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FDA pushing back against testosterone booster prescriptions

December 21st, 2015

After a sharp increase in testosterone booster prescriptions and profits over the past 10 years, the U.S. Food and Drug Administration has institute new rules to inform consumers and crack down on unnecessary or questionable low testosterone diagnoses in men. In March, the FDA announced 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” and that “the benefits and safety of this use have not been established.”

As part of the new FDA rules, companies who manufacture testosterone must warn doctors about an increased risk in strokes and heart attacks in patients who use the product. They must also inform patients that many of their testosterone boosters have not actually been approved to treat “Low T,” a marketing term created to describe decreased energy and libido that is often just a sign of aging.

After aggressive marketing practices by testosterone manufacturers, profits for Low T drugs have reached nearly $10 billion and led to more than 25 million prescriptions. In many instances, low testosterone diagnoses are not conducted properly, leading to what some doctors consider to be an overprescribing of a product whose efficacy is not proven.


Washington Post

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