Along with a recent warning concerning the vaccine's effects in immunodeficient infants, the Food and Drug Administration said preliminary results from a study in Mexico involving GlaxoSmithKline's Rotarix vaccine suggest an increased risk of a serious bowel problem.
Rotarix, approved for use in the U.S. in 2008, is typically given to babies at two and four months of age and is designed to help protect infants from a gastrointestinal illness caused by rotavirus. Merck & Co. (MRK) makes a similar vaccine, RotaTeq. The FDA, in a statement posted to the FDA's website Wednesday, said the study showed an increased risk of intussusception in the 31-day period following the first dose of Rotarix. Most of the cases occurred within the first seven days. Intussusception is a twisting or obstruction of the intestine that can be fatal. The agency said information about the preliminary results from the Mexico study has been added to the product's label to provide doctors with the information.
The safety of Rotarix and RotaTeq have carefully been tracked by regulators since another vaccine by then drug-maker Wyeth was pulled off the market in 1999 after it was linked to an increased rate of intussusception.
Rotarix, approved for use in the U.S. in 2008, is typically given to babies at two and four months of age and is designed to help protect infants from a gastrointestinal illness caused by rotavirus. Merck & Co. (MRK) makes a similar vaccine, RotaTeq. The FDA, in a statement posted to the FDA's website Wednesday, said the study showed an increased risk of intussusception in the 31-day period following the first dose of Rotarix. Most of the cases occurred within the first seven days. Intussusception is a twisting or obstruction of the intestine that can be fatal. The agency said information about the preliminary results from the Mexico study has been added to the product's label to provide doctors with the information.
The safety of Rotarix and RotaTeq have carefully been tracked by regulators since another vaccine by then drug-maker Wyeth was pulled off the market in 1999 after it was linked to an increased rate of intussusception.
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