FDA asks for more warnings on Testosterone products

The U.S. Food and Drug Administration said that all manufacturers of testosterone products in the market should include general warning in the labeling of the drug about the risk of blood clots in veins. While testosterone products already carry warning regarding a risk of clots associated with polycythemia, which involved an abnormal increase in red blood cells after use of such supplements.

The FDA stated that this new warning, a class labeling change, is not related to an ongoing FDA evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. The mandated warning comes due to the potential risk of cardiovascular events, which are related to blood clots in the arteries, seen in two separate studies among groups of men prescribed testosterone therapy.

The FDA also mentioned that blood clot occurring in the veins has now extended to deep vein thrombosis (DVT), which can form in passengers on long airplane flights, and pulmonary embolism (PE), a potentially life-threatening condition in which a clot reaches the lungs. DVT can develop into PE if a loose clot travels to an artery in the lungs and blocks blood flow, probably damaging the lungs, and other organs in the body, leading to death.The testosterone treatments that can be administered in gel, patch or injection form, are approved for use by the FDA in men suffering from inadequate hormone production due to genetic defects or chemotherapy.