February 3rd, 2014

FDA Evaluating Safety Of Testosterone Products

The FDA has announced that it is evaluating the cardiovascular safety of testosterone products. The investigation is prompted by two recent published studies that found a significant increase in cardiovascular events in men who received testosterone therapy.

The FDA said it had not concluded that testosterone is unsafe but recommended that “health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.” Testosterone is approved for use only in men who lack or have low testosterone levels in conjunction with an associated medical condition.

The first study, published in JAMA last November, followed 8,709 male veterans with low testosterone levels undergoing coronary angiography. After adjusting for baseline differences, the group of men who went on to start testosterone therapy after their angiogram had a 29% increase in risk for death, MI, or stroke.

The second study, published earlier this week in PLoS ONE, followed 55,593 men and compared the MI rate in the year before their first prescription for testosterone therapy with the rate in the 90 days after filling that prescription. For men 65 years and older the start of testosterone therapy was associated with a two-fold increase in the risk of MI. For men under 65 years with a history of heart disease there was a two- to three-fold increase in risk. However, there was no increase in risk for men under 65 with no history of heart disease.


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