FDA Panel Supports Limits on Testosterone Drugs

After months of concern about the heart risks posed by testosterone drugs, an expert panel formed by the FDA strongly approved placing strict limits on pharmaceutical companies that manufacture the drugs.

As reported in the New York Times last week, the panel advised the FDA to restrict label information to make clear that the medicines are meant only to treat serious medical conditions, not complaints related to normal aging, such as low energy and libido.

Men for whom testosterone might be appropriate are those diagnosed with hypogonadism, a testosterone deficiency – the body doesn’t produce enough of the hormone, which can cause infertility, osteoporosis and enlargement of the breasts.

Although the panel’s decision isn’t binding, the FDA generally accepts the recommendations of its expert panels. Only one of the panel’s 21 members voted against the restriction.

As we’ve written, (see our blog,“FDA to Require Blood-Clot Warning on Testosterone Labels.”) in recent years testosterone has been increasingly prescribed for men to moderate symptoms of aging. The Times pegs the number of testosterone users at more than 2 million.

But the drugs were developed to treat serious, not just uncomfortable, conditions, and studies have shown a higher incidence of heart problems among men who take testosterone.

If the feds adopt the panel’s recommendations, it might reduce the number of men who get the meds, and suppress the over-the-top marketing of them. “Low-T” ads do not address a disease – they’re an effort to expand the drug’s market beyond people who are really ill.

Also, tighter restrictions could prompt insurance plans to deny coverage of testosterone for some patients.

But because doctors are allowed to prescribe medicine for any reason they deem appropriate, the number of testosterone users could remain too high for safety purposes.

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