FDA Requires New Warning on Testosterone Products

A new warning label featuring the risk of venous blood clots must now be included by manufacturers on approved testosterone products, according to the U.S. Food and Drug Administration (FDA).

The FDA currently monitors men using testosterone products for risk of mortality, heart attack, and stroke, and while venous blood clots are already listed on the warning labels of testosterone products as a possible cause of polycythemia, the FDA revealed that there are reports of manifested clots unrelated to polycythemia.
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This warning is unrelated to the current FDA investigation into the risk of stroke and heart attack in men using testosterone products.

Testosterone products are approved for use in men with low testosterone in addition to various medical conditions and causes, including genetics or chemotherapy.

-Michelle Canales

Reference:

The U.S. Food and Drug Administration. FDA adding general warning to testosterone products about potential for venous blood clots [press release]. June 19, 2014. http://www.fda.gov/drugs/drugsafety/ucm401746.htm. Accessed June 20, 2014.