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A recently updated United States Food and Drug and Administration (FDA) website reported a change in the labeling and safety warning for the vaccine Rotarix (Rotavirus Vaccine, Live, Oral) Oral Suspension. The FDA website which was updated October 17, under the September 2012 dated headline, reads, "In a post marketing, observational study conducted in Mexico, cases of intussusception were observed in temporal association within 31 days following the first dose of Rotarix, with a clustering of cases in the first 7 days."
Under the page's March 2011 detailed view of Rotarix's safety labeling changes approved by the FDA Center for Biologics Evaluation and Research, it reads "Infants with a history of intussusception should not receive Rotarix. In postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose."
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