On 2015 Jul 04, David Keller commented:

A large, well-designed controlled study is needed to settle this debate

Dr. Morgentaler argues persuasively in favor of the safety and benefits of prescribing testosterone therapy for widened indications, especially in aging men. The FDA warning on testosterone therapy, however, states: "The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone" based on "a possible increased risk of heart attacks and strokes in patients taking testosterone." (1)

We have seen prior cases where faint signals of cardiovascular harm were later verified in larger studies, and led to the withdrawal or restriction of drugs (e.g. Vioxx, Avandia, PremPro). My primary duty to my patients is to do no harm. We need a large, well-designed, controlled study of testosterone therapy to prove its safety and benefits for each proposed indication for which it is not currently approved. Until such proof is available, we should not widen our prescribing practices for this powerful steroid sex hormone, which has so many pleiotropic effects.

Reference:

1: FDA Drug Safety website, accessed on 7/4/2015, http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm

On 2015 Jul 04, David Keller commented:

A large, well-designed controlled study is needed to settle this debate

Dr. Morgentaler argues persuasively in favor of the safety and benefits of prescribing testosterone therapy for widened indications, especially in aging men. The FDA warning on testosterone therapy, however, states: "The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone" based on "a possible increased risk of heart attacks and strokes in patients taking testosterone." (1)

We have seen prior cases where faint signals of cardiovascular harm were later verified in larger studies, and led to the withdrawal or restriction of drugs (e.g. Vioxx, Avandia, PremPro). My primary duty to my patients is to do no harm. We need a large, well-designed, controlled study of testosterone therapy to prove its safety and benefits for each proposed indication for which it is not currently approved. Until such proof is available, we should not widen our prescribing practices for this powerful steroid sex hormone, which has so many pleiotropic effects.

Reference:

1: FDA Drug Safety website, accessed on 7/4/2015, http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm