Label updated for rotavirus vaccine

June 25, 2007

Information on Kawasaki disease (KD) has been added to the prescribing information for Merck's RotaTeq vaccine after three postmarketing reports were received of KD following vaccination.

Information on Kawasaki disease (KD) has been added to the prescribing information for Merck's RotaTeq vaccine after three postmarketing reports were received of KD following vaccination. Specifically, the Adverse Reactions section of the label has been updated to include six cases of the disease that were observed during the phase III trial of the vaccine prior to its approval and were included in the original BLA submission (five cases received RotaTeq and one placebo). The Postmarketing section will also be revised to include the three new cases reported since the vaccine's licensure in February 2006. According to the FDA, there is no known cause-and-effect relationship between receiving the vaccine and the development of KD, and the reported occurrences does not exceed the number of cases expected based on the usual incidence of KD in children. The FDA will continue to work with Merck and CDC to further study this issue.

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