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FDA warns of serious potential reaction to levetiracetam and clobazam

News
Article

The reaction, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), can start as a rash but can progress quickly, potentially resulting in injury to internal organs, hospitalization, and death. 

FDA warns of serious potential reaction to levetiracetam and clobazam | Image Credit: © monticellllo - © monticellllo - stock.adobe.com.

FDA warns of serious potential reaction to levetiracetam and clobazam | Image Credit: © monticellllo - © monticellllo - stock.adobe.com.

Takeaways

  • FDA warns of rare and potentially life-threatening reaction (DRESS) with antiseizure medicines levetiracetam and clobazam.
  • DRESS can quickly progress from rash to organ injury, hospitalization, and death.
  • Additional warnings mandated on prescribing information and patient guides for levetiracetam and clobazam.
  • Levetiracetam (24 years approved) and clobazam (12 years approved) can cause DRESS, with specific side effects noted for each.
  • Health professionals urged to recognize DRESS symptoms, stop medication if suspected, and report adverse events to FDA's MedWatch.

The FDA is warning health professionals, patients, and pharmacies that antiseizure medications levetiracetam (Keppra, UCB; Keppra XR, UCB; Elepsia XR, Tripoint; Spritam, Aprecia) and clobazam (Onfi, Lundbeck; Sympazan, Aquestive) can cause a rare but serious and potentially life-threatening reaction.

The reaction, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), can start as a rash but can progress quickly, potentially resulting in injury to internal organs, hospitalization, and death.

Because of the serious potential reaction, the FDA is requiring warnings be added to prescribing information and patient medical guides for levetiracetam and clobazam.

DRESS can include rash, fever, injury to organs (liver, kidneys, heart, lungs, or pancreas), and swollen lymph nodes.

Levetiracetam is approved as an antiseizure medicine as a monotherapy or in conjunction with other medicines to control seizures in adults and children.

Approved by the FDA for 24 years, common side effects of levetiracetam include aggression or unusual irritability, loss of balance or coordination, confusion, and extreme drowsiness.

Clobazam is a benzodiazepine indicated for use in combination with other medicines to control seizures in adults and children (aged 2 years and up) who have a specific severe version of epilepsy called Lennox-Gastaut syndrome.

DRESS and other serious skin reactions that have been reported with clobazam have “generally been associated only with clobazam and not with other benzodiazepines,” according to the FDA.

Approved by the FDA for 12 years, common side effects of clobazam include tiredness, difficulty speaking or swallowing, change in appetite, and problems with muscle control or coordination.

The FDA advises health care professionals to be aware that quick recognition and early treatment is important for improving DRESS outcomes and decreasing mortality.

DRESS can develop 2 to 8 weeks after starting medicine and symptoms can vary widely, along with intensity. DRESS could be confused with other skin reactions such as Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS).

Providers should advise parents of the signs and symptoms of DRESS and to stop medication if it is suspected during levetiracetam or clobazam treatment.

The federal agency is encouraging health care professionals to report adverse events or side effects associated with levetiracetam or clobazam to the FDA’s MedWatch Safety Information and Adverse Event Reporting program.

Reference:

Antiseizure medicines Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam): Drug safety communication - FDA warns of rare but serious drug reaction. FDA. Press release. November 28, 2023. Accessed November 29, 2023. https://www.fda.gov/safety/medical-product-safety-information/antiseizure-medicines-keppra-keppra-xr-elepsia-xr-spritam-levetiracetam-and-onfi-sympazan-clobazam

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