Information on Rotarix Labeling Revision Pertaining to Intussusception

Basic Details
Date
Tuesday, September 4, 2012
Communication Type
Labeling Change
Safety Communication
FDA Center
CBER
Medical Product
Rotarix
Health Outcome(s)
febrile seizure
Description

FDA update about recently approved revised prescribing information and patient labeling for the Rotarix vaccination given to infants in the United States. FDA is currently conducting a study in Mini-Sentinel’s Postlicensure Rapid Immunization Monitoring system (PRISM) to evaluate the risk of intussusception following administration of Rotarix.