Last month the Food and Drug Administration made several cautious moves to reign in the widespread of testosterone replacement therapy drugs used to treat “Low-T.”
First, an advisory panel with the FDA voted to recommend strict new limitations on low-T drugs. If the FDA accepts the panel’s recommendations, prescriptions of low-T drugs would be severely curtailed and limited to patients with serious medical conditions affecting the testicles.
Secondly, two days later the same panel voted to reject a new oral low-T drug called Rextoro, made by Clarus Therapeutics. Rextoro was advertised as the first testosterone replacement therapy in capsule form. According to the Wall Street Journal, the panel voted 18-3 against approval, saying that the benefit-risk profile of the drug was sufficient to approve it. Panel member, A. Michael Lincoff, vice chairman of cardiovascular medicine at the Cleveland Clinic, said some members of the committee were concerned that an oral testosterone product “might tend to be used more off-label”—that is, for lifestyle and not medical reasons.
Testosterone-replacement drugs are intended for men who, for genetic or disease reasons, have low testosterone. But in recent years drug companies have begun to shamelessly market their testosterone-boosting drugs to doctors and the public, promoting it as a product that can overcome a supposed disease called “low T.” According to the marketing low-T is characterized by feelings of fatigue, loss of sexual drive, depressed moods, an increase in body fat and decrease in muscle strength, among other symptoms – all common problems associated with aging.
What pharmaceutical companies have not disclosed is the increasing body of research that links testosterone therapy to significant cardiovascular risks – specifically heart attacks and strokes. A recent analysis by Public Citizen of independent studies going back as far as 20 years showed a “highly significant” increased cardiovascular risk.
The FDA is to be commended for taking these first restrictive steps, but it is not enough. Too many healthy men, spurred on by a relentless advertising campaign being waged by pharmaceutical companies, are taking these drugs as a lifestyle choice and risking heart attacks or strokes. Testosterone therapy should be taken as a medical necessity and not for a disease made up by drug companies –“low-T”- to create a new $2 billion revenue stream.
The risks of taking testosterone replacement drugs are clear, and the FDA needs to continue act clearly and decisively to prevent more healthy men from being harmed.