FDA Warns of Overprescribed ‘Low-T’ Testosterone Therapy

In recent years, American television watchers have been inundated with ads for testosterone replacement drugs to treat a condition they’ve named “Low-T,” leading us to wonder if more men really are suffering from conditions like hypogonadism, or if it’s just become a fad or a way for men to push back against the inevitable effects of aging.

Testosterone therapy can be beneficial in multiple ways, from increased sexual drive and performance to improved memory, focus and concentration, so many men seek testosterone therapy when they begin experiencing symptoms of “Low-T” that include low sexual drive, loss of muscle and increase in body fat, and decreased motivation or sense of well-being.

Testosterone is an extremely influential hormone in the male body, similar in some ways to estrogen’s importance in the female body. And just like women, men essentially go through a sort of menopause, referred to as “andropause” or “male menopause.” The problem seems to be that the market is flooded with drugs promising relief from “Low-T” but whose side effects far outweigh the benefits if the problem is a natural result of aging.

Bloomsberg Businessweek reports that a hearing of an advisory panel to the FDA this past September voted 20 to 1 to “revise labels on test drugs such as AbbVie’s AndroGel and Lilly’s Axiron to make it clear the products should be prescribed only to men with serious testosterone deficiencies,” and not to average men who are experiencing normal hormonal decline that all men experience.

The statistics illustrate the Low-T craze with FDA data reporting that 2.3 million people were given prescriptions for testosterone in 2013, up from 1.3 million in 2010. Yet, according to Bloomberg Businessweek, “only half of those men were diagnosed with the testosterone-depleting condition Hypogonadism.” And because of these abuses, lawsuits are actually being filed on “behalf of men who allegedly suffered serious heart problems due to their use of AndroGel and similar medications,” reports a press release by Bernstein Liebhard LLP. This release also notes that new reports have found additional safety concerns.

In all, more than 220 testosterone treatment lawsuits have been filed in U.S. District Courts attacking manufacturers of these testosterone therapies for, according to the same press release, “aggressive marketing that encouraged men without any real medical need to seek treatment for low sex drive, fatigue, and other symptoms merely associated with aging.”

But is it fair to attack these companies for doing what so many other drug companies are also guilty of doing on a daily basis? Just consider estrogen replacement therapy (ERT) for women who are experiencing menopausal symptoms and want relief. From pills to patches, ERT is very popular among women; however, despite equally fearsome side effects like blood clots, ERT seems to get less criticism than testosterone replacement therapy. While the FDA works to revise its standings on these drugs, it is helpful to keep in mind that testosterone replacement therapy should only be sought if a real problem or diagnosis exists, so proceed with caution.