Forest's COPD Drug May Have Added Heart Risks: FDA

Law360, Washington (February 21, 2012, 7:16 PM EST) -- A U.S. Food and Drug Administration staff report Tuesday noted the effectiveness of a proposed Forest Laboratories Inc. chronic obstructive pulmonary disease drug, but brought up concerns that the drug could raise the risk of heart problems.

The review, which the FDA prepared for an upcoming pulmonary allergy drugs advisory panel review of Forest's aclidinium bromide, focused on an increased number of cardiovascular-related deaths in clinical trial patients treated with the inhaled drug compared with placebo patients. The panel will determine whether to recommend agency approval...
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