Introduction: on-label and off-label drug use in reproductive medicine.
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.
Department of Obstetrics and Gynecology, Pennsylvania State University College of Medicine, Hershey, Pennsylvania. Electronic address: RSL1@PSU.EDU.
Richard S
RS
Legro
D035843:Biomedical Research / Q000592:standards / Q000639:trends; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004348:Drug Labeling; D004363:Drug Utilization / Q000331:legislation & jurisprudence; D005260:Female; D006801:Humans; D056687:Off-Label Use / Q000191:economics / Q000331:legislation & jurisprudence; D011247:Pregnancy; D063487:Prescription Drug Misuse / Q000331:legislation & jurisprudence; D018456:Reproductive Medicine / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
FDA drug approval; adverse events; clinical trials; drug approval; randomized