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Safety of Testosterone Replacement Products Called Into Question

Middle aged men and older men in the U.S. are being prescribed testosterone replacement therapy in ever increasing numbers. Low testosterone can lead to impaired sexual function, fat distribution problems, weakening bone density; and perhaps even a higher risk of heart disease. chat-1391244-m.jpg

Products like GlaxoSmithKline’s Testim; Eli Lily’s Axiron, and AbbVie’s AndroGel are three of the testosterone replacement products approved by the U.S. Food and Drug Administration. Unfortunately, manufacturers of some of these products have found themselves accused of hiding risks. AbbVie, for example, has been sued because men who used AndroGel claim they experienced unexpected side effects due to the low-T treatment. Several of the plaintiffs experienced heart attacks, while others had strokes.

With a growing number of studies showing testosterone replacement products as problematic, the Food and Drug Administration (FDA) finally announced it was going to reassess whether the testosterone therapies the agency approved are actually safe.

While this action comes too late for some of the man who have been hurt, an in-depth safety investigation could prevent more men from suffering potentially life-threatening complications. For men who have already experienced side effects, a Boston defective product lawyer could help you pursue a damage claim.

Safety of Testosterone Replacement Reconsidered

As Healthline reports, there have been multiple studies showing potentially serious problems with testosterone replacements.

  • A study in PLOS ONE found a two-fold increase in the risk of heart attack in men aged 65 and up within 90 days from the time the men begun using testosterone therapy.
  • The same PLOS ONE study identified a two-to-three fold increased risk of heart attack in men under 65 who had a history of heart disease.
  • A study of U.S. veteran’s medical records published in the Journal of the American Medical Association showed that men who had testosterone therapy at around age 60 had a 30 percent greater risk of stroke, heart attack and death compared with men who did not receive therapy for low-T.
  • A 2010 New England Journal of Medicine study had to be discontinued when the men involved began to experience cardiac problems, as well as respiratory and skin issues. The goal of this study had originally been to assess the impact of testosterone on muscle function in men over 65.

These problems would be bad enough if men knew about the drug risks and if there was evidence that the benefit of testosterone therapy could possibly outweigh the downsides. Unfortunately, it does not look like either is the case. A study in the Journal of Clinical Endocrinology & Metabolism showed that testosterone therapy likely did not have an impact on improving heart health.

If testosterone therapy has few benefits and has serious potential side effects, it is a natural question to wonder why the FDA ever approved it in the first place. Manufacturers, of course, sold the product to make money and they may not have been overly concerned with whether it was safe or effective. These manufacturers could now be made to pay for the harm the testosterone replacement products caused if the plaintiffs prevail in their claims.

If you are the victim of defective drugs in Massachusetts, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

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