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FDA Issues Drug Safety Communication for Testosterone

On March 3, 2015, the FDA issued a Drug Safety Communication concerning Testosterone drugs. Based on published studies and expert input from an Advisory Committee meeting, the FDA concluded that there is a possible increased cardiovascular risk associated with testosterone drugs and that some studies report an increased risk of heart attack, stroke and death associated with testosterone drugs. As a result, the FDA is requiring labeling changes for all prescription testosterone drugs to reflect the potential increased risk of heart attacks and strokes from the use of testosterone products. The timing of the FDA’s announcement is noteworthy as more than 1,100 Testosterone lawsuits are pending against the manufacturers of Testosterone drugs.

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