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

Costa C, Abeijon P, Rodrigues DA, Figueiras A, Herdeiro MT, Torre C. Factors associated with underreporting of adverse drug reactions by patients: a systematic review. Int J Clin Pharm. 2023. doi:10.1007/s11096-023-01592-y • PubMed • PMC full text

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

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. J Speech Lang Hear Res. 2023. doi:10.1044/2023_JSLHR-22-00739 • PubMed

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

Montastruc JL. Drug-induced diseases: A worrying, neglected, preventable, serious and costly epidemic. Therapie. 2023. doi:10.1016/j.therap.2023.10.007 • PubMed

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