FDA Notes Baby Vaccine Bowel Problems
Serious Bowel Problems Reported in 28 U.S. Babies After Getting RotaTeq Vaccine
WebMD News Archive
Reported Cases continued...
Those studies showed "no significant increased risk of
intussusception," notes an FDA public health notice.
The FDA also says that "the number of intussusception cases reported to
date after RotaTeq administration does not exceed the number expected,"
based on unpublished CDC data.
According to the FDA, about 3.5 million doses of RotaTeq had been
distributed in the U.S. through Feb. 1, 2007, but not all of those doses have
The 28 intussusception cases were reported after the first, second, and
third doses of the vaccine. The cases occurred within 73 days after getting any
of those doses; roughly half of the cases happened within 21 days.
The FDA's Past Comments
When the FDA approved RotaTeq just over a year ago, the FDA's Jesse Goodman,
MD, MPH, called data from the vaccine's preapproval studies
But Goodman, who directs the FDA's Center for Biologics Evaluation and
Research, also said at the time that "people would need to consider that
[the studies] are not conclusive that this side effect could not potentially
occur" and that the FDA had put in place "an extremely aggressive
program to try to get as much information about the vaccine in its early period
of use as possible."
Further studies are being done to probe the risk of intussusception and
other serious events with RotaTeq.
RotaTeq's maker, the drug company Merck, is conducting a postmarketing study
of approximately 44,000 infants. The CDC is doing its own study of about 90,000
infants, says the FDA. Merck is a WebMD sponsor.
WebMD contacted Merck for the company's comments.
In a news release emailed to WebMD, Merck states that intussusception is
"a naturally occurring event in infants" that is estimated to occur in
approximately one in 2,000 infants during the first year of life.
"Cases of intussusception can occur when no vaccine has been given, and
the cause is usually unknown," Merck states.
The news release also includes comments from Mark Feinberg, MD, PhD, vice
president of policy, public health, and medical affairs for Merck Vaccines.
"It is common for post-marketing experience information with a vaccine
to be reported to VAERS and for the prescribing information to be updated
accordingly," Feinberg says, in the news release.
Feinberg says public health and patient safety are Merck's "highest
priorities" and that Merck is "very confident" in the data
supporting RotaTeq's safety profile from its preapproval study.
RotaShield, the vaccine that was withdrawn from the market in 1999, was made
by the drug company Wyeth.
Wyeth is a WebMD sponsor.