On November 28, 2023, the U.S. Food and Drug Administration (FDA) issued a warning that levetiracetam (Keppra®, Keppra XR®, Elepsia™ XR, Spritam®) and clobazam (Onfi®, Sympazan®)®) can cause Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a rare but serious and potentially life-threatening adverse reaction if not detected and treated quickly. 

Symptoms of DRESS may start as a rash, but also appear as fever or swollen lymph nodes even if a rash is not present, and can quickly progress, resulting in injury to internal organs (such as liver, kidneys, lungs, heart, and pancreas), the need for hospitalization, and even death.

Levetiracetam is an anticonvulsant approved for use alone or with other medications to control certain types of seizures. According to the FDA, use of levetiracetam has been associated with 32 cases of DRESS in children and adults worldwide through March 2023.  

Clobazam is a benzodiazepine approved for use in combination with other medications to control seizures associated with Lennox-Gastaut syndrome, a severe form of epilepsy. The FDA has reported ten cases of DRESS in children and adults worldwide through July 2023.  

As a result, the FDA now requires warnings about this risk in the prescribing information and patient Medication Guides for these medications.

Impact on workers’ compensation and auto no-fault

Levetiracetam and clobazam may be used to control seizures secondary to a catastrophic injury or head trauma associated with a workers’ compensation injury or auto accident. Levetiracetam may also be prescribed off-label to treat neuropathic pain due to other causes. 

Injured persons and their caregivers are advised to talk to their prescriber or healthcare professional regarding the advice of the FDA and should be reminded of the following:

• Do not stop taking the medication abruptly as it may lead to uncontrolled seizures
• Look for the signs and symptoms of DRESS, such as rash, fever, or swollen lymph nodes
• Understand that symptoms may develop two to eight weeks after starting the medication, but can also happen earlier or later
• Go to the emergency room immediately if any unusual symptoms or reactions (including a rash) develops at any time while taking these medications. 

If you have any questions, please contact your account manager, clinical liaison, or our Clinical Services team at 1-877-275-7674 ext. 8612.

Source:

1. U.S. Food and Drug Administration (FDA). FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan). November 28, 2023. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-rare-serious-drug-reaction-antiseizure-medicines-levetiracetam-keppra-keppra-xr-elepsia-xr.