Medications mostly associated with priapism events: assessment of the 2015-2020 Food and Drug Administration (FDA) pharmacovigilance database entries.


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:
21 May 2022
Historique:
received: 24 10 2021
accepted: 03 05 2022
revised: 25 04 2022
pubmed: 22 5 2022
medline: 22 5 2022
entrez: 21 5 2022
Statut: aheadofprint

Résumé

A range of drugs have a direct role in triggering ischaemic priapism. We aimed at identifying: a) which medications are associated with most priapism-reports; and, b) within these medications, comparing their potential to elicit priapism through a disproportionality analysis. The FDA Adverse Event Reporting System (FAERS) database was queried to identify those drugs associated the most with priapism reports over the last 5 years. Only those drugs being associated with a minimum of 30 priapism reports were considered. The Proportional Reporting Ratios (PRRs), and their 95% confidence intervals were computed. Out of the whole 2015-2020 database, 1233 priapism reports were identified, 933 of which (75.7%) were associated with 11 medications with a minimum of 30 priapism-reports each. Trazodone, olanzapine and tadalafil showed levels of disproportionate reporting, with a PRR of 9.04 (CI95%: 7.73-10.58), 1.55 (CI95%: 1.27-1.89), and 1.42 (CI95%: 1.10-1.43), respectively. Most (57.5%) of the reports associated with the phosphodiesterase type 5 inhibitors (PDE5Is) were related with concomitant priapism-eliciting drugs taken at the same time and/or inappropriate intake/excessive dosage. Patients taking trazodone and/or antipsychotics need to be aware of the priapism-risk; awareness among prescribers would help in reducing priapism-related detrimental sequelae; PDE5I-intake is not responsible for priapism by itself, when appropriate medical supervision is provided.

Identifiants

pubmed: 35597798
doi: 10.1038/s41443-022-00583-3
pii: 10.1038/s41443-022-00583-3
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2022. The Author(s), under exclusive licence to Springer Nature Limited.

Références

Salonia A, Eardley I, Giuliano F, Hatzichristou D, Moncada I, Vardi Y, et al. European association of urology guidelines on priapism. Eur Urol. 2014;65:480–9. https://doi.org/10.1016/j.eururo.2013.11.008
doi: 10.1016/j.eururo.2013.11.008 pubmed: 24314827
Salonia A, Bettocchi C, Boeri L, Capogrosso P, Carvalho J, Cilesiz NC, et al. EAU Working Group on Male Sexual and Reproductive Health. European Association of Urology Guidelines on Sexual and Reproductive Health-2021 Update: Male Sexual Dysfunction. Eur Urol. 2021;80:333–57.
Arrichiello A, Angileri SA, Buccimazza G, Di Bartolomeo F, Di Meglio L, Liguori A, et al. Interventional radiology management of high flow priapism: review of the literature. Acta Biomed. 2020;91:e2020010 https://doi.org/10.23750/abm.v91i10-S.10233
doi: 10.23750/abm.v91i10-S.10233 pubmed: 33245065 pmcid: 8023077
Zacharakis E, Garaffa G, Raheem AA, Christopher AN, Muneer A, Ralph DJ. Penile prosthesis insertion in patients with refractory ischaemic priapism: early vs delayed implantation. BJU Int. 2014;114:576–81. https://doi.org/10.1111/bju.12686
doi: 10.1111/bju.12686 pubmed: 25383397
Eland IA, Van der Lei J, Stricker BHC, Sturkenboom MJCM. Incidence of priapism in the general population. Urology. 2001;57:970–2. https://doi.org/10.1016/S0090-4295(01)00941-4
doi: 10.1016/S0090-4295(01)00941-4 pubmed: 11337305
Hwang T, Shah T, Sadeghi-Nejad H. A review of antipsychotics and priapism. Sex Med Rev. 2021;9:464–71. https://doi.org/10.1016/j.sxmr.2020.10.003
doi: 10.1016/j.sxmr.2020.10.003 pubmed: 33214060
Rubin R. Use of illicit drugs continues to rise. JAMA. 2019;322:1543 https://jamanetwork.com/journals/jama/article-abstract/2753347 accessed 18 Aug 2021
pubmed: 31638661
Zhao H, Berdahl C, Bresee C, Moradzadeh A, Houman J, Kim H, et al. Priapism from recreational intracavernosal injections in a high-risk metropolitan community. J Sex Med. 2019;16:1650–4. https://doi.org/10.1016/j.jsxm.2019.07.024
doi: 10.1016/j.jsxm.2019.07.024 pubmed: 31501058 pmcid: 7416696
Montastruc JL, Sommet A, Bagheri H, Lapeyre-Mestre M. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol. 2011. https://doi.org/10.1111/j.1365-2125.2011.04037.x .
Kumar A. The newly available FAERS public dashboard: implications for health care professionals. Hosp Pharm. 2019;54:75–7. https://doi.org/10.1177/0018578718795271
doi: 10.1177/0018578718795271 pubmed: 30923396
EMA. Guideline on good pharmacovigilance practices (GVP) Annex I—Definitions (Rev 4). Heads Med Agencies. 2017.
Schifano N, Chiappini S, Castiglione F, Salonia A, Schifano F. Is medicinal ketamine associated with urinary dysfunction issues? Assessment of both the European Medicines Agency (EMA) and the UK Yellow Card Scheme pharmacovigilance database-related reports. Low Urin Tract Symptoms. 2020.
Chiappini S, Schifano F. A decade of gabapentinoid misuse: an analysis of the European Medicines Agency’s ‘suspected adverse drug reactions’ database. CNS Drugs. 2016;30:647–54. https://doi.org/10.1007/s40263-016-0359-y
doi: 10.1007/s40263-016-0359-y pubmed: 27312320
European Medicines Agency. Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system. 2008.
WHO. The WHO Programme for International Drug Monitoring. 2015.
Felicetti P, Trotta F, Bonetto C, Santuccio C, Brauchli Pernus Y, Burgner D, et al. Spontaneous reports of vasculitis as an adverse event following immunization: a descriptive analysis across three international databases. Vaccine. 2016. https://doi.org/10.1016/j.vaccine.2015.09.027 .
Scherzer ND, Reddy AG, Le TV, Chernobylsky D, Hellstrom WJG. Unintended consequences: a review of pharmacologically-induced priapism. Sex Med Rev. 2019;7:283–92. https://doi.org/10.1016/j.sxmr.2018.09.002
doi: 10.1016/j.sxmr.2018.09.002 pubmed: 30503727
Grundmark B, Holmberg L, Garmo H, Zethelius B. Reducing the noise in signal detection of adverse drug reactions by standardizing the background: a pilot study on analyses of proportional reporting ratios-by-therapeutic area. Eur J Clin Pharm. 2014. https://doi.org/10.1007/s00228-014-1658-1
doi: 10.1007/s00228-014-1658-1
Dutta R, Matz EL, Overholt TL, Anderson WB, Deebel NA, Cowper M, et al. Patient education is associated with reduced delay to presentation for management of ischemic priapism: a retrospective review of 123 men. J Sex Med. 2021;18:385–90. https://doi.org/10.1016/j.jsxm.2020.11.017
doi: 10.1016/j.jsxm.2020.11.017 pubmed: 33422447
Shah T, Deolanker J, Luu T, Sadeghi-Nejad H. Pretreatment screening and counseling on prolonged erections for patients prescribed trazodone. Investig Clin Urol. 2021;62:85–9. https://doi.org/10.4111/icu.20200195
doi: 10.4111/icu.20200195 pubmed: 33314808
Matz A, Ambinder D, Spencer E, Phillips J, Wong NC. Review of priapism litigation in the United States. Urology. 2021. https://doi.org/10.1016/j.urology.2021.05.001 .
Panchatsharam PK, Durland J, Zito PM. Physiology, erection. physiol erection [Updated 9 May 2021] 2021: In: StatPearls [Internet]. Treasure Island (FL). https://www.ncbi.nlm.nih.gov/books/NBK513278/ (accessed 18 Aug 2021).
Traish A, Kim NN, Moreland RB, Goldstein I. Role of alpha adrenergic receptors in erectile function. Int J Impot Res. 2000;12:S48–63. https://doi.org/10.1038/sj.ijir.3900506
doi: 10.1038/sj.ijir.3900506 pubmed: 10845765
Greiner T, Schneider M, Regente J, Toto S, Bleich S, Grohmann R, et al. Priapism induced by various psychotropics: a case series. World J Biol Psychiatry. 2019;20:505–12. https://doi.org/10.1080/15622975.2018.1520396
doi: 10.1080/15622975.2018.1520396 pubmed: 30208753
Dent LA, Brown WC, Murney JD. Citalopram-induced priapism. Pharmacotherapy. 2002;22:538–41.
Trivedi SK, Mangot AG, Sinha S. Aripiprazole-induced priapism n.d.
Koirala S, Penagaluri P, Smith C, Lippmann S. Priapism and risperidone. South Med J. 2009;102:1266–8. https://doi.org/10.1097/SMJ.0b013e3181c04775
doi: 10.1097/SMJ.0b013e3181c04775 pubmed: 20016438
Goldmeier D. Prolonged erections produced by dihydrocodeine and sildenafil. BMJ. 2002;312:44 https://doi.org/10.1136/bmj.312.7022.44
doi: 10.1136/bmj.312.7022.44
Aoyagi T, Hayakawa K, Miyaji K, Ishikawa H, Hata M. Sildenafil induced priapism. Bull Tokyo Dent Coll. 1999;40:215–7. https://doi.org/10.2209/tdcpublication.40.215
doi: 10.2209/tdcpublication.40.215 pubmed: 11933312
Cantrell FL. Sildenafil citrate ingestion in a pediatric patient. Pediatr Emerg Care. 2004;20:314–5. https://doi.org/10.1097/01.pec.0000125660.50937.b5
doi: 10.1097/01.pec.0000125660.50937.b5 pubmed: 15123903
Kumar R, Cantrell FL, Galatti L, Fioravanti A, Salvo F, Polimeni G, et al. Penile fracture after priapism due to sildenafil ingestion: out of frying pan into the fire. J Anal Toxicol. 2015;39:314–5. https://doi.org/10.1182/blood.v95.5.1878
doi: 10.1182/blood.v95.5.1878
Galatti L, Fioravanti A, Salvo F, Polimeni G, Giustini SE. Interaction between tadalafil and itraconazole [4]. Ann Pharmacother. 2005;39:200 https://doi.org/10.1345/aph.1E383
doi: 10.1345/aph.1E383 pubmed: 15572599
Kassim AA, Fabry ME, Nagel RL. Acute priapism associated with the use of sildenafil in a patient with sickle cell trait [3]. Blood. 2000;95:1878–9. https://doi.org/10.1182/blood.v95.5.1878
doi: 10.1182/blood.v95.5.1878 pubmed: 10744389
Matheeussen V, Maudens KE, Anseeuw K, Neels H. A non-fatal self-poisoning attempt with sildenafil. J Anal Toxicol. 2015;39:572–6. https://doi.org/10.1093/jat/bkv071
doi: 10.1093/jat/bkv071 pubmed: 26139313
Sharma D, Kumar M, Pandey S, Agarwal S. Penile fracture after priapism due to sildenafil ingestion: out of frying pan into the fire. BMJ Case Rep. 2018;2018:1–2. https://doi.org/10.1136/bcr-2018-226562
doi: 10.1136/bcr-2018-226562
Khan QS, Tucker P, Lokhande A. Priapism: what cause: mental illness, psychotropic medications or poly-substance abuse? J Okla State Med Assoc. 2016;109:515–7.
pubmed: 29283546
Rezaee ME, Gross MS. Are we overstating the risk of priapism with oral phosphodiesterase type 5 inhibitors? J Sex Med. 2020;17:1579–82. https://doi.org/10.1016/j.jsxm.2020.05.019
doi: 10.1016/j.jsxm.2020.05.019 pubmed: 32622767
McLeod AL, McKenna CJ, Northridge DB. Myocardial infarction following the combined recreational use of Viagra and cannabis. Clin Cardiol. 2002;25:133–4. https://doi.org/10.1002/clc.4960250310
doi: 10.1002/clc.4960250310 pubmed: 11890373
Bechara A, Casabé A, De Bonis W, Helien A, Bertolino MV. Recreational use of phosphodiesterase type 5 inhibitors by healthy young men. J Sex Med. 2010;7:3736–42. https://doi.org/10.1111/j.1743-6109.2010.01965.x
doi: 10.1111/j.1743-6109.2010.01965.x pubmed: 20722788
Gebreyohannes EA, Bhagavathula AS, Gebresillassie BM, Tefera YG, Belachew SA, Erku DA. Recreational use of phosphodiesterase 5 inhibitors and its associated factors among undergraduate male students in an Ethiopian University: a cross-sectional study. World J Mens Health. 2016;34:186–93. https://doi.org/10.5534/wjmh.2016.34.3.186
doi: 10.5534/wjmh.2016.34.3.186 pubmed: 28053948 pmcid: 5209559

Auteurs

Nicolò Schifano (N)

Università Vita-Salute San Raffaele, Milan, Italy.
Division of Experimental Oncology/Unit of Urology, URI; IRCCS Ospedale San Raffaele, Milan, Italy.

Paolo Capogrosso (P)

ASST Sette Laghi-Circolo e Fondazione Macchi Hospital, Varese, Italy.

Luca Boeri (L)

Division of Experimental Oncology/Unit of Urology, URI; IRCCS Ospedale San Raffaele, Milan, Italy.
Department of Urology, IRCCS Foundation Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.

Giuseppe Fallara (G)

Università Vita-Salute San Raffaele, Milan, Italy.
Division of Experimental Oncology/Unit of Urology, URI; IRCCS Ospedale San Raffaele, Milan, Italy.

Omer Onur Cakir (OO)

Institute of Andrology, Department of Urology, University College London Hospitals NHS Trust, London, UK.
Division of Surgery and Interventional Science, UCL, London, UK.

Fabio Castiglione (F)

Institute of Andrology, Department of Urology, University College London Hospitals NHS Trust, London, UK.
Division of Surgery and Interventional Science, UCL, London, UK.

Hussain M Alnajjar (HM)

Institute of Andrology, Department of Urology, University College London Hospitals NHS Trust, London, UK.
Division of Surgery and Interventional Science, UCL, London, UK.

Asif Muneer (A)

Institute of Andrology, Department of Urology, University College London Hospitals NHS Trust, London, UK.
Division of Surgery and Interventional Science, UCL, London, UK.

Federico Deho' (F)

ASST Sette Laghi-Circolo e Fondazione Macchi Hospital, Varese, Italy.

Fabrizio Schifano (F)

Psychopharmacology; Drug Misuse; and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, UK.

Francesco Montorsi (F)

Università Vita-Salute San Raffaele, Milan, Italy.
Division of Experimental Oncology/Unit of Urology, URI; IRCCS Ospedale San Raffaele, Milan, Italy.

Andrea Salonia (A)

Università Vita-Salute San Raffaele, Milan, Italy. salonia.andrea@hsr.it.
Division of Experimental Oncology/Unit of Urology, URI; IRCCS Ospedale San Raffaele, Milan, Italy. salonia.andrea@hsr.it.

Classifications MeSH