Warning on diarrhea vaccine for infants - Kids & Parenting - MSNBC.com
Source: MSNBC NEWS Author: MSNBC NEWS Published date: 2008-02-23
Clicks:
Warning on diarrhea vaccine for infants Twisting of intestines reported after babies received rotavirus shots
WASHINGTON - The government warned on Tuesday of potentially life-threatening twisting of the intestines in infants vaccinated against a virus that is the leading cause of early childhood diarrhea.
The condition, called intussusception, is the same that led to the withdrawal of the first rotavirus vaccine eight years ago.
The Food and Drug Administration said it was unknown whether the recently approved vaccine, called RotaTeq, caused the 28 new cases. The condition also can occur spontaneously. Indeed, the reports don't exceed the numbers expected to occur naturally each year - the so-called background rate, the FDA said.
"It looks like this is the natural background rate that we are seeing," said Dr. Michelle Goveia, medical director for pediatric medical affairs at the vaccine's manufacturer, Merck & Co. Inc. Goveia suggested heightened concerns about the previous vaccine, made by Wyeth, prompted the FDA to act.
In Tuesday's public health notification, the agency said it wanted in part to encourage reporting of any additional cases of intestinal twisting or blockage to help it assess any risks associated with the three-shot vaccine series. It also said the vaccine's label would mention the cases of intussusception.
"It's a known serious, life-threatening adverse event that is being seen at an expected level postmarketing. But because it is so serious, we asked the company to change the label," FDA spokeswoman Karen Riley said.
Dr. Paul Offit, the vaccine's co-inventor, said the 28 reports were well below the hundreds of cases one would expect naturally. He suggested the FDA wanted to "shake the tree" for more reports about the vaccine.
"I am actually encouraged by those data: 28 cases, when you would have expected at least 500 cases, that is really reassuring," said Offit, of the Children's Hospital of Philadelphia. "I don't see how those numbers suggest something's awry. If anything, they suggest nothing's awry."
The 28 cases included 16 infants who required intestinal surgery. There have been no reports of deaths.
Note: This site does not provide medical or any other health care or fitness advice, diagnosis, or treatment. The site and its services, including the information above, are for informational purposes only and are not a substitute for professional medical or health advice, examination, diagnosis, or treatment. Always seek the advice of your physician or other qualified health professional before starting any new treatment, making any changes to existing treatment, or altering in any way your current exercise or diet regimen. Do not delay seeking or disregard medical advice based on information on this site. Medical information changes rapidly and while Health Center and its content providers make efforts to update the content on the site, some information may be out of date. No health information on Health Center, including information about herbal therapies and other dietary supplements, is regulated or evaluated by the Food and Drug Administration and therefore the information should not be used to diagnose, treat, cure, or prevent any disease without the supervision of a medical doctor.
