FDA Tweaks Cancer Drug Warnings Over Hypertension Risk

Law360, New York (October 11, 2011, 7:52 PM EDT) -- The U.S. Food and Drug Administration announced Tuesday that it had amended the warning labels of Bristol-Myers Squibb Co.'s leukemia drug Sprycel to reflect the potential risk of patients developing abnormally high blood pressure in their lung arteries.

To warn the public about this “rare but serious” side effect, the FDA added the risk to the warnings and precautions section of the Sprycel drug label and circulated a safety communication warning to the public about the drug's link to this condition, known as pulmonary arterial hypertension,...
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