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FDA notes increased risk of intussusception with Rotarix

 
• By Nancy Faigen

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.

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.

An interim analysis of the Mexican study on Rotarix suggests that there is an increased risk for intussusception in the...

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