Warning on diarrhea vaccine for infants

Warning on diarrhea vaccine for infants
Twisting of intestines reported after babies received rotavirus shots

WASHINGTON - The government warned doctors and parents Tuesday of reports of potentially life-threatening twisting of the intestines in infants vaccinated against a virus that is the leading cause of early childhood diarrhea.

The condition, called intussusception, is the same that led to the withdrawal of the first rotavirus vaccine eight years ago.

The Food and Drug Administration said it was unknown whether the recently approved vaccine, called RotaTeq, caused the 28 new cases. The condition also can occur spontaneously.

Still, the agency said it was issuing the warning in part to encourage reporting of any additional cases of intestinal twisting or blockage to help it assess any risks associated with the three-shot vaccine series.

The vaccine’s manufacturer, Merck & Co. Inc., didn’t immediately return a call seeking comment.

The 28 cases included 16 infants who required intestinal surgery. There have been no reports of deaths.

RotaTeq received FDA approval in February 2006. At the time, the FDA and Merck said trials of the vaccine indicated it did not increase the risk of intussusception. But Merck and the Centers for Disease Control and Prevention are conducting follow-up studies of tens of thousands of infants to track any long-term effects of the vaccine. The FDA also is monitoring reports.

About 3.5 million doses of the Merck vaccine have been distributed in the U.S., though not all have been used, the FDA said.

The earlier rotavirus vaccine, Wyeth’s RotaShield, was pulled from the U.S. market in 1999 after it was linked to a small increase in intussusception.

In the United States, rotavirus sickens about 2.7 million children younger than 5, sends up to 70,000 to the hospital and causes 20 to 70 deaths each year.