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. The update added the following to the "Warnings and Precautions" section of the Keppra label:
KEPPRA can cause anaphylaxis or angioedema after the first dose or at any time during treatment. Signs and symptoms in cases reported in the postmarketing setting have included hypotension, hives, rash, respiratory distress, and swelling of the face, lip, mouth, eye, tongue, throat, and feet. In some reported cases, reactions were life- threatening and required emergency treatment. If a patient develops signs or symptoms of anaphylaxis or angioedema, KEPPRA should be discontinued and the patient should seek immediate medical attention. KEPPRA should be discontinued permanently if a clear alternative etiology for the reaction cannot be established.