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FDA updates warning requirements for VTE on testosterone products
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The FDA is now requiring a general warning on the drug labels of testosterone products about the risk for venous thromboembolism associated with them.
The agency had previously required manufacturers to include a warning about risk for VTE, including deep vein thrombosis and pulmonary embolism, as a result of polycythemia, which can occur with testosterone treatment.
However, the agency became aware of postmarket reports of testosterone products being associated with VTE unrelated to polycythemia, and is now requiring a general warning about risk for VTE on all testosterone products.
The new warning is not related to the FDA’s investigation of the risk for stroke, MI and death in patients taking testosterone products, which concerns blood clots in the arteries.