FDA Drug Safety Podcast: FDA adding general warning to testosterone products about potential for venous blood clots

Welcome to the FDA Drug Safety Podcast for healthcare professionals from the Division of Drug Information. Today’s topic: FDA adding general warning to testosterone products about potential for venous blood clots.

On June 19, 2014, FDA announced it is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins, also known as venous thromboembolism, including deep vein thrombosis and pulmonary embolism. The risk of venous blood clots is already included 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. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to the labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure that this risk is described consistently in the labeling of all approved testosterone products.

Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. We are currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and described in the January 31st, 2014 Drug Safety Communication.

Thank you for listening. Adverse reactions involving testosterone products can be reported to the FDA’s MedWatch program at www.fda.gov/medwatch. A link to the full statement can be found atwww.fda.gov/DrugSafetyCommunications.

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