FDA Sees Possible Risk of Fatal Bowel Problem With GSK Vaccine
October 16, 2010
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 that could be fatal.
A statement posted to the FDA's website said the study showed an increased risk of intussusception in the 31-day period following the first dose of Rotarix. Intussusception is a twisting or obstruction of the intestine that can be fatal.
The safety of Rotarix and RotaTeq, a similar vaccine made by Merck, 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.