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Update: Information on Rotarix - Labeling Revision Pertaining to Intussusception

This web page provides an overview of the rotavirus vaccine Rotarix® and concerns regarding the potential side effect of intussusception. It includes a review of data regarding intussusception cases after vaccination, and shares updates on changes that have been made to the prescribing information and patient labeling for Rotarix®. Finally, it addresses what this means for infants in the United States who receive the vaccine and other studies being conducted regarding Rotarix® and intussusception.

Author: US Food and Drug Administration

Published: 2012

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Resource types: Website

Diseases/vaccines: Rotavirus

Topics: Vaccine safety and performance, Disease/vaccine specific information

Regions: North America and Europe