The regulator cited post-market reports of such clots for the
The FDA said that while testosterone products already carry a
warning about the risk of clots related to a condition that
sometimes occurs with testosterone treatment, the latest reports of
clots were unrelated to that condition, called polycythemia.
Polycythemia refers to an abnormal increase in the number of red
blood cells that sometimes occurs with testosterone treatment.
Testosterone products are also at the center of an FDA
investigation, which is looking at the risk of stroke, heart attack
and death in men taking these drugs.
The FDA said the new warning was not related to the ongoing
Testosterone treatments are approved for use by men who lack or have
low testosterone in conjunction with an associated medical
condition, such as a genetic failure of the testicles to produce
testosterone. Symptoms can include loss of libido, depression,
decreased muscle mass and fatigue.
[to top of second column]
Products on the market or about to be launched include AbbVie Inc's
AndroGel, Endo International Plc's Aveed and Trimel Pharmaceuticals
(Reporting by Esha Dey in Bangalore; Editing by Saumyadeb
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