Hi mummies, pls note:
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Vaccine Draws FDA Warning
By ANNA WILDE MATHEWS and JOHN CARREYROU
February 14, 2007
The Food and Drug Administration warned that 28 infants had suffered from a potentially deadly intestinal condition after taking Merck & Co.'s RotaTeq, but the agency said it doesn't know if the incidents were connected to the vaccine.
There have been 3.5 million doses of the vaccine -- given to prevent the viral infection rotavirus -- distributed in the U.S. since its approval last February, though not all of them have been administered. The FDA said this doesn't exceed the normal background rate of the intestinal condition, called intussusception, in which the intestine gets blocked or twisted.
But the issue is likely to draw attention because a previous rotavirus vaccine, made by Wyeth, was pulled from the market in 1999 after it was linked to intussusception. It is a particular challenge for Merck, which has used a string of recent approvals of high-profile vaccines to emerge from the shadow of the 2004 withdrawal of the painkiller Vioxx for safety reasons.
FDA WARNING
The FDA warned that 28 cases of intussusception were reported after RotaTeq was issued and encouraged parents to report other possible cases. Read the FDA warning.
Rotavirus can cause diarrhea, vomiting and fever and leads to some hospitalizations, but it is rarely fatal in the U.S. The FDA said the 28 new cases of intussusception had been reported to a system that tracks adverse events potentially tied to vaccines. All of the infants survived -- 16 got surgery on their intestines, and 12 had the condition eased by an enema or other means.
The agency said it was issuing the warning, posted on its Web site, in order to encourage reporting of the condition and to "remind people that intussusception is a potential complication of RotaTeq."
Michelle Goveia, medical director of pediatric medical affairs at Merck, said the company continues to believe that the vaccine should be administered to all children. A continuing Merck study of RotaTeq involving 44,000 children "shows nothing of concern to date," she said, but the full results of that study won't be known until late 2008.
Merck said it updated the prescribing information for RotaTeq to include the 28 cases of intussusception reported.
Merck, of Whitehouse Station, N.J., has said that world-wide sales of RotaTeq reached $163 million last year. Some analysts have forecast that the vaccine could reach $500 million in sales by 2009.
A spokesman for the Centers for Disease Control and Prevention said the agency hadn't changed its recommendation that infants receive Merck's RotaTeq and is "closely monitoring" the product, as it does all new vaccines.
Before winning FDA approval, Merck did a four-year, $350 million study of RotaTeq in about 70,000 patients, and "no significant increased risk of intussusception was found," the FDA said.
Paul Offit, a co-inventor of RotaTeq and the head of infectious diseases at Children's Hospital of Philadelphia, said the 28 cases of intussusception reported so far are "well less than what would be expected." The condition develops spontaneously in unvaccinated children ages six to 35 weeks at a rate of 18 to 43 per 100,000 a year, according to the FDA.