On label and off label drug use in reproductive medicine

Off-label drug use is common for treatment of reproductive disorders. Clinician awareness of US Food and Drug Administration indications for drug use is essential to proper communication with patients regarding the risk-benefit ratios of treatments.

Richard Legro, M.D

Volume 103, Issue 3, Pages 581-582


This Views and Reviews article examines FDA-approved uses of prescription drugs, as well as common off-label uses of drugs for several disorders that are frequently seen in reproductive medicine. Off-label drug use is ubiquitous in reproductive medicine, a fact that may be related to the disincentives to formally study these drugs in a potentially vulnerable population (i.e., pregnant women). It behooves clinicians to discuss with patients the risk-benefit ratio of treatment, and whether a treatment is FDA-approved for that condition. Researchers, seeking better data on effects of these drugs, may find fodder for future clinical studies in these articles.

  • Excellent review of the main EMTs used for idiopathic male infertility. This is a very frustrating and difficult problem for us to address given the limited options. We are much better at correcting the hormonal problem of hypogonadism. However even thought the Cochrane review from 2000 demonstrated a 27% pregnancy rate compared to 0% with the no treatment group, the current pregnancy outcomes have been variable and different groups continue to have contradictory results with each other. Double blind placebo controlled RCTs are going to be difficult to come by given the nature of what we are trying to treat and the oftentimes limited time frame in which to achieve results. I do concur that additional studies are needed to improve our understanding of what we are trying to accomplish and how to get there.

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