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On June 19, the Food and Drug Administration (FDA) announced that it was requiring manufacturers of all approved testosterone products to include a general warning on the product labeling about the risk of developing blood clots in veins.[1] These clots, also known as venous thromboembolism, often form in the large veins in the legs. They can break off, go to the lungs and block blood vessels there, which can be fatal.
Although this new warning for testosterone products is...
On June 19, the Food and Drug Administration (FDA) announced that it was requiring manufacturers of all approved testosterone products to include a general warning on the product labeling about the risk of developing blood clots in veins.[1] These clots, also known as venous thromboembolism, often form in the large veins in the legs. They can break off, go to the lungs and block blood vessels there, which can be fatal.
Although this new warning for testosterone products is appropriate, it is dangerously incomplete. The FDA inexplicably continues to drag its feet by failing to also require prominent warnings on the drug labels of all testosterone products about the increased risk of heart attacks and other dangerous cardiovascular events caused by blood clots in arteries.
In the March issue of Worst Pills, Best Pills News, Public Citizen’s Health Research Group summarized the accumulating evidence of an association between testosterone therapy and serious adverse cardiovascular events related to the formation of clots in arteries, including heart attacks and strokes.[2] The evidence includes data from randomized clinical trials and from recently published large observational studies. On Feb. 25, shortly after that issue went to press, we petitioned the FDA to immediately add a black-box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S.[3] The FDA has not yet acted on our petition.
In its June 19 announcement, the FDA noted that the risk of blood clots in veins was 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 in people using testosterone. The agency decided to add the general warning because there have been reports of blood clots in veins unrelated to polycythemia in patients taking testosterone. The FDA went on to state that it is still evaluating the possible risks of heart attack and stroke — which are related to blood clots in the arteries — in patients taking testosterone products.
The available evidence linking testosterone use to heart attacks and other dangerous cardiovascular events caused by blood clots in arteries is far stronger than that cited by the FDA linking the drug to clots in veins. Thus, the FDA’s continued failure to mandate strong warnings about the heart attack and stroke risks for testosterone in the face of aggressive direct-to-consumer promotion and widespread overprescribing is inexcusable and represents a betrayal of the FDA’s role as an agency in the U.S. Public Health Service.
References
[1] Food and Drug Administration. FDA adding general warning to testosterone products about potential for venous blood clots. June 19, 2014. http://www.fda.gov/Drugs/DrugSafety/ucm401746.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed June 22, 2014.
[2] Testosterone Use Linked to Increased Risk of Heart Attacks. Worst Pills, Best Pills News. March 2014. /newsletters/view/891. Accessed June 22, 2014.
[3] Wolfe S, Carome M. Petition to the FDA to add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs presently on the market in the U.S. February 25, 2014. http://www.citizen.org/hrg2184. Accessed June 22, 2014.
