Manufacturers of FDA-approved testosterone replacement products promise that they can help restore sexual desire and help eliminate excess body fat, fatigue and depression.  It’s no wonder testosterone prescriptions have tripled since 2001.

But recent studies question the safety of the products and point to an increased risk of heart attack and stroke for men taking testosterone – particularly if they are over 65 or already have a heart condition.  Many doctors are writing testosterone prescriptions without checking to see if their patients have low testosterone levels.

The FDA Is Investigating Testosterone Drug Safety

The Food and Drug Administration announced recently that it was investigating whether FDA-approved testosterone drugs are linked to an increased risk of heart attack, stroke and death.  The investigation was sparked by a pair of recent studies that each suggested an increased risk.

One of the studies found that men being treated with testosterone were 35 percent more likely to have a heart attack in the first 90 days after starting testosterone therapy.  Men over 65 saw their heart attack risk increase twofold.  Men under 65 with a prior heart condition also had a twofold increase in heart attack risk.

The second study, an observational analysis of Veterans’ Affairs patients published in the Journal of the American Medical Association in November 2013, found that patients treated with testosterone therapy had an increased risk of death, heart attack or stroke.  The study suggested a 30 percent increased risk of heart attack or stroke.

The FDA has approved testosterone therapies for men who have low testosterone coupled with another medical condition such as a failure to produce testosterone because of a genetic condition or the effects of chemotherapy.  Testosterone supplements are not approved for men without these associated medical conditions.

Consumer Group Calls For Warnings on Testosterone Products

The consumer advocacy group Public Citizen believes the FDA should take additional steps.  It has petitioned the FDA to immediately require testosterone products to carry “black box” warnings about the increased risk of suffering a heart attack or other cardiovascular event.

According to the petition, there were more than 5 million testosterone prescriptions filled in the U.S. in 2013 – 400,000 of them in December alone.  More than 90 percent of these were for the common testosterone drugs Androgel, Axiron, Testim and Fortesta.  Currently, testosterone products do not have to mention cardiovascular risk on their labels.

Public Citizen said its petition was prompted by growing evidence of the risk of heart attacks and other cardiovascular events in patients being treated with testosterone.  This evidence comes from individual randomized studies conducted since 2010, a recent overall analysis of 27 studies going back 20 years, and the studies that the FDA relied on to launch its investigation.

Public Citizen’s petition said that “the hyped-up nature of the ‘low-T’ advertising campaigns ensures that many U.S. men who are taking the products do not meet the FDA-specified criteria of both low testosterone levels and an associated medical condition due to hypogonadism. Evidence of the success of these campaigns can be seen in the recent finding that almost 25% of men prescribed testosterone in this country had not previously even had a blood test to determine if their testosterone level was low.”



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