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article imageFDA queries testosterone supplement benefits

By Tim Sandle     Sep 10, 2014 in Health
A new report suggests that there is little much evidence to support the health benefits of testosterone-enhancing drugs. At the same time there do not appear to be any major risks linked to the use of such supplements.
This is the conclusion of a report issued by the U.S. Food and Drug Administration (FDA). Here, the FDA states that "the need to replace testosterone in these older men remains debatable." In the U.S., in 2010, 1.3 million men had received testosterone prescriptions. By 2013, that number had increased to 2.3 million.
Taken in the form of gels, pills or patches, testosterone drugs are used by millions of male patients worldwide. The argument for taking supplements is that low testosterone levels can result in fatigue, cause weight increases and suppress libido (conditions sometimes collectively called “Low-T”). The manufacturers of such products argue that by taking supplements these issues can be addressed.
Furthermore, FDA considers the idea of otherwise-healthy males using these drugs "controversial", with "...no reliable data on the benefit in such a population." There are also concerns, Pharmaceutical International reports, with older men taking supplements. One study, reported on by Fox News, indicates that older men using testosterone products are 30 per cent more at risk of experiencing a heart attack or a stroke. In addition, testosterone-enhancers taken by men aged 65-plus with pre-existing heart issues, compounds the risk further.
The concern here is that when the FDA first approved testosterone drugs for the market, this was with the expectation that they would be used only in men who suffered from low testosterone levels due to hypogonadism (the result of known testicular disease or injury). However, there is now a tendency for men to be prescribed testosterone boosters like AndroGel and Testim for what the FDA calls “age-related hypogonadism”, where testosterone levels drop due to the natural effects of getting older.
The FDA has convened an experts panel to consider whether testosterone-enhancing drugs should be more selectively prescribed. The panel is the FDA Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
The FDA has raised a big money question. 12 News notes that the market for low-testosterone, or Low-T, therapy is projected to reach $5 billion by 2017.
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