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Information on Rotarix Labeling Revision Pertaining to Intussusception

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

    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.