FDA Evaluating Safety of Testosterone Products

The FDA has announced that it will be evaluating the safety of agency-approved testosterone products after two studies linked the popular “low-T” treatments to an increased risk of heart attack, stroke and death. The agency has only approved these products for use in men “who lack or have low testosterone levels in conjunction with an associated medical condition”; however, concerns have been raised that the gels, patches, pellets and injections are being overprescribed to men who do not meet the criteria for use, unnecessarily putting some men at risk for serious side effects.

The FDA expressed that it has not concluded that testosterone therapy increases the risk of cardiac problems and urged patients to speak to their doctors before stopping use. When the agency has finished reviewing the recent studies and other available data, it will announce its final conclusions and recommendations regarding the use of FDA-approved testosterone products.

Before making its announcement, the FDA reviewed the results of two studies, the first of which was published in the Journal of the American Medical Association (JAMA) in November

This study found that nearly 30 percent of men using testosterone products demonstrated an increased risk of heart attack, ischemic stroke or death when compared to those who were not receiving testosterone therapy. The most recent study reviewed by the agency found that in a group of 56,000 men, patients over the age of 65 and middle-aged men with a history or heart disease had twice the rate of heart attacks in the first 90 days after starting testosterone therapy.

The FDA is urging doctors and patients to report side effects related to use of these products through MedWatch.