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 Prescriptions for low testosterone, or "Low T" have soared over the
past decade, driven by a surge in use by men facing falling
testosterone levels as they age.
The number of men being prescribed testosterone jumped more than 75
percent, to 2.3 million, between 2009 and 2013. About 70 percent of
these patients were between the ages of 40 and 64, the FDA said.
Tuesday's ruling restricts companies from marketing or promoting
their products for age-related low testosterone.
The agency's announcement takes on board most of the recommendations
of an independent advisory panel, which voted in September to
endorse restricting the use of these treatments to men with medical
conditions, such as genetic disorders or tumors, that impair
testicular function.
The FDA has also asked manufacturers of approved products, including
skin patches, solutions, intramuscular injections and topical gels,
to conduct studies to determine whether the treatments raise
cardiovascular risk.
Last year, the Canadian health regulator issued a similar warning of
possible serious and life-threatening cardiovascular problems
associated with these therapies.
AbbVie Inc's AndroGel, one of the most widely-used products, raked
in sales of $934 million in 2014. Other products include Endo
International Plc's Testim and Eli Lilly & Co's Axiron.
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A number of drugmakers, including Antares Pharma Inc, Repros
Therapeutics Inc and Lipocine Inc, are currently developing their
own low T treatments.
Last year, the agency mandated that manufacturers must include a
warning about the risk of blood clots in the veins on their product
labels.
Symptoms of low testosterone include loss of libido, decreased
muscle mass, fatigue and depression.
(Reporting by Natalie Grover in Bengaluru; Editing by Simon
Jennings)
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