FDA sees bowel risk in early Glaxo vaccine data
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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