Consumer News

FDA Reins In Labeling of ‘Low T’ Drugs

Agency calls on drugmakers to add certain health risks to label.

Consumer News

FDA Reins In Labeling of ‘Low T’ Drugs

Noting a potentially dangerous trend in the overprescribing of testosterone products to men whose symptoms are merely the result of normal aging, the FDA this week moved to rein in the marketing of such low testosterone or “Low T” treatments.

“Aging men can […] experience signs and symptoms such as decreases in energy level and problems with sexual function, but it is uncertain whether these are caused by the lowered testosterone levels or due to normal aging,” the agency said Tuesday. The FDA warned that prescription testosterone products have not been proven safe or effective for treating common signs of aging.

Screen Shot 2015-03-05 at 2.46.22 PM
A screenshot from an AndroGel commercial.

Marketers of testosterone products pitch their drugs to men troubled by a decreased sex drive, moodiness or low energy, urging them to talk to their doctor about Low T.

But even for men whose medical condition is approved for a testosterone prescription through a diagnosis of disease or injury, the FDA warns that there are potential health risks, including a possible increased risk of heart attack and stroke.

Now, in addition to calling on drugmakers to change their labeling to clarify the approved uses of their medications, the FDA wants these risks added to the label and a clinical trial looking into the potential side effects on the part of the drugmaker.

A spokesperson for Endo Pharmaceuticals, which makes several testosterone products including Testim, said in an email to that the company will work with the FDA to ensure that its drugs are “prescribed to the appropriate patient population, as deemed by the [a]gency.” also reached out to AbbVie, which makes AndroGel, but has not yet heard back from the company.

The use of testosterone products has skyrocketed in recent years, from 1.3 million patients receiving a prescription in 2009 to 2.3 million in 2013, according to the FDA. The popularity of these products — which come in gels, patches and injections, among other formulations — has generated sales topping $2 billion.

But the surge in prescriptions has also led to an onslaught of lawsuits, some of which claim that the drugs do not adequately disclose the risks associated with taking them.

For more of our coverage on low testosterone products, click here.

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