FDA Panel Unanimously Rules To Restrict Testosterone Drugs

A panel of experts has offered its opinion to the FDA suggesting that the agency take measures to restrict the advertising and prescribing of testosterone medications. The New York Times (NYT) reports that the panel reached this decision after hearing testimony and examining evidence that these treatments may increase risk of heart attack and stroke while offering no real health benefits.

Testosterone represents a multi-billion dollar pharma business. The most popular products include pills, gels, and injections from companies such as AbbVie and Eli Lilly.

Originally only intended to treat serious conditions, prescriptions for testosterone treatments have quadrupled since 2001, with over 60 percent coming from general practitioners for the treatment of “low-t”

Experts suggest that “low-t” is not necessarily the health risk that drug advertisers have indicated. Symptoms for “low-t” include decreased libido, redistribution of body fat, and hair loss.  Experts argue that these symptoms are common signs of aging and more often than not, are no real cause for concern.

Michael Domanski, director of heart failure research at Mount Sinai, explains, “The whole idea is to try to reign in the inappropriate advertising and use of these drugs.”

The use of these drugs for lifestyle reasons is a subject of major concern because of recent research that suggests a link between these treatments and increased risk of heart attack and stroke. This research prompted the FDA to issue a safety announcement in January that urged doctors to practice caution while additional research was conducted.

In the advisory, the FDA explicitly stated that, “None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.”

Still, the panel believes that the FDA could take measures to clarify the specific and sanctioned use for these treatments. Marjorie Shaw Phillips, panelist from Georgia Regents Medical Center, told the Seattle Times, “I think the current labeling is vague and has been subject to misinterpretation.”

The National Institute of Health (NIH) is supporting a study that would reassess the safety and efficacy of testosterone medications in men over the age of 65, and experts encourage additional research in younger men who make up a large portion of the consumer base.

Richard Hodes, Director of the National Institute of Aging (NIA) issued a statement that illustrated the need for further research and evaluation for testosterone treatments. He said, “We know that, as men get older, a significant proportion are unable to carry out activities of daily living and experience decreased physical and cognitive function…We do not know the extent to which low levels of testosterone may contribute to these conditions.”

The results of the NIH study are expected next year.