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Ongoing Concerns Regarding Finasteride for the Treatment of Male-Pattern Androgenetic Alopecia

Ongoing Concerns Regarding Finasteride for the Treatment of Male-Pattern Androgenetic Alopecia Opinion EDITORIAL Ongoing Concerns Regarding Finasteride for the Treatment of Male-Pattern Androgenetic Alopecia Roger S. Ho, MD, MS, MPH Since its approval for the treatment of male-pattern androge- in clinical trials. Such was the case with finasteride. The as- netic alopecia by the United States Food and Drug Adminis- sociated reporting bias, along with the lack of power, may re- tration in 1997, finasteride has continued to be at the center sult in many missed associations. Plagued by these biases and of many controversies regard- heterogeneity, even meta-analyses of these clinical trials may ing its adverse events. Al- not provide prescribers a full picture of the drug’s adverse Related article page 35 though sexual adverse events events. were included in the original A way to explore the potentially missed adverse events of label of finasteride, little attention was initially paid to the 2002 a drug is through analyzing adverse drug event databases via elimination of the word “all” in the drug monograph regard- a validated pharmacovigilance methodology. The now well- ing sexual adverse events, changing the language from “reso- known risk of a serum sickness–like reaction related to cefa- lution occurred in all men who discontinued therapy” to “reso- http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Dermatology American Medical Association

Ongoing Concerns Regarding Finasteride for the Treatment of Male-Pattern Androgenetic Alopecia

JAMA Dermatology , Volume 157 (1) – Jan 11, 2021

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Publisher
American Medical Association
Copyright
Copyright 2020 American Medical Association. All Rights Reserved.
ISSN
2168-6068
eISSN
2168-6084
DOI
10.1001/jamadermatol.2020.3384
Publisher site
See Article on Publisher Site

Abstract

Opinion EDITORIAL Ongoing Concerns Regarding Finasteride for the Treatment of Male-Pattern Androgenetic Alopecia Roger S. Ho, MD, MS, MPH Since its approval for the treatment of male-pattern androge- in clinical trials. Such was the case with finasteride. The as- netic alopecia by the United States Food and Drug Adminis- sociated reporting bias, along with the lack of power, may re- tration in 1997, finasteride has continued to be at the center sult in many missed associations. Plagued by these biases and of many controversies regard- heterogeneity, even meta-analyses of these clinical trials may ing its adverse events. Al- not provide prescribers a full picture of the drug’s adverse Related article page 35 though sexual adverse events events. were included in the original A way to explore the potentially missed adverse events of label of finasteride, little attention was initially paid to the 2002 a drug is through analyzing adverse drug event databases via elimination of the word “all” in the drug monograph regard- a validated pharmacovigilance methodology. The now well- ing sexual adverse events, changing the language from “reso- known risk of a serum sickness–like reaction related to cefa- lution occurred in all men who discontinued therapy” to “reso-

Journal

JAMA DermatologyAmerican Medical Association

Published: Jan 11, 2021

References