FDA Says Testosterone Therapies Need Blood Clot Warning Label

The FDA said it would require a warning label on all testosterone products detailing the general risks of developing blood clots in the veins.

Testosterone products already carry a warning about a risk of blood clots in the veins due to polycythemia, an abnormal rise in the number of red blood cells that sometimes occurs with testosterone treatment. However, the FDA said it has received postmarket reports of clotting unrelated to polycythemia, therefore deciding it needs a more general venous blood clot warning on labeling.

Blood clots in the veins include venous thromboembolism, deep vein thrombosis and pulmonary embolism, a potentially life-threatening event that occurs when a clot travels to the lungs.

The FDA said the new warning is not related to its ongoing investigation into the possible risk of heart attack, stroke and death linked to blood clots in the arteries in patients taking testosterone products.

Testosterone therapies are typically administered in gel, patch or injection form. The FDA is recommending that doctors "consider whether the benefits of FDA-approved testosterone treatment are likely to exceed the potential risks of treatment." — Kellen Owings

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.