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FDA Sees Bowel Risk In Rotavirus Vaccine Data

Posted Sep 24 2010 12:00am

Intussusception Rotavirus vaccines have been plagued with this side effect called intussusception - where one portion of the bowel slides into another like a telescope (HERE)  causing great pain and leading to the point where the infant can die from bowel obstruction. Dr. Paul Offit is a patent holder on Merck's RotaTeq virus. This article from Reuters is about the Glaxo version of the vaccine.

WASHINGTON | Wed Sep 22, 2010 9:11pm IST

WASHINGTON (Reuters) - GlaxoSmithKline Plc's rotavirus vaccine may be linked to a small increase in a life-threatening type of bowel obstruction, U.S. health officials said on Wednesday.

Early data from a study in Mexico suggested infants given the Rotarix vaccine may face a higher chance of an intestinal problem known as intussusception in the 31 days after their first dose, the Food and Drug Administration said on its website.

"Although the results are preliminary and will require further evaluation, FDA approved revised labeling to inform healthcare providers of this finding," the agency said.

Rotavirus is the world's leading cause of severe diarrhea and dehydration in young infants. The benefits of rotavirus vaccines continue to outweigh risks, the FDA said.

Glaxo's rotavirus vaccine sales in 2009 were $440 million globally, including $118 million in the United States.

The British drug company's shares slipped 0.7 percent to $40.06 in morning trading on the New York Stock Exchange.

(Reporting by Lisa Richwine; Editing by Maureen Bavdek)

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