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Low “T” or high risk?

Mar 11, 2015 02:00PM ● By Cate Reynolds
The FDA continues looking out for us by issuing a warning concerning the use of testosterone products and directing manufacturers of prescription testosterone products to revise their labels to warn about the risk of heart attack and stroke. The concern is that men without a valid medical need are taking this medicine.

The FDA points out that testosterone is a hormone essential to the development of male growth and masculine characteristics. FDA-approved products are 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 (the hypothalamus and pituitary) that control 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 formulations include topical gel, transdermal patches, applications to upper gums or inner cheek, and injections.

Additionally, the manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, were required to include a boxed warning on the products' labels. The Agency required this action after receiving reports of adverse effects in children who were inadvertently exposed through contact with a person being treated with these products.

--Sarah Hagerty
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