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FDA: Vaccine may be linked to intestinal trouble
By ASSOCIATED PRESS
Published February 14, 2007
WASHINGTON - The government warned Tuesday of potentially life-threatening twisting of the intestines in infants vaccinated against a virus that is the leading cause of early childhood diarrhea. The condition, called intussusception, is the same that led to the withdrawal of the first rotavirus vaccine eight years ago. The Food and Drug Administration said it was unknown whether the recently approved vaccine, called RotaTeq, caused the 28 new cases The condition also can occur spontaneously. Indeed, the reports don't exceed the numbers expected to occur naturally each year, the so-called background rate, the FDA said. In Tuesday's public health notification, the agency said the vaccine's label would mention the cases of intussusception. "It's a known, serious, life-threatening adverse event that is being seen at an expected level postmarketing. But because it is so serious, we asked the company to change the label," FDA spokeswoman Karen Riley said. Dr. Paul Offit, the vaccine's co-inventor, said the 28 reports were well below the hundreds of cases one would expect naturally. The 28 cases included 16 infants who required intestinal surgery. There have been no reports of deaths.
[Last modified February 14, 2007, 00:59:43]
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