FDA says don’t use Glaxo diarrhea vaccine, citing no safety risk but puzzling contamination

FDA suspends Glaxo rotavirus vaccine as precaution

WASHINGTON — U.S. health officials are telling pediatricians to temporarily stop using one of two vaccines against a leading cause of diarrhea in babies — GlaxoSmithKline’s Rotarix.

The Food and Drug Administration calls Monday’s move a precaution after the discovery that Rotarix doses have been contaminated with an apparently benign pig virus.

FDA Commissioner Margaret Hamburg says Rotarix has been used in millions of children worldwide — and 1 million in the U.S. — with no signs of safety problems. Nor is the pig virus known to cause any kind of illness in people or animals. But vaccines are supposed to be sterile, so FDA is investigating.

Meanwhile, FDA told doctors to use a competing vaccine against diarrhea-causing rotavirus, Merck’s Rotateq.