According to a Reuters report, the Food and Drug Administration stated that it would be notifying consumers and health care providers alerting them to some 28 cases where infants suffered serious bowel conditions after receiving Merck's new vaccine to protect against rotavirus.
The report from Reuters said, The FDA said it was not immediately clear how many of the 28 reported cases were caused by the vaccine. It said the condition, known as intussusception, can occur in the absence of vaccination.
The FDA said at least 3.5 million doses of Merck's vaccine have already been delivered in the United States since its release in February of 2006. The FDA said that the 28 cases filed with the agency is not enough to recall the vaccine, but they have issued a warning and are waiting to hear of any further cases to be reported.
Intussusception is the intestines get blocked or twisted, resulting in one portion to telescope into another portion causing intestinal blockage. This causes very strong abdominal pain and if not treated with the first 24 hours, can cause permanent damage to the abdominal tissue or even death.
Dr. Michelle Goveia told Reuters, it would be difficult to determine how many, if any, of the 28 cases of intussusception reported under the surveillance system were due to the Merck vaccine. But she speculated most were naturally occurring cases, given the product's safety in the large clinical trials.
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New Merck Vaccine Produces Serious Bowel Problems for Infants
By : info@epharmacies.com
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Keywords:
vaccine cases