Possible Restrictions for Testosterone Therapy

Eileen Bailey Health Guide
  • An expert advisory panel for the U.S. Food and Drug Administration (FDA) recently recommended that testosterone medications be restricted to men who have low testosterone levels due to injury or illness. Their recommendations included tightening labels on the medications to restrict its use and to study possible increased risk of heart attack and stroke from using this medication.


    Testosterone replacement therapy is meant to help men who have low testosterone because of illness, injury or chemotherapy. According to the FDA it is approved for “men who lack or have low testosterone levels in conjunction with an associated medical condition.” In recent years, however, it has been touted as a drug that can help with weight loss, improved sexual desire and performance and increased energy. Since the early 2000s, the use of testosterone has quadrupled for men in their 40s. In 2013, more than 2 million men in the Americas were taking testosterone. [1]

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    Men begin losing about 1 percent of testosterone per year after the age of 40. This is part of the normal aging process and, according to some experts, doesn’t need to be treated. While there is a cut-off point where you are considered to have low testosterone (under 250 nanograms per deciliter), the range of normal testosterone is large - from 250 to 1,100 nanograms per deciliter, making it difficult for doctors, especially if levels are between 250 and 300 nanograms per deciliter. Many believe that men are simply trying to reverse the normal aging process and don’t need to take testosterone therapy.


    Pharmaceutical companies have, at least in part, driven the high use of testosterone for “Low T,” causing testosterone therapy to become a multibillion dollar industry. Experts fear that men are treating normal aging symptoms, not illnesses, and this may carry health risks and side-effects. In January, 2014, the FDA initiated a study of the risks of heart attack and stroke from testosterone therapy. A previous study showed a 30 percent increase risk of death, heart attack or stroke, however, the advisory panel indicated past studies have been inconclusive. In June, 2014, the FDA began requiring manufacturers to include a warning about the risk of blood clots. In July,2014 Canada issued warnings about testosterone treatments, stating they can increase the risk of heart attack, stroke, blood clots and  irregular heart rates.


    The new labeling restrictions have been recommended by an advisory panel. Although the FDA is not required to follow the recommendations, they normally do follow advice from these types of panels. The restrictions would limit the advertising allowed, manufacturers would need to market only to those affected by illness, not the aging process. Doctors, however, would still be able to prescribe the treatment “off-label” which means it is prescribed even though not approved by the FDA for the particular condition.


    References:


    [1] “F.D.A. Panel Backs Limits on Testosterone Drugs,” 2014, Sept 17, Sabrina Tavernise, The New York Times


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    “FDA Panel Recommends More Study on Testosterone Drug Use,” 2014, Sept 17, Wall Street Journal


Published On: September 23, 2014