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US Food & Drug Administration Investigating The Safety of Testosterone-Boosting Products

 

It’s an issue where the buzzwords are flying everywhere, from “manopause” to “the He Hormone”, and the ads are everywhere, especially in men’s sports programming, touting the benefits of “Low-T” testosterone therapy to help rev-up men who are feeling tired and “not up to snuff” sexually. But what may send some men to the pharmacy may subsequently send others to the OR after a pair of recent studies show the dangers of taking the hormone may be more serious than previously thought.

 

A new study published in the Public Library of Science journal PLOS ONE confirms and builds upon previous research published in November in the Journal of the American Medical Association. And it’s all in the numbers.

 

In the United States, almost 3% of men aged 40 and older have been prescribed testosterone replacement therapy – a market Bloomberg Businessweek estimates could top $5 billion by 2017. The AMA published study at the University of Texas at Southwestern Medical Center in Dallas checked angiogram records for over 87 hundred men diagnosed with low testosterone levels between 2005 and 2011. They found a 30% increased risk of heart attack, stroke or death in the more than 12 hundred men who got Low-T therapy.

 

The more recent study at UCLA looked at the insurance records of more than 55 thousand men and the numbers were even more ominous:

 

Heart Attack Risk in the 90 Days After Low-T Treatment

 

Men 65 and older:  More than double.

 

Men 75 and older: More than triple.

 

Men under 65 with a history of heart disease:  More than triple.

 

The study also compared men getting Low-T therapy with those getting treatment with erectile dysfunction drugs such as Viagra and Cialis but found only a slightly raised risk of heart attach from the ED drugs.

 

All this has prompted the FDA to say it will reassess the safety issues of Low-T therapy, but also issued the following ‘moderating message: “At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. 

 

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,”

 

We’ll follow the FDA reassessment and report any updates.

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