Catharine Paddock
15 February 2007
Medical News Today
The FDA has issued a public health notice to health professionals and consumers
about the rotavirus vaccine RotaTeq.
It has received 28 reports on infants getting intussusception after being
vaccinated with RotaTeq (Live, Oral, Pentavalent vaccine against Rotavirus)
since the vaccine was licensed in February last year.
The vaccine prevents rotavirus gastroenteritis, the major cause of diarrhea and
vomiting in young children worldwide. The infection is highly contagious and can
cause severe dehydration (loss of body fluids) and even death.
So far, 3.5 million doses of RotaTeq, which is manufactured by Merck, have been
distributed in the United States, not all of which have been administered.
Intussusception is a serious life threatening condition where part of the bowel
collapses into a neighbouring part, rather like when a section of a collapsible
telescope pushes into another. This results in the bowel becoming blocked or
twisted.It usually happens where the small intestine joins the large intestine.
The FDA says it is issuing the notice to remind people that intussusception is a
potential complication of the RotaTeq vaccine, and to encourage them to report
cases of intussusception so that the FDA and the Centers for Disease Control and
Prevention (CDC) can assess the risks associated with the vaccine.
They would like US healthcare professionals and others to report any cases of
this or other adverse events associated with RotaTeq to the Vaccine Adverse
Events Reporting System (VAERS).
If your child has stomach pain, vomiting and diarrhea, there is blood in the
child's stool or changes in bowel movements, these could be signs of
intussusception and you should tell the doctor straight away.
The FDA says that intussusception can occur spontaneously in the absence of
vaccination and they do not know whether any of the 28 reported cases were
caused by RotaTeq or just coincidence.
Of the 28 cases reported so far, about half of them occurred within 21 days of
vaccination and 16 of the infants had to have surgery. The other children were
treated without surgery, using enemas. No deaths were reported.
Before it was licensed, RotaTeq was tested in a clinical trial involving 70,000
children, where half received the vaccine and half received a placebo. No
significant increase of intussusception risk was found. For instance 6 cases
occurred in the RotaTeq patients and 5 in the placebo group.
However, the FDA says that another rotavirus vaccine which is no longer
available may have been the cause of the increase in cases of intussusception,
which is why it is important to gather the post-marketing data from patients.
Two post-marketing studies are also being conducted, one by the manufacturer of
RotaTeq, Merck with 44,000 infants, and the other by the CDC Vaccine Safety Data
Link, with 90,000 infants.
Article URL: http://www.medicalnewstoday.com/articles/63074.php