This week, the U.S. Food & Drug Administration (FDA) will convene an expert panel to discuss the widespread use of testosterone replacement therapy and its risks of serious medical side effects.
The panel follows up the FDA’s safety announcement, issued in January, noting that it was looking into studies that had shown a possible risk of heart attack, stroke and death in men using testosterone treatments
The panel will be a joint meeting of two outside advisory committees: the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The two primary agenda topics, set for September 17 in Maryland, are:
- The appropriate indicated population for testosterone replacement therapy (TRT), and
- The potential for adverse cardiovascular outcomes associated with use of TRT.
Prior to the meeting, the FDA released a background brief. It stated that 2.3 million men were prescribed testosterone in 2013, which is an increase of 77 percent over 2010. This rise is attributed to heavy direct-to-consumer advertising “emphasizing the benefits of TRT related to quality-of-life, such as vitality and strength, and non-branded disease awareness campaigns of ‘low T’ have targeted a broad population of men.” Data from commercial health insurance claims show the largest group of patients prescribed testosterone is men from 40 to 60 years old.
The FDA emphasized that “more than 20 percent of patients who received a prescription did not have any record that their testosterone levels were measured.” It said this is a problem for the following reason:
“This is particularly concerning because the diagnosis of hypogonadism requires documented evidence of low or absent serum testosterone concentrations and the appropriate TRT dose cannot be determined without following serum testosterone concentrations on therapy.”
While the drug was approved for use for men with low testosterone along with associated medical conditions, the concern is the explosion in marketing of the drug to men who are simply aging. The debate now is over whether the drug is appropriate for this population and whether it poses unnecessary risks.
The FDA backgrounder concluded that there wasn’t much evidence to show that testosterone treatments provided any benefits for men who used the drugs to alleviate typical aging symptoms of fatigue, and low libido.
According to court records, since the FDA’s safety announcement in January, more than 170 lawsuits have been filed in the Northern District of Illinois against the manufacturers of testosterone treatments, including AndroGel, AndroDerm and Testim. The manufacturers include Abbvie, Eli Lilly, Endo Pharmaceuticals and Upshur-Smith Laboratories.
The lawsuits generally allege that the plaintiffs were injured by the use of the testosterone therapy – suffering heart attacks, strokes, blood clots, or other cardiovascular events– and that the manufacturers did not adequately warn patients about the risks.