FRIDAY, June 20, 2014 (HealthDay News) -- The growing unease
around the safety of testosterone supplements was highlighted
Friday with a U.S. Food and Drug Administration announcement that
the products must now carry a warning label on the general risk of
blood clots in the veins.
Testosterone therapy has been widely advertised as a way to help
aging men with so-called "low T" improve their sex drive and
reclaim diminished energy. The products already carry a warning
about the 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.
In its statement Friday, the FDA said that after receiving
reports of blood clots in the veins unrelated to polycythemia in
patients taking testosterone products, it has now decided to
require a more general warning on venous blood clots on the
Blood clots in the veins include deep vein thrombosis (DVT) and
pulmonary embolism, a potentially life-threatening event that
occurs when a clot travels to the lungs. DVTs -- clots found
typically in the legs -- have gained attention in recent years due
to clots forming in passengers taking long-haul air flights.
Friday's warning about the risk of blood clots in the veins is
not related to the FDA's ongoing investigation into the risk of
stroke, heart attack and death in those taking testosterone
products, the agency said.
In February, the FDA announced that it would launch a broad
review of the therapies' safety, triggered by a study that
suggested that the treatments might raise men's heart risk.
"FDA is investigating the risk of stroke, heart attack and death
in men taking FDA-approved testosterone products," the agency said
in a statement released at the time. "We have been monitoring this
risk and decided to reassess this safety issue based on the recent
publication of two separate studies that each suggested an
increased risk of cardiovascular events among groups of men
prescribed testosterone therapy."
The FDA also advised that doctors "should consider whether the
benefits of FDA-approved testosterone treatment is likely to exceed
the potential risks of treatment."
Testosterone therapy typically is given in gel, patch or
injection form, and is widely promoted in television ads about "low
T." The treatments have been marketed so successfully that the
independent medicine website Drugs.com reported that sales of
Androgel exceeded sales of Viagra in 2013, according to UCLA
Right now, the FDA has only approved certain testosterone
products for use in men with low testosterone levels due to a
medical condition, such as inadequate testosterone production by
the testicles due to genetic defects or chemotherapy.
To learn more about low testosterone, visit the
Urology Care Foundation.