June 23rd, 2014
FDA: Risk for Venous Thromboembolism with All Testosterone Products
The FDA is requiring an expanded label change to all approved testosterone products to warn of the increased risk for venous thromboembolism. Labels currently address the risk for clots associated with polycythemia caused by testosterone treatment.
The action follows reports of blood clots in testosterone users unrelated to polycythemia. The agency says the warning is not related to an ongoing investigation announced in January about possible cardiovascular risks associated with testosterone treatment.