Media contact:
Trish Parnell
Executive Director

Email: pkids@pkids.org

Voice: 360.695.0293
Fax: 360.695.6941

RotaTeq: What the FDA Said
February 2007

The Food and Drug Administration (FDA) recently released a notice to healthcare providers and consumers that over the past 12 months, “28 cases of intussusception have been reported in the U.S. in infants who received RotaTeq,” a vaccine used to prevent rotavirus.

This statement does not mean that the vaccine caused those cases of intussusception. What has been overlooked in the reporting of this notice (Re “Intestinal Woes, Vaccine May Be Linked,” Feb. 14) is that, according to the CDC unpublished data referred to in the FDA’s statement, there are between 700 and 1700 cases of intussusception that occur annually in unvaccinated babies ages 6 to 35 weeks. In other words, intussusception occurs in babies and it occurs at about the same time as the vaccine is given.

Rotavirus infection is a nasty viral infection that is easily spread and can cause severe diarrhea and dehydration in babies. Annually, there are 55,000 to 70,000 hospitalizations in children under the age of five in the U.S. due to rotavirus infection and 20 to 60 children die. It’s a serious infection.

Before we go scaring parents half to death, let’s make sure of our facts.
The FDA isn’t saying there’s causation, it’s saying let’s pay attention and watch for any side effects. We all want what’s best for our kids and we need to approach their healthcare with reason and thoughtfulness.

Trish Parnell
Director
PKIDs (Parents of Kids with Infectious Diseases)

Important disclaimer: The information on pkids.org is for educational purposes only and should not be considered to be medical advice. It is not meant to replace the advice of the physician who cares for your child. All medical advice and information should be considered to be incomplete without a physical exam, which is not possible without a visit to your doctor.