FDA warns of risks with Merck & Co's RotaTeq
The US Food and Drug Administration issued a public health notification on drug major Merck & Co's RotaTeq (live oral pentavalent rotavirus), warning of a possible risk of intestinal twisting in children given the vaccine.
The FDA gave the warning in response to 28 cases of the potentially life-threatening condition, which is called intussusception, but noted that this number does not exceed the background rate, adding that it hopes the announcement will improve reporting of cases so that it can better assess the potential risks posed by the new product.
Merck's oral three-dose vaccine was approved in the USA last year for the prevention of rotaviral gastroenteritis in infants aged between six and 32 weeks (Marketletter February 13, 2006). The condition is one of the leading causes of severe diarrhea in young children.
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