PMID- 29960004
OWN - NLM
STAT- MEDLINE
DCOM- 20190509
LR  - 20190509
IS  - 1527-9995 (Electronic)
IS  - 0090-4295 (Linking)
VI  - 120
DP  - 2018 Oct
TI  - A Review of the FAERS Data on 5-Alpha Reductase Inhibitors: Implications for 
      Postfinasteride Syndrome.
PG  - 143-149
LID - S0090-4295(18)30590-9 [pii]
LID - 10.1016/j.urology.2018.06.022 [doi]
AB  - OBJECTIVE: To quantify reports made to the Food and Drug Administration Adverse 
      Event Reporting System (FAERS), create a demographic of patient reports, and 
      examine the cluster of symptoms to correlate consistency of postfinasteride 
      syndrome (PFS) complaints. PFS is a provisional diagnosis encompassing a cluster 
      of sexual, physical, and psychological and/or neurologic symptoms associated with 
      5-alpha reductase inhibitor use that emerge or continue after discontinuation of 
      medication. MATERIALS AND METHODS: FAERS dataset of 5-alpha reductase inhibitors 
      from April 2011 to October 2014 was obtained. Each FAERS report had 16 categories 
      for completion, but not every report was fully completed. Statistical analysis 
      compared variables of interest between the 2 doses of finasteride (1 mg vs 5 mg). 
      RESULTS: From FAERS, 2048 monotherapy cases were identified: 1581 of finasteride 
      1 mg, 240 of finasteride 5 mg, and 226 of unreported doses. Possibly related to 
      labeling changes, from 2011 to 2014, there was a significant increase in adverse 
      events (AEs) reported involving 1 mg dosing. Finasteride use was reported with 
      many sexual AEs including diminished libido, erectile dysfunction, and 
      ejaculatory complaints. Other common AEs included dermatologic, metabolic, and 
      psychological and/or neurologic complaints. There were more AE reports with the 1 
      mg dose than the 5 mg dose. One case of dutasteride reported back pain, not 
      generally attributed to PFS. CONCLUSION: FAERS data suggests that finasteride 
      exposure is reported with a diverse collection of symptoms, particularly in 
      younger men on 1 mg dosage compared to older men on 5 mg. Many of these 
      complaints fall well out of the realm of previously established AEs from 
      long-term controlled studies.
CI  - Copyright (c) 2018 Elsevier Inc. All rights reserved.
FAU - Baas, Wesley R
AU  - Baas WR
AD  - Southern Illinois University School of Medicine, Springfield, IL.
FAU - Butcher, Michael J
AU  - Butcher MJ
AD  - Southern Illinois University School of Medicine, Springfield, IL; Park 
      Nicollet/Health Partners Health System, Minneapolis, MN.
FAU - Lwin, Aye
AU  - Lwin A
AD  - Southern Illinois University School of Medicine, Springfield, IL.
FAU - Holland, Bradley
AU  - Holland B
AD  - Southern Illinois University School of Medicine, Springfield, IL.
FAU - Herberts, Michelle
AU  - Herberts M
AD  - Southern Illinois University School of Medicine, Springfield, IL.
FAU - Clemons, Joseph
AU  - Clemons J
AD  - Southern Illinois University School of Medicine, Springfield, IL.
FAU - Delfino, Kristin
AU  - Delfino K
AD  - Southern Illinois University School of Medicine, Springfield, IL.
FAU - Althof, Stanley
AU  - Althof S
AD  - Center for Marital and Sexual Health of South Florida, West Palm Beach, FL; Case 
      Western Reserve University School of Medicine, Cleveland, OH.
FAU - Kohler, Tobias S
AU  - Kohler TS
AD  - Southern Illinois University School of Medicine, Springfield, IL.
FAU - McVary, Kevin T
AU  - McVary KT
AD  - Male Health, Strich School of Medicine, Loyola University Medical Center, 
      Maywood, IL. Electronic address: kmcvary@siumed.edu.
LA  - eng
PT  - Journal Article
DEP - 20180627
PL  - United States
TA  - Urology
JT  - Urology
JID - 0366151
RN  - 0 (5-alpha Reductase Inhibitors)
RN  - 57GNO57U7G (Finasteride)
SB  - IM
MH  - 5-alpha Reductase Inhibitors/administration & dosage/*adverse effects
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Age Factors
MH  - Datasets as Topic
MH  - Dose-Response Relationship, Drug
MH  - Drug Eruptions/epidemiology
MH  - Fatigue/chemically induced/epidemiology
MH  - Finasteride/administration & dosage/*adverse effects
MH  - Gynecomastia/chemically induced/epidemiology
MH  - Hearing Disorders/chemically induced/epidemiology
MH  - Humans
MH  - Libido/drug effects
MH  - Male
MH  - Memory Disorders/chemically induced/epidemiology
MH  - Middle Aged
MH  - Muscle Weakness/chemically induced/epidemiology
MH  - Prostatitis/chemically induced/epidemiology
MH  - Sexual Dysfunction, Physiological/chemically induced/epidemiology
MH  - Sleep Wake Disorders/chemically induced/epidemiology
MH  - United States/epidemiology
MH  - United States Food and Drug Administration
EDAT- 2018/07/01 06:00
MHDA- 2019/05/10 06:00
CRDT- 2018/07/01 06:00
PHST- 2017/09/20 00:00 [received]
PHST- 2018/05/31 00:00 [revised]
PHST- 2018/06/14 00:00 [accepted]
PHST- 2018/07/01 06:00 [pubmed]
PHST- 2019/05/10 06:00 [medline]
PHST- 2018/07/01 06:00 [entrez]
AID - S0090-4295(18)30590-9 [pii]
AID - 10.1016/j.urology.2018.06.022 [doi]
PST - ppublish
SO  - Urology. 2018 Oct;120:143-149. doi: 10.1016/j.urology.2018.06.022. Epub 2018 Jun 
      27.