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Adverse effects of testosterone supplementation may include increased cardiovascular events (including strokes and heart attacks ) and deaths based on three peer-reviewed studies involving men taking testosterone replacement. [51] In addition, an increase of 30% in deaths and heart attacks in older men has been reported. [52] Due to an increased incidence of adverse cardiovascular events compared to a placebo group , a Testosterone in Older Men with Mobility Limitations (TOM) trial (a National Institute of Aging randomized trial) was halted early by the Data Safety and Monitoring Committee . [53] On January 31, 2014, reports of strokes , heart attacks , and deaths in men taking FDA-approved testosterone-replacement led the FDA to announce that it would be investigating the issue. [54] Later, in September 2014, the FDA announced, as a result of the "potential for adverse cardiovascular outcomes", a review of the appropriateness and safety of Testosterone Replacement Therapy (TRT). [55] [56] [57] The FDA now requires warnings in the drug labeling of all approved testosterone products regarding deep vein thrombosis and pulmonary embolism . [58]

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