The FDA announced that it is now requiring a general warning in the drug labeling of all approved testosterone products regarding the risk of venous blood clots unrelated to polycythemia.

This requirement is due to postmarket reports of venous blood clots unrelated to polycythemia; the risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia. The FDA is continuing to evaluate the possible risk of stroke, heart attack, and death in patients taking testosterone products.

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FDA-approved testosterone products are indicated for use in men as testosterone replacement therapy, who lack or have low testosterone levels in conjunction with an associated medical condition such as hypogonadism due to genetic issues or chemotherapy.

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