FDA warns on possible safety issue with GSK's Rotarix

The FDA has raised a red safety flag on GlaxoSmithKline's rotavirus vaccine Rotarix. The agency is reporting that preliminary data from a new study indicates that the vaccine could raise the risk of intussusception, a potentially lethal bowel problem that can block or twist the intestines in infants.

Approved two years ago, regulators have been keeping a close eye on Rotarix, which is given to infants at the ages of two and four months to guard them against gastrointestinal illness. An increased rate of intussusception forced Wyeth to pull a separate vaccine from the market in the late 90s.

The new study, which was mounted in Mexico, was designed to shed a clearer light on the risk of intussusception. And GSK itself is conducting a post-marketing safety study in the U.S. to check on the same safety issue. GSK responded to the FDA's report by stating that it "remains confident in the safety profile of Rotarix and is committed to the highest standards of patient safety."

- here's the report from Dow Jones