FDA to reassess appropriateness, usefulness of testosterone replacement drugs

Low T FDA to reassess appropriateness, usefulness of testosterone replacement drugsThe U.S. Food and Drug Administration (FDA) will hold an advisory panel meeting Sept. 17 on the safety and usefulness of testosterone replacement drugs, which a number of pharmaceutical manufacturers are promoting and selling aggressively to men who may be stricken with low testosterone levels, or “Low T.”

FDA officials added briefing documents to the agency website earlier this month, acknowledging 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, such as testicular and pituitary disease.

Still, as the agency notes, testosterone drug use has escalated substantially within the last five years despite the lack of evidence supporting the benefits. “The need to replace testosterone in these older men remains debatable,” the agency says.

Last year, 2.3 million patients were treated with testosterone replacement drugs, up from 1.3 million in 2010. About 70 percent of the men who received a testosterone drug prescription were between the ages of 40 and 64. Only half the men taking testosterone prescriptions had actually been diagnosed with low testosterone, the agency noted, and a quarter of testosterone patients hadn’t received any form of testing for testosterone levels before starting the therapy.

The FDA said that the number of men receiving testosterone prescriptions without prior testing was “particularly concerning” because a low-testosterone diagnosis requires documented evidence of low or absent testosterone concentrations. Without testing testosterone levels, there is no way a proper dose can be determined, the FDA noted.

“There are no reliable data on the benefit in such a population,” the FDA said of testosterone drugs and their escalating use. As such, the main goal of the planned advisory meeting is to “reassess the appropriate patient population for testosterone replacement therapy and to ensure that the labeling for FDA-approved testosterone therapies appropriately reflects the population for whom therapy is indicated.”


Wall Street Journal
Food and Drug Administration