FDA Requires Blood Clot Warning for Testosterone Products

The U.S. Food and Drug Administration (FDA) is mandating that manufacturers include a general warning on the drug labeling of all approved testosterone products, to advise of the risk of blood clots in the veins, according to a recent statement issued by the organization.

“The general warning is intended to communicate to prescribers and patients that the potential risk of venous blood clots associated with testosterone therapy exists independently of polycythemia, which is an abnormal increase in red blood cells that can occur with testosterone treatment,” says Kristofer Baumgartner, spokesperson with the FDA. “This information allows for informed decision making when deciding to use or continue to use testosterone therapy.”
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Primary care practitioners—as well as other prescribers of testosterone therapy—should continue to consider the benefits and risks of testosterone therapy, including the potential for venous blood clots for a given patient, says Baumgartner, adding that testosterone therapy would be appropriate if the benefits outweigh the risks in the individual patient.

The new warning is not related to the FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products, according to the organization, which is currently evaluating the potential risk of such cardiovascular events, which are related to blood clots in the arteries.

The warning also includes specific recommendations for the prescriber, such as a reminder to evaluate for venous blood clots in a patient using testosterone therapy who has symptoms of pain, swelling, warmth or redness in the leg, or sudden shortness of breath. The labeling also recommends that the prescriber discontinue the testosterone treatment and initiate appropriate workup and management if a venous blood clot is suspected.  

—Mark McGraw