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news.The FDA has released a statement warning that Merck & Co.'s rotavirus vaccine for infants with diarrhea can induce a serious bowel condition where the intestines become twisted.
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The agency commented that there were about 28 cases of infants suffering from these side effects but that it was not immediately apparent if the vaccine was the cause of the condition, known as intussusception. A delay in treatment for this illness can result in serious complications, including tissue damage, perforation of the bowel and death.
Intussusception, however, is a condition that can occur in infants generally and the FDA also cautioned that the numbers do not exceed the normal rate expected to occur on an annual basis.
The vaccine, RotaTeq, has been distributed in the United States since its approval last February, the FDA said.
In its notification, the FDA said it wanted to encourage reports of any bowel conditions in infants administered with the vaccine, in order to asses the seriousness of any potential risk. There would also be an amendment to the label to warn about the risks with the vaccine.
Before RotaTeq was approved, research in 70,000 infants showed that the vaccine did not increase the risk of intussusception.