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FDA to Discuss Testosterone Therapy

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Hopeanne Wohlers3 years ago

The U.S. Food and Drug Administration (FDA) will be conducting a joint meeting to address the benefits and risks presented by testosterone replacement therapy.

FDA Schedules Testosterone Discussions

According to Reuters, the FDA has announced plans to discuss the adverse cardiovascular effects of testosterone replacement therapy at an advisory committee meeting on September 17th.

To do this, the FDA will conduct a joint meeting with the bone, reproductive, and urologic drugs committee and the drug safety and risk management advisory committee.

As of June, the FDA has required that all testosterone products contain a general warning message about the risk of blood clots in veins on their label.

Some of the products on the market are: AbbVie Inc's AndroGel, Endo International Plc's Aveed and Trimel Pharmaceuticals Corp's Natesto. All of the aforementioned products require warning labels about the cardiovascular risks associated with the testosterone replacement therapy drugs.

About Testosterone Replacement Therapy

Information provided by the Cleveland Clinic:

  • Testosterone replacement therapy is used by adult males with low levels of testosterone.
  • Symptoms of testosterone deficiency are: decreased sex drive, decreased sense of well-being, depressed mood, difficulties with concentration and memory, erectile dysfunction.
  • Changes that occur with testosterone deficiency are: a decrease in muscle mass, with an increase in body fat, variable effects on cholesterol metabolism, a decrease in hemoglobin and possibly mild anemia, fragile bones (osteoporosis), a decrease in body hair.

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