Article
Public, Environmental & Occupational Health
Krista F. Huybrechts, Martin Kulldorff, Sonia Hernandez-Diaz, Brian T. Bateman, Yanmin Zhu, Helen Mogun, Shirley Wang
Summary: The scientific community relies on postmarketing approaches to assess the risks of medication use during pregnancy, but existing studies often focus on specific outcomes. The study used a new tree-based scan statistic data-mining method, TreeScan, identified known safety concerns, and found only one new risk alert in one of the cases.
AMERICAN JOURNAL OF EPIDEMIOLOGY
(2021)
Article
Pharmacology & Pharmacy
Luiza Hoehl Loureiro Alves Barbosa, Alice Ramos Oliveira Silva, Ana Paula D'Alincourt Carvalho-Assef, Elisangela Costa Lima, Fabricio Alves Barbosa da Silva
Summary: Antibacterial drugs are widely used globally, and it is crucial to assess their risks. This study conducted data mining in the Brazilian database and identified a large number of adverse events related to antibacterials. Important findings include serious side effects of commonly used antibiotics and inadequate or incomplete information in drug labels. These results have important implications for pharmacoepidemiologic research and pharmacovigilance.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Medicine, General & Internal
Tigist Dires Gebreyesus, Eyasu Makonnen, Tafesse Tadele, Habtamu Gashaw, Workagegnew Degefe, Heran Gerba, Birkneh Tilahun Tadesse, Parthasarathi Gurumurthy, Eleni Aklillu
Summary: Preventive chemotherapy with praziquantel and albendazole co-administration is a global strategy to eliminate schistosomiasis and soil-transmitted helminth. This study conducted active safety surveillance to assess the adverse events following the mass drug administration of praziquantel and albendazole in school children. The results showed that the treatment was generally safe, but children infected with parasites were more likely to experience adverse events.
JOURNAL OF CLINICAL MEDICINE
(2022)
Article
Public, Environmental & Occupational Health
Elena Beyzarov, Yan Chen, Rob Julg, Karen Naim, Jigna Shah, William W. Gregory, Ayman Ayoub, Patrick Caubel
Summary: This study analyzed COVID-19 cases reported in individuals receiving treatment with Pfizer pharmaceutical products and cases involving off-label pharmacotherapy for COVID-19. It provided insights into the adverse effects and clinical outcomes associated with the use of various pharmaceutical products in COVID-19 patients.
Article
Multidisciplinary Sciences
Jeong-Eun Lee, Ju Hwan Kim, Ji-Hwan Bae, Inmyung Song, Ju-Young Shin
Summary: This study investigated the utility of supervised machine learning algorithms (GBM and RF) for timely detection of safety signals in the Korea Adverse Event Reporting System. The results demonstrate reliable performance of both algorithms in detecting early safety signals.
SCIENTIFIC REPORTS
(2022)
Article
Medicine, General & Internal
Yujeong Kim, Jong-Hwan Jang, Namgi Park, Na-Young Jeong, Eunsun Lim, Soyun Kim, Nam-Kyong Choi, Dukyong Yoon
Summary: The study developed a machine learning-based active surveillance system for detecting possible factors that can induce adverse events using health claim and vaccination databases. The system successfully predicted health outcomes of interest with high accuracy, contributing to the establishment of a system for conducting active surveillance on vaccination.
JOURNAL OF KOREAN MEDICAL SCIENCE
(2021)
Article
Immunology
Marco Montalti, Zeno Di Valerio, Raffaella Angelini, Elena Bovolenta, Federica Castellazzi, Marta Cleva, Paolo Pandolfi, Chiara Reali, Davide Resi, Renato Todeschini, Davide Gori
Summary: In August 2022, Italy launched a vaccination campaign targeting the spread of monkeypox virus, prioritizing laboratory personnel and men who have sex with men. The study conducted in Bologna and Forlì involved participant-based active surveillance to investigate adverse events following immunization (AEFIs). The findings suggest that the monkeypox vaccine has a high tolerance for short-term systemic AEFIs, but warns about the high incidence and severity of local AEFIs which need to be monitored following intradermal administration of the vaccine.
Review
Pharmacology & Pharmacy
Mia Aakjaer, Marie Louise De Bruin, Morten Andersen
Summary: This study aims to explore methods for sequential analysis of electronic healthcare data to address the limitations of spontaneous reporting systems. Through literature review and experimentation, it has been demonstrated that the use of sequential analysis can successfully conduct epidemiological surveillance of various exposures and outcomes. However, there is a relative lack of research on analyzing data at multiple time points in realistic settings.
BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY
(2023)
Article
Pharmacology & Pharmacy
Eva Montane, Javier Santesmases
Summary: This study describes the characteristics of safety alerts issued by the Spanish Medicines Agency over a 7-year period and the regulatory actions they generated. The results showed that a total of 126 safety alerts were issued during this period, with 92 alerts reporting 147 adverse drug reactions (ADRs) involving 84 drugs. The study highlights the importance of spontaneous reporting of ADRs and the need to assess safety throughout the lifecycle of medicines.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Multidisciplinary Sciences
Hanna Y. Ehrlich, Amy K. Bei, Daniel M. Weinberger, Joshua L. Warren, Sunil Parikh
Summary: Resistance to artemisinin-based combination therapies (ACTs) poses a threat to global malaria control, with persistent circulation of parasite alleles associated with reduced partner drug susceptibility contributing to clinical resistance. Rainfall seasonality was identified as the strongest predictor of wild-type genotype prevalence, with other covariates showing weaker associations. Our models estimated a decrease in prevalence of the pfcrt 76T mutation in 90% of regions.
PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA
(2021)
Article
Pharmacology & Pharmacy
Ji-Hwan Bae, Yeon-Hee Baek, Jeong-Eun Lee, Inmyung Song, Jee-Hyong Lee, Ju-Young Shin
Summary: This study evaluated the feasibility of machine learning algorithms in detecting ADR signals of nivolumab and docetaxel, and found that GBM outperformed traditional methods in detecting new ADR signals.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Public, Environmental & Occupational Health
Jennifer C. Nelson, Ernesto Ulloa-Perez, Onchee Yu, Andrea J. Cook, Michael L. Jackson, Edward A. Belongia, Matthew F. Daley, Rafael Harpaz, Elyse O. Kharbanda, Nicola P. Klein, Allison L. Naleway, Hung-Fu Tseng, Eric S. Weintraub, Jonathan Duffy, W. Katherine Yih, Lisa A. Jackson
Summary: In this study, researchers conducted a post-licensure vaccine safety study on the recombinant zoster vaccine (RZV) and found no sustained increased risk of any prespecified health outcomes for RZV recipients. The study provides additional reassurance about the overall safety of RZV, although there remains uncertainty regarding potential associations with Guillain-Barre syndrome (GBS) due to the limited number of confirmed cases observed.
AMERICAN JOURNAL OF EPIDEMIOLOGY
(2023)
Article
Pharmacology & Pharmacy
Weixin Xie, Limei Wang, Qi Cheng, Xueying Wang, Ying Wang, Hongyuan Bi, Bo He, Weixing Feng
Summary: This study investigated how active learning (AL) could improve machine learning (ML) performance in clinical safety drug-drug interaction (DDI) information retrieval (IR) analysis. By introducing random negative sampling and utilizing two ML algorithms, improvements in precision were achieved in differentiating positive samples from negative samples, as well as random negative samples. The utilization of AL with support vector machine (SVM) and logistic regression (LR) showed promising results in enhancing the precision in DDI IR analysis.
FRONTIERS IN PHARMACOLOGY
(2021)
Review
Pharmacology & Pharmacy
Taxiarchis Botsis, Kory Kreimeyer
Summary: Pharmacovigilance involves monitoring and aggregating adverse event information from various sources, but the most relevant details are often in narrative free-text formats. Natural language processing techniques can be used to extract clinically relevant information from pharmacovigilance texts to inform decision-making.
EXPERT OPINION ON DRUG SAFETY
(2023)
Article
Food Science & Technology
Vincenzo Pennone, Jose F. Cobo-Diaz, Miguel Prieto, Avelino Alvarez-Ordonez
Summary: Recent advancements in genomics and metagenomics have enabled the rapid detection and detailed characterization of antimicrobial resistant microorganisms and resistance genes in the food chain. This review article summarizes the progress made in recent years and discusses the future prospects in this field.
CURRENT OPINION IN FOOD SCIENCE
(2022)