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The FDA has released a new warning about testosterone replacement drugs.

It was back in January 2014 that they announced they were investigating the risk of stroke, heart attack, and death in men taking testosterone products like AndroGel, Testim, and Fortesta. They reiterated at the time that they had approved testosterone drugs only for men suffering from low testosterone levels caused by a medical condition—not for addressing common symptoms of aging, such as muscle loss and fatigue.

Now, the administration has approved class-wide labeling changes for all prescription testosterone products, adding a new warning and updating the abuse and dependence section. The new verbiage warns about the potential risks associated with abuse and dependence of testosterone drugs.

FDA Warns of Abuse Potential with Testosterone Therapy Drugs

These new warnings will be placed on all testosterone replacement therapy medications, including AndroGel, Testim, Axiron, Depo-Testosterone, Fortesta and others. In general, they are meant to alert doctors and patients to the fact that these drugs can lead to addiction and abuse.

Testosterone was classified as a controlled substance in the 1990 Anabolic Steroids Control Act. It was noted then that testosterone, usually at higher doses than those typically prescribed, could be abused by adults and adolescents, including body builders and other athletes. Side effects can include heart attack, heart failure, stroke, depression, hostility, liver toxicity and male infertility.

The new warning approved by the FDA warns prescribers that users may abuse the drugs and about the serious outcomes that may result. The administration reminds users that prescription testosterone therapy is FDA-approved only for men “who have low testosterone due to certain medical conditions.” These conditions may be caused by genetic problems, damage to the testicles, infection or chemotherapy.

Why Is the FDA Warning About Addiction Now?

Why would the FDA wait until now to add these warnings onto these drugs?

Most believe it is because of the rising use of these products. Manufacturers aggressively advertised testosterone replacement drugs as providing solutions for age-related symptoms, essentially “creating a disease” according to some reports and encouraging men with fatigue and muscle loss to ask their doctors about “low-T.”

The FDA states that between 2009 and 2013, the number of men prescribed testosterone jumped more than 75 percent.

Health professionals watched with concern as more and more men started taking the drugs without going through the appropriate tests. In a 2014 study published in the Journal of Clinical Endocrinology & Metabolism, researchers found that 40.2 percent of men did not have a testosterone test in the 180 days before beginning therapy, and 50 percent had only one test. (Doctors typically recommend more than one test to get a more accurate view of the actual testosterone levels.)

Reuters reported that the new FDA warning is “the latest in a series of actions the agency has taken to try to curb prescriptions of a product whose use has soared over the past decade, especially among middle-aged men.”

In April 2015, the FDA required another label change on these drugs, urging manufacturers to clarify the approved uses of the medications, and to add information about the possible increased risk of heart attacks and strokes in patients taking them.




One Comment

  1. Gravatar for Roco

    After 8 years on Androgel, I stopped and went into debilitating Testosterone Withdrawal Syndrome. No prescriber EVER told me this downside. Symptoms:

    weakness, depression, hot flashes, night sweats. Terrible. Research says I may have to stay on it the rest of my order to avoid these horrible symptoms. Bottom line: I cannot find a doctor/specialist in my metropolitan area who knows the protocol for going off TRT. If you're looking to go on TRT, ask your prescriber about how to get off. Chances are, they won't know.

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