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FDA Notes Baby Vaccine Bowel Problems

Serious Bowel Problems Reported in 28 U.S. Babies After Getting RotaTeq Vaccine
By
WebMD Health News
Reviewed by Louise Chang, MD

Feb. 13, 2007 -- The FDA today announced that 28 U.S. babies reportedly developed a potentially deadly bowel problem after getting the RotaTeq vaccine.

The babies developed intussusception, a serious and potentially life-threatening condition in which the intestine gets blocked or twisted.

Sixteen of the 28 babies required hospitalization and surgery. The other 12 needed enemas to reduce the intussusception. None died.

RotaTeq targets rotavirus, a leading cause of kids' diarrhea. The vaccine, approved by the FDA last year, is on the CDC's 2007 recommended child immunization schedule. It's given in three doses when babies are 2 to 6 months old.

It's not known whether RotaTeq caused the babies' intussusception. The number of reported cases is in line with expectations, says the FDA.

However, a different rotavirus vaccine, called RotaShield, was withdrawn from the market in 1999 after a rise in intussusception was noted after its use.

RotaTeq's label has been updated to reflect the intusssusception reports. But the vaccine's "dosage and administration schedule remains unchanged," says the FDA.

The FDA's Recommendations

The FDA's public health notification about the intussusception cases includes these recommendations:

"Parents should contact their child’s doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception. It is important to contact the child’s doctor if there are any questions or if the child has any of these symptoms at any time after vaccination, even if it has been several weeks since the last vaccine dose."

The FDA also asks that any cases of intussusception be reported to the Vaccine Adverse Event Reporting System (VAERS), which is run by the FDA and CDC.

For a copy of the vaccine reporting form, call 800-822-7967 or go online to www.vaers.hhs.gov.

Reported Cases

The 28 cases of intussusception were reported between the FDA's approval of RotaTeq on Feb. 3, 2006 and Jan. 31, 2007.

RotaTeq's intussusception risk was studied in approximately 70,000 infants -- half of whom got the RotaTeq vaccine; the other half got a placebo -- before the FDA approved RotaTeq.

Those studies showed "no significant increased risk of intussusception," notes an FDA public health notice.

The FDA also says that "the number of intussusception cases reported to date after RotaTeq administration does not exceed the number expected," based on unpublished CDC data.

According to the FDA, about 3.5 million doses of RotaTeq had been distributed in the U.S. through Feb. 1, 2007, but not all of those doses have been administered.

The 28 intussusception cases were reported after the first, second, and third doses of the vaccine. The cases occurred within 73 days after getting any of those doses; roughly half of the cases happened within 21 days.

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