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FDA requires heart/stroke warnings on ‘low-T’ drugs — and cautions against overprescribing

The FDA is requiring companies that sell testosterone products to conduct well-designed clinical trials to determine the drugs’ health risks.

Companies that sell prescription testosterone medications (those “low T” gels, patches and other products advertised aggressively on television) must make it clear to consumers that the drugs are associated with an increased risk of heart attack and stroke, said the U.S. Food and Drug Administration (FDA) in a new safety communication posted on the agency’s website Tuesday.

The FDA also warned the companies that their products’ labels must explain that these medications are approved “only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause hypogonadism.”

The agency acknowledged (with remarkable understatement, given how ubiquitous the marketing of “low-T” products are these days) that it “has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”

The FDA also said the diagnosis of a recognized low-testosterone medical disorder needs to be confirmed by a laboratory test before any drugs are prescribed. As the agency reported last year, about one in five men who receive a prescription for testosterone never undergo a lab test to determine if the treatment is really needed.

The new safety communication also stated that the FDA is requiring companies that sell testosterone products to conduct well-designed clinical trials to determine the drugs’ health risks.

A year in the making

These new requirements come more than a year after the FDA announced, in January 2014, that it was investigating the potential risk of heart attack and stroke in men who were taking testosterone medications. And last summer, an FDA advisory panel voted overwhelmingly to recommend changing the label on testosterone products to keep them from being overprescribed to otherwise healthy men for common symptoms associated with aging, such as a declining sexual drive or fatigue.

As the FDA acknowledged in its safety communication on Tuesday, some studies have found a link between testosterone treatments and a higher risk of heart disease, while others have not. But ‘based on our findings,” said the agency, “we are requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use.”

The FDA also warned men who are using the products to seek medical attention immediately if they have any symptoms of a heart attack or stroke: chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body and/or slurred speech.

The new warning from the FDA follows a similar one issued by Canadian health officials last July. In Europe, however, health officials have decided that there is “no consistent evidence” testosterone products raise the risk of heart problems, although they have urged doctors to confirm a lack of testosterone in patients with a lab test before prescribing the drugs.

Will it make a difference?

Whether this new labeling requirement will have any effect on the overprescribing of testosterone products remains to be seen. 

Some 2.3 million people received a prescription for testosterone medication in 2013 — up from 1.3 million only three years earlier, in 2010, according to FDA numbers.

U.S. sales of the drugs totaled a staggering $2 billion in 2013, according to business media reports.

On Tuesday, Public Citizen’s Health Research Group, a consumer advocacy organization based in Washington, D.C., criticized the FDA for not issuing the warning earlier and for rejecting Public Citizen’s demand last year that the warning be the strongest type that the FDA can make — a so-called black-box warning on a drug’s package insert.

“In the seven and a half months since the Canadian action, approximately four million prescriptions have been filled in the U.S.,” said Dr. Sidney Wolfe, the group’s founder and senior adviser, in a statement. “Had the FDA made this announcement last summer when the Canadian government acted, it would have reduced the number of U.S. prescriptions for and damage from testosterone, a medication of questionable effectiveness for a large proportion of users and one that increases the risk of heart attacks and strokes.”

You can read the FDA’s safety communication on the agency’s website. (Full disclosure: Many, many years ago, I worked with Dr. Sidney Wolfe at a group that was a forerunner to the Health Research Group.)

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