Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Labeling of Selective Androgen Receptor Modulators

JAMA; 2017 Nov 28; Van Wagoner, Eichner, et al

In products marketed as selective androgen receptor modulators and sold via the internet, most contained unapproved drugs and were inaccurately labeled. This according to a limited investigation involving chemical analyses of 44 products marketed as selective androgen receptor modulators, which have not been approved by the US Food and Drug Administration (FDA). Web-based searches were performed from February 18, 2016, to March 25, 2016, to identify suppliers selling selective androgen receptor modulators. The products were purchased and the identities of the compounds and their amounts determined from April to August 2016. Researchers found:

  • Only 52% of the products tested contained selective androgen receptor modulators and another 39% contained another unapproved drug.
  • Additionally, 25% of products contained substances not listed on the label and 9% did not contain an active substance.
  • 59% of products contained substance amounts that differed from the label.

Citation:

Van Wagoner RM, Eichner A, Bhasin A, Deuster PA, Eichner D. Chemical composition and labeling of substances marketed as selective androgen receptor modulators and sold via the internet. JAMA. 2017;318(20):2004–2010. doi:10.1001/jama.2017.17069.

Commentary:

Selective androgen receptor modulators are a new class of performance-enhancing substances that are nonsteroidal but show affinity as agonists at the androgen receptor. They have been shown to have anabolic properties in rodents, and, while some early clinical trials showed anabolic activity in older individuals, other trials in other groups of patients have not shown such effects.1 The safety of this class of agents is not well described. The frequency of use of body enhancing substances is much greater then generally appreciated in clinical practice, since most of our patients who use anabolic steroids do not admit to their use. One study estimated lifetime prevalence of use to be 6% for men and 2% for women.2 This level of use is concerning since the side effects of anabolic steroids include cardiomyopathy in approximately 70% of current users, aggression, cognitive dysfunction, dependency, as well as a withdrawal syndrome characterized by muscle loss, fatigue, decreased sex drive and function, and suicidal depression.3 In addition to these concerning side effects, is the concern of how easy they are to obtain over the internet, and how little patients know about what they actually have purchased. —Neil Skolnik, MD

  1. Dalton JT, Barnette KG, Bohl CE, et al. The selective androgen receptor modulator GTx-024 (enobosarm) improves lean body mass and physical function in healthy elderly men and postmenopausal women. J Cachexia Sarcopenia Muscle. 2011;2(3):153-161. doi:10.1007/s13539-011-0034-6.
  2. Sagoe D, Molde H, Andreassen CS, Torsheim T, Pallesen S. The global epidemiology of anabolic-androgenic steroid use. Ann Epidemiol. 2014;24(5):383-398. doi:10.1016/j.annepidem.2014.01.009.
  3. Baggish AL, Weiner RB, Kanayama G, et al. Cardiovascular toxicity of illicit anabolic-androgenic steroid use. Circulation. 2017;135(21):1991-2002. doi:10.1161/CIRCULATIONAHA.116.026945.

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