FDA warns of bowel obstruction risk linked to GSK's Rotarix

09/22/2010 | Reuters

The FDA warned that Rotarix, a rotavirus vaccine by GlaxoSmithKline, might cause an increased risk of a bowel obstruction. The warning is based on preliminary data from a Mexican study involving infants. "Although the results are preliminary and will require further evaluation, FDA approved revised labeling to inform health care providers of this finding," according to the agency's website.

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