Pharmacovigilance & drug safety reporting

Al Dweik R, Stacey D, Kohen D, Yaya S. Factors affecting patient reporting of adverse drug reactions: a systematic review. Br J Clin Pharmacol. 2017. doi:10.1111/bcp.13159 • PubMed

Antonazzo IC, Poluzzi E, Forcesi E, et al. Signal of potentially protective drug-drug interactions from spontaneous reporting systems: proceed with caution. Acta Diabetol. 2020. doi:10.1007/s00592-019-01441-3PubMed

Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010. doi:10.1056/NEJMp0911494 • PubMed

Chevance A, Tomlinson A, Ravaud P, et al. Important adverse events to be evaluated in antidepressant trials and meta-analyses in depression: a large international preference study including patients and healthcare professionals. Evid Based Ment Health. Published online: 2022. doi:10.1136/ebmental-2021-300418 • PubMed

[Study in progress as of 2020] European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Suicide and suicidality after exposure to finasteride.

[Preprint] Fusaroli M, Simonsen A, Borrie SA, et al. Identifying medications underlying communication atypicalities in psychotic and affective disorders: a pharmacovigilance study within the FDA Adverse Event Reporting System. medRxiv. Published online 2022. doi:10.1101/2022.09.05.22279609

Gordijn R, Teichert M, Nicolai MPJ, Elzevier HW, Guchelaar HJ. Adverse drug reactions on sexual functioning: a systematic review. Drug Discov Today. 2019 Mar. doi:10.1016/j.drudis.2019.01.012 • PubMed

Gordijn R, Wessels W, Kriek E, et al. Patient reporting of sexual adverse events on an online platform for medication experiences. Br J Clin Pharmacol. 2022 Jul 2. doi:10.1111/bcp.15454 • PubMed

Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006. doi:10.2165/00002018-200629050-00003 • PubMed

Inch J, Watson MC, Anakwe-Umeh S. Patient versus healthcare professional spontaneous adverse drug reaction reporting: a systematic review. Drug Saf. 2012. doi:10.1007/bf03261977 • PubMed

Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA. 2001. doi:10.1001/jama.285.4.437 • PubMed

Krumholz HM, Ross JS, Presler AH, Egilman DS. What have we learnt from Vioxx? BMJ. 2007. doi:10.1136/bmj.39024.487720.68 • PubMed • PMC full text

Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009. doi:10.2165/00002018-200932010-00002 • PubMed

Mayo-Wilson E, Fusco N, Li T, Hong H, Canner JK, Dickersin K; MUDS investigators. Harms are assessed inconsistently and reported inadequately Part 1: systematic adverse events. J Clin Epidemiol. 2019. doi:10.1016/j.jclinepi.2019.04.022PubMed

Mayo-Wilson E, Fusco N, Li T, Hong H, Canner JK, Dickersin K; MUDS investigators. Harms are assessed inconsistently and reported inadequately Part 2: nonsystematic adverse events. J Clin Epidemiol. 2019. doi:10.1016/j.jclinepi.2019.04.020PubMed

Moore TJ. Finasteride and the uncertainties of establishing harms. JAMA Dermatol. 2015 Jun. doi:10.1001/jamadermatol.2015.37 • PubMed

Nizzi MC. Should we trust patient-reported outcomes? AJOB Neurosci. 2021 Apr-Sep. doi:10.1080/21507740.2021.1904040 • PubMed

[Audio interview] Re: adverse event reporting in clinical trials of finasteride for alopecia: Interview with SM Belknap and TJ Moore published by JAMA Dermatol. 2015 Apr 1. Journal site

Seruga B, Templeton AJ, Badillo FE, Ocana A, Amir E, Tannock IF. Under-reporting of harm in clinical trials. Lancet Oncol. 2016 May. doi:10.1016/S1470-2045(16)00152-2 • PubMed

Valeiro C, Matos C, Scholl J, van Hunsel F. Drug-induced sexual dysfunction: an analysis of reports to a national pharmacovigilance database. Drug Saf. 2022 Apr 7. doi:10.1007/s40264-022-01174-3 • PubMed

Veitch ZW, Shepshelovich D, Gallagher C, et al. Underreporting of symptomatic adverse events in phase I clinical trials. J Natl Cancer Inst. 2021. doi:10.1093/jnci/djab015 • PubMedPMC full text