Expert Panel Suggests FDA Review of Testosterone Drug Labels
On Wednesday, a panel comprised of health experts voted overwhelmingly for the U.S. Food and Drug Administration (FDA) to restrict the marketing of low-testosterone drugs, an industry currently enjoying a multibillion-dollar sales boom.
Only one member of the 20-person panel voted against changing testosterone drug labeling to dissuade their use by male patients who may not have actual low testosterone symptoms. Many of these consumers are influenced by television commercials and advertisements citing improved sex drive, weight loss, increased muscle mass, and more.
The panel also expressed concern over the availability of these drugs, the use of which has quadrupled over the past decade. The indications for treating a true testosterone deficiency are very different from the reasons many men have decided to ask their doctor about such treatments. Doctors have been prescribing low-T medications for symptoms of aging, like low libido and energy loss, which are not necessarily indications of low testosterone.
The FDA panel explained that the goal is to change the labeling and more strictly regulate the marketing of these drugs to avoid unnecessary prescriptions.
In the past, the FDA has admitted that the benefits of testosterone therapy to healthy men are less than clear, and that the medications are risky. While a label change might offer some influence, doctors may still prescribe the drugs as they see fit.
In a market mired in misleading benefits and little oversight, testosterone therapy has exploded into the multi-billion dollar industry it is today.