The FDA has issued a warning concerning a rare and potentially fatal side effect associated with widely prescribed epilepsy medications. The alert follows the identification of over 40 cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome linked to the seizure medications levetiracetam (known by brand names Keppra or Keppra XR) and clobazam (branded as Onfi or Sympazan).
DRESS syndrome is an uncommon but severe allergic reaction that can become life-threatening if not promptly diagnosed and treated. Individuals taking levetiracetam or clobazam are advised to seek immediate medical attention if they experience unusual symptoms, such as an unexplained rash, fever, or swollen lymph nodes while on these medications, according to the FDA’s announcement on November 28.
While emphasizing the rarity of DRESS syndrome, the FDA urges patients not to discontinue levetiracetam or clobazam without consulting their healthcare provider, as abruptly stopping these medications could result in uncontrolled seizures.
Levetiracetam and clobazam are widely prescribed for epilepsy in the U.S., with millions of prescriptions dispensed annually. The FDA has documented 32 cases of DRESS syndrome in individuals taking levetiracetam and 10 cases in those on clobazam. Among the 42 affected patients, most required hospitalization and medical treatment, and tragically, two patients died.
DRESS syndrome can manifest two to eight weeks after exposure to a triggering drug, presenting symptoms such as fever, skin rash, swollen lymph nodes, and a swollen face. The syndrome can lead to inflammation and damage in organs like the liver, kidneys, and heart, potentially resulting in death.
In response to these findings, the FDA has mandated manufacturers to include warnings about DRESS syndrome in the prescribing information and patient medication guides for levetiracetam and clobazam. This measure aims to increase awareness among patients and healthcare providers about the potential risks associated with these drugs and the early signs of DRESS syndrome.
Furthermore, the FDA encourages individuals to report any side effects experienced while taking these medications through the FDA MedWatch program. It’s essential to note that this information is provided for informational purposes only and is not intended as medical advice.
