Details
The U.S. Food and Drug Administration (FDA) identified a potential safety signal for anaphylaxis and angioedema with the use of Keppra (levetiracetam) during routine post-market safety surveillance of the FDA Adverse Event Reporting System (FAERS). To evaluate this signal, the FDA conducted an integrated safety review that included an analysis in the Sentinel System, along with a review of FAERS cases, other data sources, and medical literature.
The Sentinel analysis compared the incidence of angioedema among new users of levetiracetam to that of new users of other antiepileptic drugs. The analysis found that the incidence rate of angioedema in new users of levetiracetam was similar to the rates for other antiepileptic drugs that were already labeled for this risk. Based on the totality of evidence from the case series and the Sentinel analysis, the FDA approved a safety-related labeling change for Keppra (levetiracetam) on April 24, 2017, to add the risk of anaphylaxis and angioedema to several sections of the label, including the Warnings and Precautions section.