A summary of the controversy surrounding off-label medications in men’s health
| Autor: | Matthew Bruha, Adam Parker, Oluwaseun Akinola, Charles Welliver |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Drug
medicine.medical_specialty Urology media_common.quotation_subject Hormone replacement andrology Review Article Normal aging Pharmacology Off-label use Male infertility Food and drug administration 03 medical and health sciences 0302 clinical medicine off label Medicine 030212 general & internal medicine controversy media_common 030219 obstetrics & reproductive medicine business.industry medicine.disease Reproductive Medicine Family medicine business Male factor infertility |
| Zdroj: | Translational Andrology and Urology |
| ISSN: | 2223-4691 2223-4683 |
| DOI: | 10.21037/tau.2016.03.07 |
| Popis: | While there are common and accepted practices in men's health, barriers exist to treatment of these disorders with Food and Drug Administration (FDA) approved medications. In male factor infertility, these barriers include studies that are often underpowered for desired outcomes. This has led to the use of medications previously examined in females in an off-label fashion for treatment of male infertility. Issues surrounding the treatment of hypogonadism in men are more complex, becoming increasingly so in the last few years. Drug companies have developed compounds for treatment of hypogonadism for particular subgroups of men. However, the indicated groups for these medications are narrow leading to these medications being regularly used for an indication the FDA considers to be part of "normal aging". This work will examine the controversy surrounding the use of off-label medications in men's health and how factors like pharma advertising, FDA regulation and difficulties in creating adequate studies has affected the current paradigm. |
| Databáze: | OpenAIRE |
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