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FDA Panel Wants to Limit Testosterone Drugs

Anyone who watches television has seen the commercials advertising prescription drugs designed for men suffering from “low T,” or low testosterone. The picture these commercials paint is that any of the discomforts of aging can be magically cured with a pill or cream. However, that may be about to change.

Panel Recommends New Labels

The New York Times reports that a panel of twenty medical experts voted this week for the Food and Drug Administration (FDA) to impose new limitations on the testosterone drug industry. The panel recommended that the agency tighten the labeling of these drugs so they are not prescribed to men who are only experiencing the effects of getting older, such as decreased energy and libido. Decreased testosterone is a perfectly normal part of aging. Most men start to see their testosterone levels gradual drop at some point in their thirties. Of course, there are some men who suffer from dramatic drops in testosterone due to a medical problem. Those men are exactly the men who the panel would say should be treated with these drugs.

While the FDA is not required to do what the panel tells it to do, the agency usually follows the advise of such expert panels. If the FDA does follow the recommendation, it could affect both the advertising of these drugs and whether insurance companies cover them.

It used to be that testosterone drugs were only taken for serious medical conditions. However, now over two million men in America are on the drugs. And most of them are taking the drugs to treat aging. According to the FDA, the benefits of testosterone treatments for men who are perfectly healthy and are just aging are unproven. Meanwhile the drugs carry side effects and some studies indicate they could lead to heart problems.

Of course, even if the FDA follows the panel’s recommendations, the practice of using these drugs to treat normal aging will not be snuffed out. Doctors will still have the ability to prescribe the medication “off-label,” that is, for reasons other than the specifically approved reasons. However, at least if the labeling on the product explains that it is not to be used to treat aging, patients may be better informed and might ask more questions about the risks and rewards of the treatment.

FDA Rejects Oral Testosterone Replacement Drug

In a related story, an FDA advisory committee rejected a new testosterone-replacement drug called Rextoro this week, reports The Wall Street Journal. The committee decided that the benefit-risk profile of the drug was not sufficient to approve it. One member of the panel, Dr. A. Michael Lincoff, reported that members of the committee were concerned that an orally administered testosterone pill like Rextoro “might tend to be used more off-label.” In other words, the theory is that oral testosterone replacements are more likely to be used to treat normal aging than other methods of testosterone replacement.

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