The U.S. Food and Drug Administration said all testosterone products on the market should include in their labels a general warning about the risk of blood clots in veins. The regulator cited post-market reports of such clots for the warning.
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.
In January, the FDA said it has been monitoring the stroke and heart risks posed by testosterone products but in light of two recent studies has "decided to reassess this safety issue," prompting an investigation.
Testosterone is a hormone essential to the development of male growth and
masculine characteristics. Testosterone products are FDA-approved
only
for use in men who lack or have low testosterone levels in conjunction with an
associated medical condition. Examples of these conditions include failure of
the testicles to produce testosterone because of reasons such as genetic
problems or chemotherapy. Other examples include problems with brain structures,
called the hypothalamus and pituitary, that control the production of
testosterone by the testicles.
None of the FDA-approved testosterone products are approved for use in men
with low testosterone levels who lack an associated medical condition.
FDA-approved testosterone formulations include the topical gel, transdermal
patch, buccal system (applied to upper gum or inner cheek), and injection.
