FDA: No Proof Testosterone Treatment Counters Male Aging

Published on August 20, 2015 by Sandy Liebhard

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Federal drug safety officials have taken to the pages of the New England Journal of Medicine (NEJM) to reiterate that age-related benefits purportedly associated with prescription testosterone treatments have yet to be proven. In fact, drugs like AndroGel, Testim and Axiron have never been approved for this indication, even though they are regularly prescribed to counter the normal male aging process.

“The benefits and risks of testosterone therapy have not been established for the treatment of men who have low testosterone levels due to aging, even if there are symptoms that seem related to the low testosterone,” Dr. Christine Nguyen, the U.S. Food & Drug Administration’s (FDA) deputy director of safety wrote in the August 20th issue of the journal.

The publication of the FDA’s report comes as thousands of men pursue testosterone lawsuits after allegedly suffering heart attacks, strokes and other cardiovascular problems related to the use of AndroGel and similar medications. Plaintiffs involved in the litigation also accuse the drugs’ manufacturers of wrongly marketing their low-T products as a remedy for fatigue, low libido and other off-label age-related issues.

Use of Testosterone Treatment Surged

Prescription testosterone therapy is only approved to treat men who suffer from hypogonadism (low testosterone) related to an underlying medical issue. However, the FDA report noted that the number of U.S. men on testosterone shot up from 1.3 million to 2.3 million between 2009 and 2013. In most cases, these patients had received a vague diagnosis of “testicular hypofunction, not elsewhere classified.” What’s more, the FDA found that the majority of men prescribed testosterone treatments haven’t even been tested for low hormone levels.

There are also safety concerns surrounding the medications. In January 2014, the FDA launched a review of prescription low-T therapy after studies linked the drugs to an increased risk of heart attacks and strokes in certain men. In March, the FDA ordered the manufacturers of AndroGel and similar medications to add new information to their labels regarding a potential association with these complications.

Low-T Litigation

Since the FDA announced its safety review, more than 2,000 men have filed lawsuits over alleged testosterone heart attacks, strokes and other cardiovascular problems purportedly related to their use. The majority of these claims are pending in a multidistrict litigation underway in Illinois federal court. The litigation’s first trials, which will involve AngroGel lawsuits, are expected to get underway next year.

Men who allegedly experienced life-threatening cardiovascular events due to their use of low-T therapy can still join this litigation. To learn more about filing a testosterone lawsuit, please call .