FDA Cautions on Low Testosterone Treatment Side Effects
After Studies Show Low Testosterone Treatment Side Effects Including an Increase of Cardiovascular Risks, the U.S. Food and Drug Administration (FDA) has Released a Safety Announcement Stating They Are Investigating the Safety of Low-T Drugs.
Until the recent FDA announcement, consumers may not have been aware of low testosterone treatment side effects. However, a study recently published in the Journal of the American Medical Association showed a 29 percent increase in the risks of stroke, heart attacked, and even death in men who were generally over the age of 60 and had heart disease. (http://jama.jamanetwork.com/article.aspx?articleid=1764051)
Along with the JAMA study, a second major study published in PLoS ONE found men aged 65 and over who utilized low testosterone treatment for three months or more doubled their risk of heart attack. Younger men with heart disease also showed an increased risk of cardiovascular events at three months of use. (http://www.nytimes.com/2014/02/04/opinion/dont-ask-your-doctor-about-low-t.html?_r=0)
According to Cleveland Clinic Cardiologist Dr. Steve Nissen, the need for wide spread use of testosterone therapy and its health risks merit further study. “Just like women go through menopause, men go through man-opause. That’s probably a normal part of male aging, and treating it as a disease may get us in a lot of trouble,” CBS News reports. (http://www.cbsnews.com/news/testosterone-replacement-therapy-can-carry-health-risks/)
The FDA said in its statement that it continues to evaluate the study data and that it will publish its “final conclusions and recommendations when the evaluation is complete.” (http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery)
Millions of men suffer from low testosterone levels and according to the New York Times, treatments for low-T have become a $2 billion a year industry that projected to continue to grow. In fact, testosterone was approved by the FDA in 1953, it’s been in the last ten years or so that prescriptions for the drug have skyrocketed. The Times reports that AndroGel, a leader in the testosterone market, was prescribed about three million times in 2012 alone. (http://www.nytimes.com/2014/02/04/opinion/dont-ask-your-doctor-about-low-t.html?_r=0)
Low testosterone levels can cause fatigue and decreased libido, as well as muscle and bone loss, and is a normal part of aging, especially for men who are obese. However, it has become heavily marketed directly to consumers as a way to feel better and this has some medical professionals concerned.
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