clobazam and levetiracetam

Various manufacturers

NEW WARNING

The FDA has issued a drug safety communication to alert patients and health care professionals to the risk of drug reactions with eosinophilia and systemic symptoms (DRESS) associated with the use of antiseizure medications clobazam (Onafi, Sympazan) and levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam). The occurrence of DRESS is rare but serious and can become life-threatening if not identified and treated promptly. It can start as a rash and quickly progress, causing liver, kidney, lung, heart, or pancreas injury; hospitalization; and death.

Health care professionals should monitor for DRESS (facial swelling, fever, rash, swollen lymph nodes, painful oral sores or sores around the eyes, sore throat, trouble swallowing or breathing, unusual bruising or bleeding, severe weakness or fatigue, or severe muscle pain). Signs and symptoms often begin 2 to 8 weeks after initiation of the drug. Symptoms and their severity can widely vary. Patients should be instructed to watch for signs and symptoms of DRESS and to stop the drug and seek immediate medical attention for suspected DRESS.

Adverse effects from the use of clobazam or levetiracetam should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: February 2024

Nursing Drug Handbook

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