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The Food and Drug Administration (FDA) has issued a drug safety communication alerting healthcare professionals and patients about a critical warning regarding certain antiseizure medications. The medications in question, levetiracetam (marketed as Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (sold as Onfi, Sympazan), have been identified to carry a rare but severe reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
DRESS is a potentially life-threatening condition that, although rare, requires immediate medical attention once identified. The FDA emphasized that while the initial symptoms may manifest as a rash, the condition can rapidly escalate, causing harm to internal organs, necessitating hospitalization, and, in severe cases, leading to fatalities.
To address this alarming risk associated with these antiseizure medications, the FDA has mandated that explicit warnings about the potential of developing DRESS be included in the prescribing information and patient Medication Guides for these drugs. These enhanced warnings aim to inform healthcare providers and patients about the urgency of recognizing and promptly addressing any signs or symptoms associated with DRESS while using these medications.
Patients currently taking levetiracetam or clobazam are advised not to discontinue their medication without consulting their healthcare provider. Instead, individuals are encouraged to seek immediate medical attention if they experience any unusual or severe skin reactions, such as a rash, along with fever or other systemic symptoms.
The FDA continues to monitor and evaluate the safety profiles of various medications and urges healthcare professionals and patients to report any adverse effects or concerns associated with these or any other drugs to the FDA’s MedWatch program.
This recent development underscores the importance of close monitoring and awareness among healthcare providers and patients regarding potential adverse reactions associated with medications, particularly when addressing critical conditions like seizures.
