FDA says Merck vaccine linked to bowel problem

NEW YORK (Reuters) - The U.S. Food and Drug Administration said it was notifying healthcare providers and consumers about reports of 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 28 reported cases were caused by the vaccine. It said the condition, known as intussusception, can occur in the absence of vaccination.

Some 3.5 million doses of Merck's RotaTeq have been distributed in the United States since its approval last February, 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 becomes blocked or twisted, causing an obstruction.

The same problem spurred the recall in 1999 of Wyeth's RotaShield vaccine against rotavirus, which causes serious diarrhea and is a leading cause of hospitalization for infants.

Intussusception causes intense abdominal pain. Most infants who are treated within 24 hours recover completely. A delay in treatment can result in serious complications, including tissue damage, perforation of the bowel and death.