FDA Panel Backs Limits on Testosterone Drugs

An expert panel has voted for the F.D.A to impose strict new limitations on the testosterone industry. The panel recommends that the agency tighten labels for the medicines so they are not prescribed to men who only have problems related to aging, such as low energy or libido. The agency will likely take the advice of the expert panel.

The testosterone drug industry is a multibillion-dollar industry with over two million Americans using the drugs, mostly for symptoms that are largely related to aging. If the F.D.A takes the advice of the panel, it could reduce the number of men prescribed the medicines significantly, which will ultimately cut down on marketing of the drugs all together. It could also limit coverage from insurance companies for their use.

“The whole idea is to try to rein in the inappropriate advertising and use of these drugs,” said Dr. Michael Domanski, the director of heart failure research at Mount Sinai School of Medicine, who was one of 20 members on the panel who voted to change the labeling. Just one member voted against the change.

Some experts were skeptical that usage would change much, because doctors could prescribe the drugs as they see fit, despite what it says on the label.

One question the F.D.A had for the panel was if they should approve a new oral testosterone drug, AbbVie, the company that makes AndroGel, a testosterone treatment. Testosterone replacement therapy is an important men’s health topic.

The F.D.A. has said that the benefits of testosterone treatments for healthy, aging men are unproven, and that the drugs could be risky. Men who take them have been found to have higher rates of heart problems in some studies.

The FDA is reassessing the safety of testosterone products in light of recent studies and would investigate rates of stroke, heart attack and death in men using the drugs.

One of the problems had been the vagueness of testosterone drug labels, which many doctors have interpreted to include any man with low testosterone. Panelists say the label should be limited to men only with serious medical conditions, such as pituitary gland issues.

The panel was also asked to go through evidence of safety risks. It found that the evidence for risks of heart problems was mixed, and all but one of its members voted to require clinical trials for safety for at least some types of testosterone therapy.

Read the full article from the NYTimes here.