Update: Information on Rotarix- Labeling Revision Pertaining to Intussusception

Title Update: Information on Rotarix- Labeling Revision Pertaining to Intussusception
Date
Tuesday, September 4, 2012
Link
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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.

Medical Product
Rotarix
Health Outcome
febrile seizure