A U.S. Food and Drug Administration (FDA) advisory panel voted 20-1 Wednesday to impose strict new limitations on testosterone-replacement drugs, recommending changes to labeling that would limit FDA-approved prescription indications to men who have abnormally low testosterone levels due to injury or disease, but not aging.
The changes, triggered by conflicting studies and a lack of evidence showing the efficacy of testosterone drugs for treating common age-related issues, would exclude millions of American men who currently use the drugs as antidotes for low libido, muscle loss, and lack of energy.
The panel’s recommendations, which the FDA usually accepts, could also cut into the earnings of pharmaceutical giants that are pulling in billions of dollars in profit from the blockbuster drugs. Testosterone drugs have soared in popularity in recent years, propelled by aggressive advertising campaigns that push the drugs as panaceas for “Low T” and age-related symptoms.
Currently there are 21 prescription testosterone-replacement therapies available in the U.S., with more in pipeline awaiting testing results or FDA approval. These drugs are available in the form of topical gels, patches, pills, and injections.
AbbVie’s Androgel and Eli Lilly’s Axiron have dominated the “Low-T” drug market for years. Altogether, testosterone drug prescriptions have soared nearly 60 percent since 2010 to 4.8 million last year and analysts have expected these numbers to climb as drug titans continually pedal the remedies directly to consumers through television, print, and internet ads.
The FDA panelists also reviewed evidence that testosterone-replacement drugs could be linked to heart attacks and blood clots. Although the panel said that such studies were inconclusive, it voted in favor of requiring drug manufacturers to conduct long-term studies of the effects of testosterone drugs on cardiovascular health.
The FDA called for an outside review of the safety and efficacy of testosterone drugs earlier this year, after Canadian regulators issued stronger warnings about the drugs. Briefing documents published on the FDA’s website say that while testosterone levels commonly drop in men as they age, studies indicate that lower levels of the hormone do not necessarily lead to serious health problems, and that there is a lack of evidence supporting the benefits of the drugs in treating conditions linked to aging.