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.
What This Means to You
Talk to your doctor if you have concerns about RotaTeq or any other vaccine. Again, it's important to remember that this report from the FDA doesn't show that there is an increased risk of intussusception in children after receiving the rotavirus vaccine — the report was issued to make sure that doctors and others report all cases of intussusception to ensure that there is not an increased risk associated with the vaccine. Immunizations protect against serious illnesses like rotavirus, so it's important that kids be vaccinated on schedule.
Rotavirus infection is a major cause of sickness in infants and young children. In the United States, it infects 4 out of 5 kids by the age of 5 with the "stomach flu," causing diarrhea and dehydration (also known as gastroenteritis). Each year the infection accounts for roughly 3 million cases of diarrhea, 55,000 hospitalizations, and several deaths due to severe dehydration and other complications.
Rotavirus infections are extremely contagious. They're usually passed along when kids put their fingers in their mouths after touching something that has been contaminated by infected feces (poop). Parents and health-care and child-care workers can also spread the virus, especially if they don't wash their hands after changing diapers.
Signs of a rotavirus infection include fever, nausea, and vomiting often followed by abdominal cramps, and watery diarrhea that can cause dehydration. Kids with diarrhea should be kept home from child-care, playgroups, or school until the diarrhea has stopped. If you're caring for a child with diarrhea, wash your hands often, particularly after going to the bathroom or changing diapers, when caring for another child, and before preparing and serving food.
If your child recently received the rotavirus vaccine, call your doctor right away if you see signs of intussusception, which include stomach pain, vomiting, diarrhea, bloody stools (poop), or a change in bowel movements.
Reviewed by: Steven Dowshen, MD
Date reviewed: February 2007
