The FDA is warning about a serious and potentially fatal adverse event that has been reported with use of the antiseizure medications levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).  The ADE, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), is extremely rare and the “FDA’s cumulative review found 42 serious cases of DRESS in children and adults worldwide (32 for levetiracetam and 10 for clobazam).” 

The Agency is requiring the firms that market these products to add a new warning in the Warnings and Precautions section of the prescribing information, which describes the most serious and significant potential safety issues.  Certain information concerning DRESS is found in labeling in other sections of the labeling for these drugs, but not as prominently. 

While these medications can also cause other serious skin reactions, the key to treating DRESS is early recognition and treatment because, as the FDA explains, “early symptoms of DRESS such as fever or swollen lymph nodes can be present even when a rash cannot be seen.  This is different from other serious skin-related reactions that can happen with these medicines and where a rash is present early on, including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).”  The complete information on the what the FDA found and its plans to further address label changes, along with other pertinent information, can be found in the Agency’s release (here).