FDA notes increased risk of intussusception with Rotarix
This article was originally published in Scrip
Executive Summary
The US FDA said that preliminary results from a post-marketing study in Mexico involving GlaxoSmithKline's rotavirus vaccine, Rotarix, suggests a small increased risk of the bowel abnormality intussusception in the 31 day period after the first dose, and that these interim results can now be found in the US label for the product under "Warnings and Precautions". Information has also been added to the postmarketing experience section.