sees bowel risk in early Glaxo vaccine data
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.
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.
the results are preliminary and will require further evaluation, FDA approved
revised labeling to inform healthcare providers of this finding," the
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.
rotavirus vaccine sales in 2009 were $440 million globally, including $118
million in the United States.
drug company's shares slipped 0.7 percent to $40.06 in morning trading on
the New York Stock Exchange.
by Lisa Richwine; Editing by Maureen Bavdek)