FDA to Middle-Aged Men: You Probably Don’t Need Testosterone Therapy

Mj 618_348_fda votes to tighten testosterone treatment restrictions
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A Food and Drug Administration panel of top doctors voted 20 to 1 to clamp down on testosterone treatments. The group fears the pills, gels, and creams can cause blood clots, and possibly heart attacks, while offering no real benefit to most men who use them. If the FDA adopts the experts’ recommendations — which it usually does — it will deter doctors from prescribing these treatments to millions of men who don’t really need them. It will also stop drug companies from marketing testosterone therapies as a cure-all for everything from low energy to lackluster sex drive.

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Although testosterone treatments have been approved by the FDA since the 1950s, these drugs used to be given only to guys with low testosterone tied to a serious medical issue, such as undescended testes or testicular damage due to trauma or chemotherapy. However, use of these treatments has surged over the last 15 years, mostly among men ages 40 to 64 whose low testosterone levels are merely a natural result of aging. Between 2010 and 2013 alone, the number of prescriptions doled out to this age group rose from 1.3 million to 2.3 million, according to FDA estimates. But only half of these men had been diagnosed with hypogonadism (when testosterone levels fall below what’s considered normal for a young, healthy man), and 25 percent didn’t even have their levels checked before starting treatment.

The problem is that testosterone treatments were never intended for men without serious medical conditions. And there’s no proof that they offer any real benefit to otherwise healthy guys with low testosterone.

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“The FDA never approved these therapies for men with low T of aging,” says Dr. Lisa Schwartz, a professor at the Dartmouth Institute for Health Policy and Clinical Practice. “However, the way the drug information was written made it seem that if you had low T for absolutely any reason, you could treat it. It isn’t clear that these drugs are not approved for those men.”

This murky verbiage has allowed drug companies to launch multimillion-dollar marketing campaigns to lure as many men as possible into “fixing” their low T. “Companies are targeting healthy men with low testosterone levels,” Schwartz says. “They’re trying to get them to believe that symptoms like feeling tired after they eat, being grumpy, or having low energy are all because of low testosterone. But we don’t know if these drugs offer any benefit for those symptoms.”

They may in fact be harmful. A recent study found that testosterone therapies doubled the heart attack risk for men over age 65 and for younger men with a history of heart disease after only three months of use. And in June the FDA began requiring drug manufacturers to include a warning label on product packaging, stating that these treatments may cause blood clots.

Schwartz says they may also increase PSA levels, an indicator of prostate cancer risk, although they haven’t been proven to increase the risk. “Given these potential harms and the fact that these are unproven therapies for men with low T of aging,” she says, “what’s going on right now is a huge uncontrolled experiment.”

That’s exactly why the FDA convened this panel to take a hard look at testosterone treatments, how they’re marketed, and who is using them. The doctors reviewed piles of recent research and heard testimony from drug companies about the safety studies they’ve conducted. Based on the facts presented, they voted overwhelmingly to tighten up the indications for these drugs, meaning, the definitions of who they are intended for.

“If the FDA follows the panel’s recommendation, it will change the way these indications are written, which will have important implications for how, and to whom, doctors prescribe testosterone treatments,” Schwartz says.

“Doctors can continue to prescribe at their discretion, but insurance companies may not cover these drugs in cases when it’s clear the FDA is saying, ‘No, no, no. We haven’t evaluated these drugs for this particular use.’” Requiring more specified — and accurate — indications will also prevent drug companies from advertising their products as remedies for symptoms they may not actually alleviate.

The panel also voted in a landslide to require drug companies to conduct more testing for cardiovascular risks, a move Schwartz applauds. But for the time being, she says it’s best to be cautious. So if you don’t have a serious medical problem, and you’re just looking to get your mojo back, “don’t use testosterone treatments,” says Schwartz.

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