On September 17th, an advisory panel of the United States Food and Drug Administration (FDA) voted almost unanimously to recommend restrictions on testosterone use in that country.
In a 20-1 vote, the panel called for stricter prescribing guidelines and clinical trials to investigate safety concerns. If the FDA accepts the panel’s recommendations, it could decrease the number of prescriptions written, restrict the marketing of testosterone products, and prompt insurance companies to change their coverage policies.
Testosterone use has become more popular among American men. Background documents distributed by the U.S. Department of Health and Human Services reported that 1.3 million U.S. patients received prescriptions in 2010. By 2013, that number had risen to 2.3 million.
The largest group of testosterone recipients are between 40 and 60 years old, the report said. An FDA analysis showed that 21% of men taking testosterone had not had their levels tested before receiving a prescription.
Experts are concerned that men are taking testosterone for age-related hypogonadism, as testosterone levels naturally decline as men get older.
However, the FDA has not approved the use of testosterone for this circumstance. Officially, testosterone is intended only for men with “classic” hypogonadism caused by problems in the testes, hypothalamus, or pituitary gland. For these men, testosterone is needed to maintain secondary sex characteristics.
The benefits of testosterone therapy are unclear for men who are aging, but in good health.
There are also safety concerns. Some studies have shown increased cardiovascular risk for men taking testosterone, while others have not found an association.
Professionals in the field have mixed feelings about the panel’s recommendations, reports the Urology Times.
“There are many physicians and other providers treating low T without any background, and many are prescribing without proper patient evaluation or follow-up,” Dr. John J. Mulcahy said. Dr. Mulcahy is a member of the Urology Times Editorial Council.
Dr. Abraham Morgentaler of Men’s Health Boston and Harvard Medical School disagreed with the panel’s recommendations.
“The vote by the FDA advisory committee in favor of revising the label on testosterone products so as to restrict their use was a step backwards for our patients and for science,” he told Urology Times.
It is not yet known whether the FDA will adopt the panel’s recommendations.
Medscape Medical News
Tucker, Miriam E.
“FDA Advisory Panel Urges Restrictions on Testosterone Use”
(September 18, 2014)
The New York Times
“F.D.A. Panel Backs Limits on Testosterone Drugs”
(September 17, 2014)
Kerr, Richard R.
“FDA panel’s vote on TRT draws reaction from urologists”
(September 22, 2014)
U.S. Department of Health and Human Services
Nguyen, Christine P., MD and Hylton V. Joffe, MD, MMSc
(August 22, 2014)