Anti-Diarrheal Vaccine for Babies Recalled

Just a year after the government approved it, the world’s only vaccine against the leading cause of childhood diarrhea was pulled off the market Friday because of fears it might increase infants’ risk of a dangerous bowel obstruction.

The government advised doctors in July to stop vaccinating babies against rotavirus after counting 20 infants who developed bowel obstruction shortly after swallowing the vaccine.

An estimated 1 million U.S. infants had been vaccinated.

The government now has at least 99 reports of bowel obstruction that may be linked to the vaccine, so the manufacturer, American Home Products, has pulled its RotaShield vaccine off the market.

Any doctors who still have doses should return them to the manufacturer immediately.

Parents should not worry if their babies took RotaShield without problems, said Dr. Jesse Goodman of the Food and Drug Administration. Cases of the bowel obstruction, called intussusception, thought to be linked to RotaShield occurred within the first week or two after vaccination.

This type of bowel obstruction can occur by chance whether or not a baby ever had a rotavirus vaccine. One estimate suggests it strikes 50 of every 100,000 babies. Symptoms include vomiting, bloody stools and abdominal pain. Surgery often is needed.