Preliminary study shows Rotarix may increase risk of bowel problems

Officials with the Food and Drug Administration said preliminary study results from a study involving Rotarix showed a possible increased risk of serious bowel problems.

Rotarix, manufactured by GlaxoSmithKline, was approved for us in the U.S. in 2008 and is typically given to infants to protect them from a gastrointestinal illness caused by rotavirus, the Wall Street Journal reports.

FDA officials said the study showed an increased risk of intussusception - a twisting or obstruction of the intestine is sometimes fatal - in the 31 day period following the first dose. Rotarix vaccine suggest an increased risk of a serious bowel problem. The vaccine is typically given to babies at two and four months of age.

Officials told the Wall Street Journal that they are now studying the preliminary results and will also review the final data next year when it becomes available.

The safety of Rotarix and RotaTeq, which is manufactured by Merck & co., have carefully been tracked by regulators since another vaccine by then drug-maker Wyeth was pulled off the market in 1999. It was pulled because it was linked to an increased rate of intussusception.

Officials with GlaxoSmithKline said they were currently conducting a study in the United States to assess the potential risk of intussusception after vaccination.

Glaxo officials said they remain confident in the safety profile of Rotarix and that they are committed to the highest standards of patient safety.