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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. / Schifano, Nicolo; Cappogrosso, Paolo; Boeri, Luca; Fallara, Guiseppe; Chiappini, Stefania; Rewhorn, Matthew; Cakir, Omer Onur ; Harvey, Hannah; Castiglione, Fabio; Alnajjar, Hussain; Muneer, Asif; Deho, Frederico; Schifano, Fabrizio; Montorsi, Francesco; Salonia, Andrea .

In: International Journal of Impotence Research, 05.05.2022.

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Schifano, Nicolo ; Cappogrosso, Paolo ; Boeri, Luca ; Fallara, Guiseppe ; Chiappini, Stefania ; Rewhorn, Matthew ; Cakir, Omer Onur ; Harvey, Hannah ; Castiglione, Fabio ; Alnajjar, Hussain ; Muneer, Asif ; Deho, Frederico ; Schifano, Fabrizio ; Montorsi, Francesco ; Salonia, Andrea . / 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. In: International Journal of Impotence Research. 2022.

Bibtex

@article{8157b4d289d7452ab25f5edbdfe6621e,
title = "Are finasteride-related penile curvature/Peyronie{\textquoteright}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",
abstract = "A limited number of studies have described patients on finasteride showing findings which were consistent with Peyronie{\textquoteright}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 10 drugs which were associated the most with the adverse drug reactions (ADRs) recorded as {\textquoteleft}penile curvature{\textquoteright} and/or {\textquoteleft}Peyronie{\textquoteright}s disease{\textquoteright}. 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 9 drugs of the database. Overall, 860 reports of {\textquoteleft}penile curvature{\textquoteright} and/or {\textquoteleft}Peyronie{\textquoteright}s disease{\textquoteright}, 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 {\textquoteleft}serious{\textquoteright} (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 (C.I.95%: 5.6-7.8) and 11.8 (C.I.95%: 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.",
keywords = "finasteride, sexual dysfunction, pharmacovigilance, Peyronie's disease, alopecia",
author = "Nicolo Schifano and Paolo Cappogrosso and Luca Boeri and Guiseppe Fallara and Stefania Chiappini and Matthew Rewhorn and Cakir, {Omer Onur} and Hannah Harvey and Fabio Castiglione and Hussain Alnajjar and Asif Muneer and Frederico Deho and Fabrizio Schifano and Francesco Montorsi and Andrea Salonia",
note = "{\textcopyright} 2022 Springer Nature Limited. This is the accepted manuscript version of an article which has been published in final form at https://doi.org/10.1038/s41443-022-00568-2",
year = "2022",
month = may,
day = "5",
doi = "10.1038/s41443-022-00568-2",
language = "English",
journal = "International Journal of Impotence Research",
issn = "0955-9930",
publisher = "Elsevier",

}

RIS

TY - JOUR

T1 - 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

AU - Schifano, Nicolo

AU - Cappogrosso, Paolo

AU - Boeri, Luca

AU - Fallara, Guiseppe

AU - Chiappini, Stefania

AU - Rewhorn, Matthew

AU - Cakir, Omer Onur

AU - Harvey, Hannah

AU - Castiglione, Fabio

AU - Alnajjar, Hussain

AU - Muneer, Asif

AU - Deho, Frederico

AU - Schifano, Fabrizio

AU - Montorsi, Francesco

AU - Salonia, Andrea

N1 - © 2022 Springer Nature Limited. This is the accepted manuscript version of an article which has been published in final form at https://doi.org/10.1038/s41443-022-00568-2

PY - 2022/5/5

Y1 - 2022/5/5

N2 - 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 10 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 9 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 (C.I.95%: 5.6-7.8) and 11.8 (C.I.95%: 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.

AB - 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 10 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 9 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 (C.I.95%: 5.6-7.8) and 11.8 (C.I.95%: 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.

KW - finasteride

KW - sexual dysfunction

KW - pharmacovigilance

KW - Peyronie's disease

KW - alopecia

U2 - 10.1038/s41443-022-00568-2

DO - 10.1038/s41443-022-00568-2

M3 - Article

JO - International Journal of Impotence Research

JF - International Journal of Impotence Research

SN - 0955-9930

ER -