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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)

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Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Wed, 4/10/24: 12:00 AM EDT
Ends On: Fri, 4/9/27: 12:00 AM EDT
Type: Enduring Material
Credits: 0.5
Description: This enduring material focuses on the recent drug safety communication warning of the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) with levetiracetam and clobazam. The presenter will describe the signs and symptoms of DRESS, as well as changes in the prescription labeling for both medications.
Objectives:
  • Describe the steps healthcare professionals and patients should take if DRESS is suspected.
  • Recognize the signs and symptoms associated with DRESS.
  • Identify the changes FDA is requiring manufacturers of levetiracetam and clobazam to make in the prescribing information and medication guides.
  • Summarize the results of the review done by FDA to assess the risk of DRESS in adults and children.
Additional Information: Review the Activity Announcement for additional details: Announcement Form