FDA Reviewing Low-T Therapy After Second Study Shows CV Issues

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WASHINGTON — With a second study showing increased risk of cardiovascular events among men using testosterone replacement therapy, the Food and Drug Administration announced that it is reassessing the safety of those products.

The agency said it is investigating the risk of stroke, heart attack and death in men taking FDA-approved products for low testosterone.

“We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy,” the agency reported in a safety alert.

In January, a study appearing in PLOS ONE, an online open access journal, found that the risk of myocardial infarction following initiation of testosterone therapy is substantially increased in older men and in younger men with pre-existing diagnosed heart disease.

A VA study late last year also found that testosterone replacement therapy increased risks of death, heart attack or ischemic stroke in veterans who had undergone coronary angiography and low serum testosterone levels.

The FDA said it will continue to evaluate information from the studies and other available data and then communicate final conclusions and recommendations.

Until then, it said, patients should not stop taking prescribed testosterone products without discussing the issue with healthcare professionals, but clinicians should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.

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