Watch for Intussusception After RotaTeq Vaccination, Says FDA

Report Suspected Cases

By News Staff
2/26/2007

On Feb. 13, the FDA notified health care professionals and the public about 28 reports of intussusception after administration of live, oral, pentavalent rotavirus vaccine, marketed as RotaTeq. At this time, it is not known whether the vaccine caused some or all of these cases, although this incidence is consistent with what would be expected at baseline (i.e., in an unvaccinated population).

Of the 28 cases, 16 patients required hospitalization and surgery to clear the intussusception; 12 had the intestinal blockage cleared by contrast or air enema. No deaths were reported.

According to the FDA Public Health Notification, the agency issued the notice "both to encourage the reporting of any additional cases of intussusception that may have occurred or occur in the future after administration of RotaTeq and to remind people that intussusception is a potential complication of RotaTeq."

The FDA's action illustrates the value of the Vaccine Adverse Event Reporting System, or VAERS, says Jonathan Temte, M.D., Ph.D., associate professor in the family medicine department at the University of Wisconsin, Madison, and an AAFP liaison to the CDC's Advisory Committee on Immunization Practices, or ACIP.

Report Intussusception Cases

AAFP members can report suspected cases of intussusception to the Vaccine Adverse Event Reporting System online or by using any of several other reporting options.

A cooperative CDC/FDA postmarketing safety surveillance program that collects, analyzes and disseminates information about adverse events that occur after administration of U.S. licensed vaccines, VAERS "works exceedingly well for picking up rare events and appropriately responding to them," Temte notes.

The currently licensed rotavirus vaccine, which is given in a three-dose series at 2, 4 and 6 months, is included in the 2007 Recommended Immunization Schedule for Ages 0–6 Years (PDF file: 1 page / 89 KB. More about PDFs.) jointly developed by the ACIP, the AAFP and the American Academy of Pediatrics.

Earlier Vaccine Withdrawn

A different version of rotavirus vaccine, sold under the trade name RotaShield, was approved by the FDA in August 1998 and was recommended for widespread use in October 1998. That product -- an oral, live, tetravalent, rhesus-based vaccine -- was withdrawn one year later, following reports of intussusception associated with its use and a determination by the ACIP that the vaccine's risks outweighed potential benefits. Learn more by reading a CDC Fact Sheet. (PDF file: 4 pages / 59 KB. More about PDFs.)

AAFP members can be assured that the Academy, via its relationship with the ACIP, is following this issue closely, says Temte, and that further developments will be rapidly passed along as indicated. "At this time, there is no evidence to support a change in our recommendation for universal immunization of infants with the rotavirus vaccine," he adds.

The issue was slated for discussion at ACIP's Feb. 21-22 meeting in Atlanta.

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