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FDA Issues Warning About Merck’s Rotavirus Vaccine

Feb 14, 2007 | The U.S. Food and Drug Administration (FDA) is warning pediatric health-care professionals and consumers about potentially life-threatening side effects associated with Merck’s RotaTeq vaccine. According to the agency, several infants who’ve received the rotavirus vaccine have suffered from twisted or blocked intestines.

The FDA noted “28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (trade name RotaTeq), manufactured by Merck and Co. One portion of the intestine telescopes into a nearby portion, causing the intestinal obstruction. The most common site is where the small intestine joins the large intestine.”

At this point, it is unclear whether or not the vaccine is causing the intestinal problems, but the high incidence of this condition has led the FDA to issue an alert even though the number of cases hasn’t exceeded the “expected” rate.

“Approximately 3.5 million doses of RotaTeq have been distributed in the United States through February 1, 2007,” the FDA said. “Not all of these doses have been administered. Since its licensure on February 3, 2006 until January 31, 2007, 28 cases of intussusception have been reported in the U.S. in infants who received RotaTeq. The reported 28 cases occurred after dose 1, dose 2, and dose 3. Approximately half of the cases occurred 1 to 21 days after vaccination, with a range of 0 to 73 days. Sixteen of the 28 infants with intussusception required hospitalization and surgery on their intestine. The remaining 12 infants had reduction of the intussusception by contrast or air enema. No deaths due to intussusception were reported.”

In 1999, Wyeth was forced to pull its rotavirus vaccine from the market due to similar concerns about intussusception. Although rotavirus may cause fever, diarrhea, and vomiting, it is not usually fatal. However, the Centers for Disease Control and Prevention (CDC) still recommends that infants be vaccinated against it. Merck is currently in the midst of a large study of 44,000 children related to their vaccine, but they won’t have complete findings from the study until the end of next year.

RotaTeq had international sales of approximately $163 million in 2006, but that figure is expected to triple in the next three years.

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