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FDA Adds Heart Warning to Testosterone Products

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Jarod Cassidy3 years ago

The U.S. Food and Drug Administration (FDA) has ordered that makers of testosterone products must update their products’ labels in order to clarify their products’ approved indications and to advise on a potential risk of heart attack and stroke, according to Bloomberg.

Background to the FDA Decision

Studies conducted by the University of Texas Southwestern Medical Center at Dallas and the National Institute of Aging both found that elderly men treated with testosterone replacement products were at an increased risk of suffering hypertension, heart attack, stroke, and death.

Another study, published in PLoS One in 2014, found that men over the age of 65 and men with undiagnosed heart disease experienced a two-fold increased risk of heart attack after the first 90 days of testosterone therapy.

That same year, the FDA announced that it would be investigating the efficacy and safety of testosterone therapy.

Among the products investigated by the FDA were:

  • Axiron (Eli Lilly)
  • Androderm Patch (Actavis PLC)
  • Androgel (AbbVie)

About the Testosterone Label Update

According to the FDA, all testosterone products must carry a warning addressing an increased risk of heart attack and stroke.

Additionally, labels must now state that that testosterone replacement therapy has only been approved to treat low testosterone levels (low-T) caused by hypogonadism. Hypogonadism is the result of disorders of the testicles, pituitary gland, or brain.

In their decision, the FDA reiterated that testosterone is not indicated for the relief of low-T symptoms that are related to aging, despite a growing market for such treatment.

The FDA is also requiring manufacturers of testosterone products to conduct clinical trials analyzing the risk of heart attack and stroke associated with their individual drugs.


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