FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
Drug Safety Communication (PDF - 241 KB)
What safety concern is FDA announcing?
The U.S. Food and Drug Administration (FDA) is warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). It may start as a rash but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, we are requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines.
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 is FDA doing?
We are requiring manufacturers of these medicines to add new warnings about DRESS to the prescribing information and the Medication Guide for patients and caregivers. For levetiracetam (Keppra, Keppra XR, Elepsia XR, andSpritam), this involves adding a new warning in the Warnings and Precautions section of the prescribing information, which describes the most serious and significant potential safety issues1. Currently the symptoms associated with this condition are described less prominently. For clobazam (Onfi and Sympazan), we are requiring a new warning specifically about DRESS to be added to the prescribing information. Symptoms related to this risk are already described more generally in other sections of the clobazam prescribing information.
[Further information here: https://www.fda.gov/media/174157/download?attachment ]
Prof Joseph Ana
Lead Senior Fellow/ medicalconsultant.
Center for Clinical Governance Research &
Patient Safety (ACCGR&PS) @ HRI GLOBAL
P: +234 (0) 8063600642
E: info@hri-global.org
8 Amaku Street, State Housing, Calabar,Nigeria.
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