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FDA Warns of Rare But Serious Drug Reaction to Levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and Clobazam (Onfi, Sympazan) Antiseizure Medicines

The Food and Drug Administration (FDA) has recently issued a warning regarding a rare but serious drug reaction associated with two commonly prescribed antiseizure medications: Levetiracetam and Clobazam. These medications are widely used to treat various types of seizures in patients with epilepsy and other seizure disorders. While the reaction is rare, it is important for healthcare professionals and patients to be aware of the potential risks.

Levetiracetam, sold under brand names such as Keppra, Keppra XR, Elepsia XR, and Spritam, is an antiepileptic drug that works by reducing abnormal electrical activity in the brain. It is commonly prescribed for both adults and children with epilepsy. Clobazam, marketed as Onfi and Sympazan, is also an antiseizure medication used to treat certain types of seizures associated with Lennox-Gastaut syndrome, a severe form of childhood epilepsy.

The FDA has received reports of a rare but serious reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome in patients taking these medications. DRESS syndrome is a potentially life-threatening condition that can cause severe skin rash, fever, swollen lymph nodes, and internal organ involvement. If left untreated, it can lead to organ failure and even death.

The FDA has advised healthcare professionals to immediately discontinue Levetiracetam or Clobazam if DRESS syndrome is suspected and to consider alternative treatment options for their patients. Patients who experience symptoms such as rash, fever, swollen lymph nodes, or other signs of DRESS syndrome should seek medical attention promptly.

It is important for healthcare professionals to carefully evaluate the risks and benefits of these medications before prescribing them to patients. They should consider the patient’s medical history, including any previous allergic reactions or hypersensitivity to antiseizure medications. Additionally, patients should be educated about the signs and symptoms of DRESS syndrome and instructed to report any unusual reactions to their healthcare provider.

While the occurrence of DRESS syndrome is rare, it is crucial for healthcare professionals and patients to be vigilant. Early recognition and prompt discontinuation of the medication can significantly improve the patient’s outcome. Alternative treatment options may need to be explored in cases where the risk of DRESS syndrome outweighs the benefits of Levetiracetam or Clobazam.

The FDA continues to monitor reports of adverse events associated with these medications and encourages healthcare professionals and patients to report any suspected cases of DRESS syndrome or other adverse reactions through the FDA’s MedWatch program. This allows for ongoing evaluation of the safety profile of these antiseizure medications and helps ensure that patients receive the most appropriate and safe treatment.

In conclusion, while Levetiracetam and Clobazam are effective antiseizure medications, healthcare professionals and patients should be aware of the rare but serious risk of DRESS syndrome associated with their use. Prompt recognition and discontinuation of the medication are crucial in managing this potentially life-threatening reaction. Patients should be educated about the signs and symptoms of DRESS syndrome and advised to seek medical attention if they experience any unusual reactions. By staying informed and vigilant, healthcare professionals and patients can work together to ensure the safe and effective use of these medications in the management of seizures.

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