FDA Testosterone Warning “Premature” – Evidence Continues to Mount
Two major medical conferences in the last week (The Endocrine Society & American College of Cardiology) have presented a total of four new papers showing no increased cardiovascular risk for men using testosterone therapy. (1, 2)
The first study presented at the American College of Cardiology included 7245 men in 15 hospitals and 150 clinics. The second was a meta-study of 29 separate studies including 122,000 men.
“When we pulled out all the studies so far, testosterone in any form—whether it was a gel, an injection, or older pills—did not increase the risk of cardiovascular events, such as heart attack, sudden cardiac death, stroke, or hospitalization for heart failure,” said Dr Pawan Patel (Regions Hospital, St Paul, MN), lead investigator of the meta-analysis.
The Endocrine Society conference highlighted two additional studies; showing no additional ‘venous thrombotic events’ (blood clots) in one, and no increase in ‘major adverse cardiovascular events’ in the other.
“This has become a popularized and controversial issue,” Ronald Swerdloff, MD, from the University of California, Los Angeles, told Medscape Medical News at the ENDO 2015 meeting.
“The regulatory agencies have raised questions based upon some studies that suggest there may be adverse effects. But many other studies suggest there are no adverse effects, and there are mainly epidemiologic studies showing there may be adverse effects of low testosterone.”
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