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FDA Panel Votes to Impose Strict Limitations on Testosterone Drugs

October 8, 2014  ·  By HM&M



Testosterone therapy drugs are prescribed to men who suffer from “low-T” or low testosterone, a condition that can lead to a decrease in bone and muscle mass, loss of libido, and depression. Since the early 2000s, the use of testosterone therapy has quadrupled for men in their 40s. In the United States, testosterone therapy has risen to a $2 billion industry.

In 2013, The New York Times published an article that reportedmarketing for testosterone therapy targeted men with common aging symptoms, such as lack of energy, rather than those tested for hypogonadism or “low-T.” Research has questioned whether men who are prescribed testosterone drugs all suffer from the “low-T” condition and if the benefits of testosterone outweighs the risks.

Previous research from the Journal of the American Medical Associationshowed that testosterone therapy is linked to a 30 percent increase of risk of stroke or other cardiac condition. Several months following this study,PLOS One published a study reporting that testosterone drugs double the risk of heart attack in men over 65 and triple the risk in younger men with heart disease.

The New York Times recently reported that an expert panel for the FDA voted almost unanimously to implement new limitations on the testosterone drug industry. Among the recommendations: stricter labels for medications. Dr. Michael Domanski, a member of the panel and director of heart failure research at Mount Sinai School of Medicine, said, “The whole idea is to try to rein in the inappropriate advertising and use of these drugs.”

If the FDA follows the panel's recommendations, it could mean a significant decrease in the number of men prescribed testosterone therapy and possibly limit insurance coverage for its use. Evidence presented to the panel revealed that a fifth to a quarter of men prescribed testosterone drugs have not received a baseline test of their testosterone level.

As of last year, 2.3 million Americans were being treated with testosterone drugs. If you have taken testosterone therapy and need legal counseling in Illinois, contact an experienced Chicago medical malpractice attorney today.

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