Are finasteride-related penile curvature/Peyronie's disease Adverse Event Reports worthy of further clinical investigation? Disproportionality analysis based on both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) pharmacovigilance databases.
Journal
International journal of impotence research
ISSN: 1476-5489
Titre abrégé: Int J Impot Res
Pays: England
ID NLM: 9007383
Informations de publication
Date de publication:
Aug 2023
Aug 2023
Historique:
received:
05
04
2021
accepted:
22
03
2022
revised:
22
01
2022
medline:
13
7
2023
pubmed:
6
5
2022
entrez:
5
5
2022
Statut:
ppublish
Résumé
A limited number of studies have described patients on finasteride showing findings which were consistent with Peyronie's disease (PD). We aimed to detect a pharmacovigilance signal of possible association between finasteride and PD-related clinical features. The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database was queried to identify the ten drugs which were associated the most with the adverse drug reactions (ADRs) recorded as "penile curvature" and/or "Peyronie's disease". A similar analysis, including the same drugs, was carried out for the EMA (European Medicines Agency) EudraVigilance (EV) database. Descriptive data have been analyzed, and Proportional Reporting Ratios (PRRs) have been computed against the other nine drugs of the database. Overall, 860 reports of "penile curvature" and/or "Peyronie's disease", were identified in the FAERS database, 214 of which (24.9%) were associated with finasteride. Most reports (56.9%) were submitted by healthcare professionals. Where a treatment-indication was stated, the vast majority of reports (176/210; 83.8%) were associated with androgenetic alopecia. The outcome of most ADRs was "serious" (82.2%), with 96 ADRs resulting in levels of permanent disability. For 97/214 individual cases, penile curvature/PD reports were not part of a syndromic cluster suggestive of post-finasteride syndrome (PFS). The PRR resulted 6.6 (95% CI: 5.6-7.8) and 11.8 (95% CI: 9.08-15.33), respectively, in the FAERS and in the EV databases. Notwithstanding the related limitations and biasing factors of pharmacovigilance studies based on spontaneous reporting, the PRR values here identified should be interpreted as strong signals of disproportionality. These findings, per se, are however not useful to confirm any causal association. Clinical studies are needed to investigate on the possible role for finasteride in causing PD-related clinical features, an hypothesis which remains highly speculative due to the very questionable quality of present data.
Identifiants
pubmed: 35513712
doi: 10.1038/s41443-022-00568-2
pii: 10.1038/s41443-022-00568-2
doi:
Substances chimiques
Finasteride
57GNO57U7G
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
465-471Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature Limited.
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