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Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq)

June 15, 2007

Audience: Pediatric healthcare professionals, consumers

[Posted 06/15/2007] FDA informed healthcare professionals of changes to the ADVERSE REACTIONS and POST-MARKETING sections of the product's prescribing information. The ADVERSE REACTIONS section was updated to include six cases of Kawasaki disease that were observed during the Phase 3 clinical trial. There were five cases among the 36,150 infants who received RotaTeq and one case among the 35,536 infants who received placebo. The POST-MARKETING section of the prescribing information was revised to reflect three reports of Kawasaki disease to the Vaccine Adverse Event Reporting System (VAERS) since licensure on February 3, 2006. There is not a known cause and effect relationship between receiving RotaTeq, or any vaccine and the occurrence of Kawasaki disease.

Kawasaki disease is a serious, but uncommon illness in children that is poorly understood and the cause has not been determined. It is characterized by high fever and inflammation of the blood vessels and affects the lymph nodes, skin, mouth and heart. The cases reported to date are not more frequent than what could be expected to occur by coincidence. FDA and the Centers for Disease Control and Prevention will continue to monitor the safety of RotaTeq and all vaccines and encourage that all severe adverse events, including any additional cases of Kawasaki disease after administration of RotaTeq, as well as other vaccines, be reported to VAERS.

[June 15, 2007 - Information Page - FDA]

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