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Safety Concerns Slow Sales of Testosterone Therapy

Safety concerns hurt sales of testosterone replacement therapy
Safety Concerns Slow Sales of Testosterone Therapy
Illustration by 731

In recent years television ads promoting testosterone’s powers created a stampede of men searching for a cure for “Low T,” a disease aggressively promoted by testosterone makers AbbVie and Eli Lilly. “These drug companies were running a broad information campaign telling people, ‘Hey, do you sometimes feel a little tired? Talk to your doctor about Low T.’ That was an entrée to testosterone drugs,” says Steven Woloshin, professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice.

Concerns from the U.S. Food and Drug Administration could put the brakes on sales. In a September hearing, an advisory panel to the FDA voted 20 to 1 to revise the labels of testosterone drugs such as AbbVie’s AndroGel and Lilly’s Axiron to make it clear the products should be prescribed only to men with serious testosterone deficiencies—not to average graying guys facing the hormonal decline that comes with age. Most panelists also urged the agency to require testosterone makers to begin safety trials in the wake of several independent studies run by academic institutions suggesting the drugs raise the risk of heart attack and stroke.