FDA Panel Wants to Limit Testosterone Rx Use

With testosterone replacement therapy prescriptions on the rise, panel votes to limit use

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Concerned about a potential increased risk of heart-related conditions, a US Food and Drug Administration (FDA) committee has suggested limits to the use of testosterone replacement therapy (TRT).

Testosterone should be given to men with testicular problems like tumors, the panel voted, but not to treat so-called low T. Low T refers to an age-related loss of testosterone tied to a decreased sex drive.

The panel also called for more study into the effects of TRT on heart health.

The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met in joint session Sept. 17. The joint panel heard staff reports and discussed recommendations before taking votes. The FDA is not required to do what its panels ask. A panel vote does not necessarily mean the FDA will act on that vote.

In 2010, 1.3 million men received a prescription for a testosterone product, the FDA reports. By 2013, 2.2 million patients were using one — a 76 percent increase.

TRT has been around since the 1950s. It was first used to treat men whose bodies were not making the hormone, which aids in sexual maturation and the development of male body traits.

Christine P. Nguyen, MD, the CDC’s deputy director for safety, wrote in a summary report that TRT use has expanded to treating age-related loss of testosterone.

From 2009 to 2013, sales of TRT products, sold under brand names like AndroGel and Axiron, increased by 65 percent, according to the FDA.

Only 25 percent of the men prescribed TRTs had their testosterone levels checked before taking the TRT. Dr. Nguyen called that “particularly concerning.”

“Direct-to-consumer advertisement 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,” Dr. Nguyen wrote.

The panel also looked at the association between TRT and an increased risk of heart problems. The FDA initially studied that tie in 2010 — and again in a 2014 study.

That trial suggested a 30 percent increased risk of “adverse cardiovascular events” in men on TRT.

Dr. Nguyen cited a second study on the topic but noted many limitations to the current body of research, such as small sample sizes and short treatment and follow-up times.

The joint panel voted 20 to 1 to tighten up use of TRT by labeling the medicines for men with medically significant low testosterone only — although doctors would still be able to prescribe TRT at their discretion.

This restriction, if the FDA implements it, could also stop manufacturers from advertising TRT for age-related testosterone loss, Dr. Nguyen noted.

The panel also voted in favor of requiring manufacturers to conduct trials on the potential link between TRT and heart problems.

Review Date: 
September 23, 2014
Last Updated:
September 25, 2014