FDA Panel Recommends Label Change for Low T Usage

This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.

There could be major changes ahead in the prescribing recommendations for drugs that treat low testosterone.

A blue-ribbon expert panel voted overwhelmingly on Wednesday for the Food and Drug Administration to impose strict new limitations on the multibillion-dollar testosterone drug industry, recommending that the agency tightens labels for the medicines so they are not prescribed to men who only have problems related to aging, such as low energy and libido. The F.D.A. often takes the advice of such panels.

Once used only to treat serious medical conditions, testosterone drugs are now taken by over two million American men, mostly for symptoms that are largely a result of aging, a pattern that has alarmed some medical experts. If the F.D.A. adopts the panel’s recommendations, it could sharply reduce the number of men prescribed the medicines and clamp down on the marketing of them by drug companies. It could also limit coverage from insurance companies for their use, experts said.

One factor driving treatment is a larger number of easy-to-use testosterone drugs like gels.

Testosterone usage has quadrupled since the early 2000s for men in their 40s, driven in part by marketing that suggests the drugs are a solution for low energy, low libido and other ills, many of them associated with aging. By 2011, nearly one in 25 men in their 60s were taking testosterone. In 2013, 2.3 million Americans were being treated with testosterone therapy, according to material distributed at the panel meeting.

Many experts began raising alarms, saying that the benefits and longer-term risks of the drugs were unknown.

This year, the F.D.A. said it was reassessing the safety of testosterone products in light of recent studies and would investigate rates of stroke, heart attack and death in men using the drugs.

One of the stickiest problems had been the vagueness of testosterone drug labels, which many doctors have interpreted to include any man with low testosterone. Panelists said the label should be limited to men with serious medical conditions, such as pituitary gland problems. It was not clear what share of men that represented, though officials said it was a small minority of users. The panel was also asked to sift through the evidence for safety risks. It concluded that the evidence for risks of heart problems was mixed, and all but one of its members voted to require clinical trials for safety for at least some types of testosterone therapy.

A 2010 clinical trial found an elevated risk of heart attacks and strokes among men who took testosterone, and it was stopped early as a result. Other trials have found no increased risk.

The panel heard surprising facts: A fifth to a quarter of men who are prescribed testosterone have not had a baseline test of their testosterone level. And 60 percent of the prescribing is done by primary care doctors, while just 20 percent of the drugs are prescribed by specialists like endocrinologists and urologists.

If you or a loved one was prescribed a testosterone supplement and suffered a cardiac or clotting event, please contact The Michael Brady Lynch Firm for a no cost, no-obligation evaluation of your case.

About the Firm: The Michael Brady Lynch Firm is a trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects including Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, Testosterone cardiac events, Mirena IUD,  Xarelto internal bleeding, Actos Bladder Cancer, Lipitor diabetes cases, and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.

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