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FDA Public Health Notification: Information on RotaTeq and Intussusception

Internet URL

http://www.fda.gov/cber/safety/phnrota021307.htm  

Sponsoring Agency

Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

Description

The Food and Drug Administration (FDA) is notifying health care providers and consumers about 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (trade name RotaTeq), manufactured by Merck and Co., Inc. Intussusception is a serious and potentially life-threatening condition that occurs when the intestine gets blocked or twisted. FDA is issuing this notification both to encourage the reporting of any additional cases of intussusception that may have occurred or occur in the future after administration of RotaTeq, and to remind people that intussusception is a potential complication of RotaTeq,.

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Review Date

2/26/2007