Watch for Intussusception After RotaTeq Vaccination, Says FDA
Report Suspected Cases
By News Staff
2/26/2007
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
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Earlier Vaccine Withdrawn
The issue was slated for discussion at ACIP's Feb. 21-22 meeting in Atlanta.
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FDA Public Health Notification: Information on RotaTeq and Intussusception
CDC Statement: Intussusception & RotaTeq Vaccine
RotaTeq Package Label
(PDF file: 10 pages / 161 KB. More about PDFs.)
WHO Global Advisory Committee on Vaccine Safety: Safety of Rotavirus Vaccines
Vaccine Adverse Event Reporting System








