Testosterone therapy is associated with a number of risks one of which is increased likelihood for a heart attack. Due to this particular risk, the U.S. Food and Drug Administration (FDA) is implementing a measure that would inform users and those who intend to use testosterone products about this danger.
On Thursday, the FDA announced that it now requires manufacturers of testosterone products to have a general warning in the labels to inform consumers about the risks of blood clots forming in the veins. The labeling currently found in testosterone products already includes risks of venous blood clots associated with polycythemia but the new protocol to include an additional blood clot risk is implemented because of reports of blood clots in the vein that are not associated with polycythemia.
Polycythemia is characterized by an abnormal increase in the concentration of the hemoglobin in the blood which can occur as a side effect of testosterone treatment. The condition makes the blood thicker and thus increases risks for a heart attack or stroke.
"FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products," the FDA said in a statement.
Men use testosterone products to boost their sex drive, increase their muscle mass and improve their memory but there have been concerns regarding the safety of use.
In January, the FDA announced that it is investigating reports of increased odds for stroke, heart and death in men that use FDA-approved testosterone products. The investigation followed the publication of two separate studies that suggested elevated cardiovascular events in men receiving testosterone treatment.
Findings of a study published in the Journal of the American Medical Association in Nov. 6, 2013 showed that men with underlying cardiovascular disease who were prescribed with testosterone therapy had 30 percent increased odds for stroke, heart attack and death. Another study published in PLOS ONE on Jan. 29 likewise found an association between testosterone therapy and increased risks of heart attack in both old and young men with existing heart disease.
The FDA, however, said that the new requirement to include blood clot risks on testosterone product labels is not related to its ongoing investigation. Testosterone treatment is also believed to contribute to sleep apnea, limit sperm production and stimulate existing prostate cancer.
