FDA reviewed worldwide cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) associated with levetiracetam and clobazam in children and adults reported to the FDA Adverse Event Reporting System (FAERS) database and found in the medical literature.
Levetiracetam
A search of FAERS and the medical literature through March 2023 identified 32 serious cases of DRESS worldwide. Three cases occurred in the U.S. and 29 abroad. In all 32 cases, the patients were hospitalized and received medical treatment; in two cases the patients died. The median time to onset was 24 days (range 7 to 170 days). The reported signs and symptoms included skin rash (n=22), fever (n=20), eosinophilia (n=17), lymph node swelling (n=9), and atypical lymphocytes (n=4). Twenty-two cases reported injury to one or more organs, including the liver (n=20), lungs (n=4), kidneys (n=3), and gallbladder (n=1). Twenty-five of the 29 cases for which information on treatment discontinuation was available reported that DRESS symptoms resolved when levetiracetam was discontinued.
Clobazam
A search of FAERS and the medical literature through July 2023 identified 10 serious cases of DRESS worldwide, one in the U.S. and nine abroad. In all 10, the patients were hospitalized and received medical treatment. No deaths were reported. The median time to onset was 21.5 days (range 7 to 103 days). The reported signs and symptoms included skin rash (n=10), fever (n=8), eosinophilia (n=7), facial swelling (n=7), leukocytosis (n=4), lymph node swelling (n=4), and leukopenia/thrombocytopenia (n=1). Nine cases reported injury to one or more organs, including the liver (n=7), kidneys (n=3), and gastrointestinal tract (n=1). DRESS symptoms resolved in all 10 when clobazam was discontinued. DRESS and other serious skin reactions reported with clobazam have not generally been associated with other benzodiazepines.
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- Source: https://www.drugs.com/fda/fda-warns-rare-but-serious-reaction-antiseizure-medicines-levetiracetam-keppra-keppra-xr-elepsia-xr-14638.html