(Reuters) - The asthma drug Xolair is associated with a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems, though the extent of increased risk is unclear, the U.S. Food and Drug Administration said on Friday.
The FDA said it has added information about the increased risk to the drug’s label after analyzing findings from a five-year safety study submitted by the drug’s manufacturer, Genentech, a unit of Roche Holding AG, and 25 clinical trials comparing Xolair to a placebo.
Xolair is an injectible drug that was originally approved in 2003 to treat moderate to severe asthma in adults and children aged 12 or over whose condition was not controlled by inhaled steroids.
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