FDA Notes Baby Vaccine Bowel Problems

Serious Bowel Problems Reported in 28 U.S. Babies After Getting RotaTeq Vaccine


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However, a different rotavirus vaccine, called RotaShield, was withdrawn from the market in 1999 after a rise in intussusception was noted after its use.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

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