PMID- 37847653 OWN - NLM STAT- MEDLINE DCOM- 20231225 LR - 20240314 IS - 1527-974X (Electronic) IS - 1067-5027 (Print) IS - 1067-5027 (Linking) VI - 31 IP - 1 DP - 2023 Dec 22 TI - Using natural language processing to characterize and predict homeopathic product-associated adverse events in consumer reviews: comparison to reports to FDA Adverse Event Reporting System (FAERS). PG - 70-78 LID - 10.1093/jamia/ocad197 [doi] AB - OBJECTIVE: Apply natural language processing (NLP) to Amazon consumer reviews to identify adverse events (AEs) associated with unapproved over the counter (OTC) homeopathic drugs and compare findings with reports to the US Food and Drug Administration Adverse Event Reporting System (FAERS). MATERIALS AND METHODS: Data were extracted from publicly available Amazon reviews and analyzed using JMP 16 Pro Text Explorer. Topic modeling identified themes. Sentiment analysis (SA) explored consumer perceptions. A machine learning model optimized prediction of AEs in reviews. Reports for the same time interval and product class were obtained from the FAERS public dashboard and analyzed. RESULTS: Homeopathic cough/cold products were the largest category common to both data sources (Amazon = 616, FAERS = 445) and were analyzed further. Oral symptoms and unpleasant taste were described in both datasets. Amazon reviews describing an AE had lower Amazon ratings (X2 = 224.28, P < .0001). The optimal model for predicting AEs was Neural Boosted 5-fold combining topic modeling and Amazon ratings as predictors (mean AUC = 0.927). DISCUSSION: Topic modeling and SA of Amazon reviews provided information about consumers' perceptions and opinions of homeopathic OTC cough and cold products. Amazon ratings appear to be a good indicator of the presence or absence of AEs, and identified events were similar to FAERS. CONCLUSION: Amazon reviews may complement traditional data sources to identify AEs associated with unapproved OTC homeopathic products. This study is the first to use NLP in this context and lays the groundwork for future larger scale efforts. CI - Published by Oxford University Press on behalf of the American Medical Informatics Association 2023. FAU - Konkel, Karen AU - Konkel K AUID- ORCID: 0000-0001-6129-9120 AD - Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, United States. AD - Department of Health Services Administration, School of Health Professions, The University of Alabama at Birmingham, Birmingham, AL 35233, United States. FAU - Oner, Nurettin AU - Oner N AUID- ORCID: 0000-0002-4761-7863 AD - Department of Health Services Administration, School of Health Professions, The University of Alabama at Birmingham, Birmingham, AL 35233, United States. FAU - Ahmed, Abdulaziz AU - Ahmed A AUID- ORCID: 0000-0001-6081-8507 AD - Department of Health Services Administration, School of Health Professions, The University of Alabama at Birmingham, Birmingham, AL 35233, United States. FAU - Jones, S Christopher AU - Jones SC AUID- ORCID: 0000-0002-0478-0978 AD - Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, United States. FAU - Berner, Eta S AU - Berner ES AUID- ORCID: 0000-0003-4319-2949 AD - Department of Health Services Administration, School of Health Professions, The University of Alabama at Birmingham, Birmingham, AL 35233, United States. AD - Informatics Institute, The University of Alabama at Birmingham, Birmingham, AL 35294, United States. FAU - Zengul, Ferhat D AU - Zengul FD AUID- ORCID: 0000-0002-8454-1335 AD - Department of Health Services Administration, School of Health Professions, The University of Alabama at Birmingham, Birmingham, AL 35233, United States. AD - Informatics Institute, The University of Alabama at Birmingham, Birmingham, AL 35294, United States. AD - Electrical & Computer Engineering, The Center for Integrated Systems, The University of Alabama at Birmingham, Birmingham, AL 35294, United States. LA - eng PT - Journal Article PL - England TA - J Am Med Inform Assoc JT - Journal of the American Medical Informatics Association : JAMIA JID - 9430800 SB - IM EIN - J Am Med Inform Assoc. 2023 Nov 20;:. PMID: 37986619 MH - United States MH - Humans MH - *Adverse Drug Reaction Reporting Systems MH - Natural Language Processing MH - *Drug-Related Side Effects and Adverse Reactions MH - Software MH - United States Food and Drug Administration MH - Cough PMC - PMC10746310 OTO - NOTNLM OT - OTC drugs OT - adverse drug event OT - consumer preferences OT - drug safety OT - homeopathic remedies OT - natural language processing COIS- None declared. EDAT- 2023/10/17 18:43 MHDA- 2023/12/25 06:42 PMCR- 2024/10/17 CRDT- 2023/10/17 13:13 PHST- 2023/06/27 00:00 [received] PHST- 2023/09/19 00:00 [revised] PHST- 2023/10/10 00:00 [accepted] PHST- 2024/10/17 00:00 [pmc-release] PHST- 2023/12/25 06:42 [medline] PHST- 2023/10/17 18:43 [pubmed] PHST- 2023/10/17 13:13 [entrez] AID - 7320056 [pii] AID - ocad197 [pii] AID - 10.1093/jamia/ocad197 [doi] PST - ppublish SO - J Am Med Inform Assoc. 2023 Dec 22;31(1):70-78. doi: 10.1093/jamia/ocad197.