to treat seizures or with other medicines and can be accessed in many formulations under brand names.

Clobazam, for instance, is a benzodiazepine that is FDA-approved for use with other medicines to control linked to a type of epilepsy called Lennox-Gastaut Syndrome. Benzodiazepines depress the central nervous system, but DRESS and other skin reactions are associated with Clobazam, which has been approved by the FDA for 12 years, and not the other benzodiazepines. It can be accessed under the brand names Onfi and Sympazan, and as generics.

Manufacturers are supposed to add additional warnings to DRESS to the information about prescribing and the guide for the medication. The warnings can vary depending on the specific medication in questions. The manufacturers of levetiracetam (Keppra, Keppra XR, Elepsia XR, and Spritam), for instance, must add a new warning to describe the most severe and substantial potential safety issues. Meanwhile a new FDA warning about DRESS needs to be added to Onfi and Sympazan’s prescribing information. DRESS is distinct from Stevens-Johnson Syndrome and toxic epidermal necrolysis.

When these medications are stopped suddenly, the result may be uncontrolled seizures so if you take these medications you should talk to your doctor, rather than stopping medications without warning. Your health care provider needs to be aware that prompt recognition and treatment can be critical to improving DRESS outcomes and reducing mortality.

Diagnosis is often difficult because early signs and symptoms such as fever and swollen lymph nodes may be present without evidence of a rash. DRESS can develop 2 weeks to 8 weeks after starting the medicines, and symptoms and intensity can vary widely. DRESS can also be confused with other serious skin reactions such as SJS and TEN. Advise patients of the signs and symptoms of DRESS and to stop taking their medicine and seek immediate medical attention if DRESS is suspected during treatment with levetiracetam or clobazam.

The FDA determined there were 32 serious cases of DRESS in children and adults globally who had taken levetiracetam and 10 for clobazam. Two patients using levetiracetam died.

The FDA found that there was reasonable evidence that these anti-seizure drugs caused DRESS based on when the events started after getting the medicines and order that the events happened.

The FDA has asked patients and health care providers to report side effects involving these medications to the FDA MedWatch program.

However, if you were injured because you were not adequately warned about an antiseizure medication, you may have grounds to bring a product liability lawsuit against the manufacturer for marketing defects. Often these involve failure to warn. Our lawyers may need to establish negligence, strict liability, breach of warranty, or even medical malpractice against a doctor to recover damages on your behalf.

Call Our Experienced Product Liability and Medical Malpractice Attorneys

If you or a loved one was injured due to a defective product like antiseizure medications with inadequate warnings, you should call the trustworthy Chicago product liability lawyers of Moll Law Group. We represent injured people around the country. Please complete our online form or call us at 312.462.1700.