Rotavirus vaccine may be linked to more cases of bowel disorder
BETHESDA, MD,(Reuters Health) – The Food and Drug Administration (FDA) has received reports of 99 cases of intussusception that may be related to RotaShield rotavirus vaccine, an FDA medical officer said Tuesday.
Intussusception, where part of the bowel telescopes into an adjacent part, most commonly occurs in infants and young children. The disorder causes bowel obstruction, and often requires surgery.
Two of the 99 children experiencing the bowel obstruction died, said FDA’s Kathryn Carbone, one of the initial reviewers of the RotaShield data. All had been given at least one dose of RotaShield, an oral vaccine meant to inhibit infection with the diarrhea-causing rotavirus.
RotaShield, approved in August 1998, was hailed as a life-saver.
On July 17, the Centers for Disease Control and Prevention (CDC) urged physicians and parents to hold off on rotavirus vaccination until investigators could determine whether RotaShield was causing intussusception.
The Association of American Physicians and Surgeons urged Congress on September 2 to start an inquiry into the FDA’s vaccine approval process, claiming that the RotaShield approval may indicate deeper problems with the system.
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