News outlets across the county recentry carried reports of the Federal Drug Administration's required labeling that reads "possible increased risk of heart attack and strokes" on testosterone replacement products.
Medical consumers have been blasted by advertisements targeting patients with low testosterone or "low-T" in recent years. That's because the incidence of low testosterone is more widespread than previously recognized.
The health risks of low testosterone are well-established. On the other hand, the link between testosterone replacement and heart attack/strokes is sketchy at best. The FDA labeling requirement has overemphasized the latter without recognizing the former.
Patients with low testosterone are at increased risk of obesity, depression, osteoporosis, diabetes and hyperlipidemia. Apparently, a normal testosterone level is essential to normal health at any age. It's true that average testosterone levels do decline slightly with advancing age. Nevertheless, a truly low or abnormal testosterone is NOT a normal part of aging and DOES increase the risk of the above-mentioned diseases. In our experience, patients with low testosterone consistently report depression, fatigue, loss of concentration and loss of sexual function and/or desire. In short, their quality of life is plainly compromised by low testosterone. Testosterone replacement holds much promise for such patients.
There are some known undesirable side effects to testosterone replacement. These occur in a small percentage of patients on therapy and include an abnormally increased blood count, an elevated level of estrogen (female hormone) or depression of sperm production. These conditions are typically monitored and managed (if they occur) in patients who take testosterone replacement.
The picture becomes quite murky, however, when looking at patients who actually suffer heart attack/strokes while on testosterone. What clouds the issue is the overall poor state of health of many patients on testosterone replacement to begin with. That is, if you are 75 years old with a history of high blood pressure, diabetes and prior bypass surgery then you have an increased risk of heart attack/strokes whether you take testosterone or not. The scientific literature includes many articles that explore the pattern of heart attacks/strokes in patients on testosterone replacement. But most, if not all, of the articles do not adjust for the poor state of baseline health in testosterone therapy patients. Many of the papers actually found NO increased risk of heart attack/strokes when these "co-morbid disease" factors were considered.
Finally, think about the many healthy men who enjoy day-to-day life with a normal testosterone level WITHOUT requiring any form of replacement. If having a normal testosterone level increases the risk of heart attack/strokes, then why hasn't the FDA encouraged these men to take measures to LOWER their testosterone levels? The answer is obvious. Such measures would be absurd. In fact, it is almost as absurd to use labels warning of "possible heart attack and strokes" to frighten a man with low testosterone and possibly prevent him for receiving therapy that could very well improve his quality of life.
At the end of the day, low testosterone is an endocrine disorder. Likewise, diabetes and low thyroid are endocrine disorders. Now, can anyone imagine telling a diabetic they should avoid insulin due to possible/unproven health risks? Just like diabetes and low thyroid, there IS proven treatment for the endocrine disorder that is low testosterone. Men should be able to discuss the treatment with their doctor without having to listen to scare tactics from the FDA.
If you suffer from low testosterone or are considering testosterone replacement in the future, we invite you to discuss any possible health concerns with your provider.
Copyright (C) 2016 Steven A. Johnson, M.D., P.A.
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COMMENTARY: FDA labeling requirements for testosterone replacement overstate risks (Herald Democrat)