Does the FDA Warn About Keppra?

Yes, the U.S. Food and Drug Administration (FDA) has issued warnings regarding Keppra (levetiracetam) and other antiseizure medications.

Details of the FDA Warning

On November 28, 2023, the FDA warned that the antiseizure medicines levetiracetam (brand names Keppra, Keppra XR, Elepsia XR, and Spritam) and clobazam (brand names Onfi and Sympazan) can cause a rare but serious drug reaction. This reaction can be life-threatening if not diagnosed and treated quickly.

The specific drugs mentioned in the FDA's warning include:

• Levetiracetam:
  • Keppra
  • Keppra XR
  • Elepsia XR
  • Spritam
• Clobazam:
  • Onfi
  • Sympazan

Understanding the Serious Reaction

The FDA's warning highlights a rare but potentially severe adverse drug reaction. While not explicitly named in the warning provided, this type of reaction typically refers to Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), which is characterized by a rash, fever, and organ dysfunction.

It is crucial for both patients and healthcare providers to be aware of the signs and symptoms of such a reaction, as timely diagnosis and intervention are vital to prevent serious complications or fatalities.

What Patients and Caregivers Should Do

If you or someone you care for is taking Keppra or any of the other mentioned antiseizure medications, it's important to be vigilant for any unusual symptoms.

• Recognize Potential Symptoms: Be aware of new or worsening symptoms that could indicate a severe drug reaction.
• Seek Immediate Medical Attention: If you suspect you are experiencing a serious reaction, contact your healthcare provider or seek emergency medical care immediately.
• Do Not Stop Medication Abruptly: Never stop taking Keppra or any other prescribed antiseizure medication without first consulting your doctor. Abruptly discontinuing these medicines can lead to serious health consequences, including increased seizure activity.
• Discuss Concerns: Talk to your doctor about any concerns you have regarding your medication and potential side effects. They can provide personalized advice and monitor your health appropriately.

For more detailed information, you can refer to the FDA's official announcement regarding this drug safety warning: FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, and Spritam) and clobazam (Onfi and Sympazan).

Overview of Affected Medications

To clarify the medications specifically mentioned in the FDA warning: