FDA Issues Alert on Rare Life-Threatening Reaction Linked to Anti-Seizure Medications

29 Nov 2023 • The U.S. FDA has issued a warning, stating that the antiseizure medications levetiracetam and clobazam could cause a rare but serious reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS can develop 2-8 weeks after starting treatment.

The agency is now requiring warnings about DRESS to be added to the levetiracetam and clobazam prescribing information and patient medication guides.

This hypersensitivity reaction to these medicines is serious but rare. DRESS can include fever, rash, swollen lymph nodes, or injury to organs including the liver, kidneys, lungs, heart, or pancreas.

What should health care professionals do?

  • 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 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.

Source: FDA | Read full story

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