- Sep 17, 2003
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FDA Panel Looks To Limit Testosterone Drug Use
The FDA has ruled that there is a lack of evidence to prove that testosterone replacement therapy is effective in treating reduced testosterone levels in aging men. The agency says that use must be more strictly regulated, while ordering further tests on the risk of heart attack and stroke.
Over the summer, the FDA required testosterone replacement therapy makers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins.
In recent years, testosterone replacement therapy treatments have shifted from doctor administered injections to at-home use gels. Androgel was approved by the FDA in 2001, followed by Testim in 2002. Axiron was approved in 2010.
In 2013, 2.3 million men got a prescription for testosterone, up from 1.3 million in 2010, according to the FDA. The agency found that roughly 50 percent of men taking testosterone therapy have been diagnosed with hypogonadism, the specific medical diagnosis for testosterone deficiency.
The FDA has ruled that there is a lack of evidence to prove that testosterone replacement therapy is effective in treating reduced testosterone levels in aging men. The agency says that use must be more strictly regulated, while ordering further tests on the risk of heart attack and stroke.
Over the summer, the FDA required testosterone replacement therapy makers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins.
In recent years, testosterone replacement therapy treatments have shifted from doctor administered injections to at-home use gels. Androgel was approved by the FDA in 2001, followed by Testim in 2002. Axiron was approved in 2010.
In 2013, 2.3 million men got a prescription for testosterone, up from 1.3 million in 2010, according to the FDA. The agency found that roughly 50 percent of men taking testosterone therapy have been diagnosed with hypogonadism, the specific medical diagnosis for testosterone deficiency.
