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06 Mar 2015

Drug Companies Must Change Testosterone Labels

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On Tuesday, the United States Food & Drug Administration issued a statement that mandates testosterone supplements to carry a new label warning of the risk of heart attack and stroke. The address comes as a follow up to their January 31st, 2014 update alerting the public of their investigations into testosterone replacement therapy. Testosterone, or Low-T supplements, has been prescribed to millions of men as a means to reduce the adverse effects of aging. However, mounting evidence has shown a potential link between these supplements and life threatening complications.

In its statement, the FDA reiterated that testosterone therapy has only been approved for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that can cause a condition called hypogonadism. More recently, however, physicians have begun prescribing testosterone treatments to men who have low testosterone for no reason other than the natural effects of aging. In their address, the FDA clarifies that testosterone therapy has not been approved for this purpose.

In recent years, extensive marketing campaigns have been launched promoting the use of testosterone supplements as a means to combat low energy and sex drive, as well as a way to produce lean muscle mass. Many men, however, have suffered from serious conditions resulting from taking these drugs. Some of the potential side-effects of testosterone supplements include:

  • Heart attack
  • Stroke
  • Deep vein thrombosis (DVT)
  • Pulmonary embolism
  • Blocked arteries
  • Blood clots

In addition to the mandated label changes, the FDA is also requiring manufacturers of approved testosterone drugs to conduct extensive clinical trials to more clearly identify potential complications. They also encourage manufacturers to work together on these trials, but will allow separate testing.

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