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Another concern has recently come to light—an increased risk of potentially life-threatening blood clots in the veins, known as venous thromboembolism. This risk of venous thrombolembolism is discussed in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. However, there have been more recent reports of venous thromboembolism unrelated to polycythemia, and last summer, the FDA began requiring that manufacturers add a warning about this risk to all testosterone replacement therapy product labels.
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