Fwd: Merck RotaVirus Vaccine linked to 28 reports of life-threatening effect

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http://news./s/ap/20070213/ap_on_he_me/rotavirus_vaccine_1

FDA warns of vaccine complications

By ANDREW BRIDGES, Associated Press Writer1 hour, 32 minutes ago

The government warned doctors and parents Tuesday of reports 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. Still, the agency said it was issuing the

warning 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.

The vaccine's manufacturer, Merck & Co. Inc., didn't immediately return a

call seeking comment.

The 28 cases included 16 infants who required intestinal surgery. There have

been no reports of deaths.

RotaTeq received FDA approval in February 2006. At the time, the FDA and

Merck said trials of the vaccine indicated it did not increase the risk of

intussusception. But Merck and the Centers for Disease Control and

Prevention are conducting follow-up studies of tens of thousands of infants

to track any long-term effects of the vaccine. The FDA also is monitoring

reports.

About 3.5 million doses of the Merck vaccine have been distributed in the

U.S., though not all have been used, the FDA said.

The earlier rotavirus vaccine, Wyeth's RotaShield, was pulled from the U.S.

market in 1999 after it was linked to a small increase in intussusception.

In the United States, rotavirus sickens about 2.7 million children younger

than 5, sends up to 70,000 to the hospital and causes 20 to 70 deaths each

year.

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On the Net:

Food and Drug Administration notification on RotaTeq:

http://www.fda.gov/cber/safety/phnrota021307.htm

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