Keppra (Levetiracetam) & Anaphylaxis and Angioedema

Details

Basic Details

Status

Complete

Last Updated

Thursday, November 30, 2017

Health Outcome(s)

anaphylaxis

angioedema

Purpose

Mini-Sentinel

Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR

No

Regulatory Determination / Use

Drug Safety Label Change, Warnings and Precautions

Result(s) (1)

Anti-epileptic Drugs and Angioedema

Regulatory Link(s) (1)

FDA Drug Safety Labeling Changes Page