The Food and Drug Administration said today it was notifying healthcare providers and consumers about reports of some 28 cases of infants suffering a serious bowel condition after receiving Merck & Co’s new vaccine against the rotavirus.
The FDA said it was not immediately clear how many of the cases were caused by the vaccine. It said the condition, known as intussusception, can occur in the absence of vaccination.
About 3.5 million doses of Merck’s RotaTeq have been distributed in the United States since its approval in February 2006, the FDA said.
The agency said the 28 reported cases do not exceed the number that might be expected, but it issued the warning to encourage reports of any additional cases.
The agency also said it was issuing the notification, which also was posted on the FDA Web site, to remind people that intussusception was a potential complication of RotaTeq.
The potentially life-threatening condition occurs when the intestine gets blocked or twisted and one portion telescopes into a nearby portion, causing an intestinal obstruction.
Merck said on Tuesday it had updated the prescribing information on the vaccine’s label insert to include post-marketing reports of intussusception and hematochezia, or bleeding from the intestines, to the Vaccine Adverse Events Reporting System, a national vaccine safety surveillance program.
Intussusception causes intense abdominal pain. Most infants who are treated within 24 hours recover completely but a delay in treatment can result in serious complications, including tissue damage, perforation of the bowel, and death.
The bowel problem spurred the recall in 1999 of Wyeth’s RotaShield vaccine against rotavirus.
In order to reduce your chances of getting rotavirus health professionals recommend hand washing.
Be sure to wash your hands frequently and sanitize any surface that you use for diapering. If your child attends child care, check to make sure that proper handwashing and sanitation procedures are being followed, which includes washing hands for those who are potty training after each bathroom use.
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