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.

2 Responses to “FDA: Risk for Venous Thromboembolism with All Testosterone Products”

  1. Its likely due to increased estrogen levels. Estradiol should be between 20 pg/ml and 30 pg/ml in males testosterone replacement patients. Estrogen can be lowered by giving anastrozole (Arimidex) 0.5 mg q 7days. In 11 years of managing patients on testosterone I have never seen a DVT but I am sure they do happen. Factors known to increase aromatase activity include increased age, obesity, elevated insulin (insulin resistance), gonadotropins, and alcohol.

  2. apart from these valid factors, the route of administration also matters. testosterone being liable to high first pass metabolism, gets rapidly converted to estradiol & hence low systemic Bioavailability.

    the orally adminstered preparations of testosterone are usually dosed keeping in view of this kinetics.

    therefore, topical testosterone patches could be safe, in respect of occurence of VTE.