FDA Issues Report About Rotavirus Vaccine and Intestinal Problem

FDA Issues Report About Rotavirus Vaccine and Intestinal Problem
The Nemours Foundation

As part of its routine monitoring, the U.S. Food and Drug Administration (FDA) issued a public health notification about reports of intussusception (a type of serious bowel blockage) that occurred after infants were given the recently approved rotavirus vaccine RotaTeq. The vaccine protects kids against rotavirus, the leading cause of diarrhea in babies and young children.

Approximately half of the 28 cases reported happened within 3 weeks of when the babies were given the vaccine. No deaths were reported, but 16 of the infants were hospitalized and required intestinal surgery.

Intussusception is a potentially life-threatening condition that occurs when one portion of the bowel slides into the next. This creates a bowel obstruction that leads to swelling, inflammation, and decreased blood flow to the intestines.

Note: According to the FDA many cases of intussusception happen “spontaneously” each year, with or without vaccination. And there’s no evidence indicating whether these new post-vaccination cases occurred naturally or can be linked to the vaccine.

The FDA issued the warning to make the public aware of a potential risk and to encourage doctors and parents to report all cases of intussusception following vaccination. The Centers for Disease Control and Prevention (CDC) and the company that makes RotaTeq will also be conducting follow-up studies to ensure that the vaccine is safe.

In October 1999, a rotavirus vaccine called RotaShield was taken off the market after being linked to an elevated risk of intussusception. After research showed no indication that RotaTeq increased the risk of intussusception, the FDA approved the new vaccine in 2006 and the American Academy of Pediatrics (AAP) added it to the list of vaccines it recommends for infants.

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