Results 21 to 30 of about 6,307 (191)

Age‐related differences in hydroxychloroquine‐associated adverse events: A pharmacovigilance study based on the FDA Adverse Event Reporting System

British Journal of Clinical Pharmacology, EarlyView.
Aims This real‐world pharmacovigilance study utilizes FDA Adverse Event Reporting System (FAERS) data (2004–2024) to characterize age‐related disparities in hydroxychloroquine (HCQ)‐associated adverse events (AEs), addressing gaps in age‐stratified risk assessment. Methods Disproportionality analysis (reporting odds ratios, RORs) and parametric Weibull
Guanghan Sun, Jingrong Yang, Lei Wan, Xia Xu, Jing Wang   +4 more
wiley   +1 more source

Complementing the US Food and Drug Administration Adverse Event Reporting System With Adverse Drug Reaction Reporting From Social Media: Comparative Analysis

JMIR Public Health and Surveillance, 2020
BackgroundAdverse drug reactions (ADRs) can occur any time someone uses a medication. ADRs are systematically tracked and cataloged, with varying degrees of success, in order to better understand their etiology and develop methods of prevention.
Zhou, Zeyun, Hultgren, Kyle Emerson
doaj   +1 more source

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad, Anshu Arora, Arun Arora, Jeena Vaid, Arif Khan   +4 more
wiley   +1 more source

Pharmacovigilance evaluation of somatrogon-associated adverse events in real-world databases

Endocrine Connections
Background: Somatrogon, a long-acting recombinant human growth hormone, is used in children with growth hormone deficiency. While clinical trials have shown its safety, real-world post-marketing data are limited, and uncommon or delayed adverse events ...
Mengyuan Cai, Qian Guo, Huqiang Dong, Yabo Wang, Zhongyu Han, Ping Xu   +5 more
doaj   +1 more source

Safety outcomes of antidiabetic medications: A comprehensive review of the EU summaries of product characteristics and international clinical practice guidelines

British Journal of Clinical Pharmacology, EarlyView.
Aims Information on the safety profile of antidiabetic medications is essential for informed treatment decisions in type 2 diabetes mellitus. Although this information is available in regulatory documents of individual drugs, a comprehensive overview across all approved antidiabetics is lacking.
David Liang, Daniala L. Weir, Safana Thevasahayam, Vera H. M. Deneer, Arno Siebes, Helga Gardarsdottir   +5 more
wiley   +1 more source

Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?

Clinical Pharmacology &Therapeutics, EarlyView.
Pediatric drug development has achieved remarkable success in the last 20 years with over 1,000 products studied in pediatric patients. This success has been driven in part by an increased understanding of pediatric disease processes. The aspect that has been largely overlooked is the potential adverse effect of new drugs on pediatric developmental ...
Gilbert J. Burckart, Susan M. Abdel‐Rahman, Gelareh Abulwerdi, Sherbet Samuels, Rebecca Racz, Mohamed A. Mohamoud, Nicholas P. Tatonetti   +6 more
wiley   +1 more source

Assessment of the Safety Signal for the Abuse Potential of Pregabalin and Gabapentin Using the FAERS Database and Big Data Search Analytics

Frontiers in Psychiatry, 2021
Introduction: The latest decade, an emerging issue has been the abuse potential of the gabapentinoids pregabalin and gabapentin. The aim of our study was to assess this safety signal combining two different methods of surveillance: search analytics big ...
Georgios Papazisis, Dimitrios Spachos, Spyridon Siafis, Niki Pandria, Eleni Deligianni, Ioannis Tsakiridis, Antonios Goulas   +6 more
doaj   +1 more source

Adverse Reactions Identified after Approval of Novel Medicines: Analysis of 339 New Molecular Entities and Therapeutic Biologics

Clinical Pharmacology &Therapeutics, EarlyView.
Postmarketing safety surveillance data identify safety issues not identified in preapproval clinical trials. We describe the frequency of new safety issues overall and by labeling section and the relationship of the most commonly added safety issues with the cumulative number of prescriptions dispensed via retail pharmacies.
Ellen Pinnow, Brendan Day, Esther H. Zhou, Corinne Woods, Nana Dwumfour, Jenni Y. Lee, Ilynn Bulatao, Sanae Cherkaoui, Manish Kalaria, Sonja Brajovic, Nabila Sadiq, Farideh Sistani, Maggie Lee, Grace Chai, Gerald Dal Pan   +14 more
wiley   +1 more source

Real-world pharmacovigilance study of drug-induced diabetes insipidus from the FAERS database

Endocrine Connections
Objective: This study aims to identify potential drugs associated with diabetes insipidus (DI) and track its epidemiological characteristics using the FDA Adverse Event Reporting System (FAERS) database.
Hui Lv, Yue Wu, Lan Lan, Nonger Shen
doaj   +1 more source

Association of Glucagon‐Like Peptide—1 Receptor Analogues and Laryngeal Symptoms in Obese Adults

The Laryngoscope, EarlyView.
Table 1 succinctly quantifies the time‑dependent association between GLP‑1RA/GIP therapy and laryngeal symptoms, demonstrating modest but statistically robust increases in outcomes such as cough and voice/resonance disorders by 6 months. It provides clinically actionable absolute risks, odds ratios, and hazard ratios that can directly inform counseling,
Priyanka Shah, David Kayekjian, Shaun A. Nguyen, Kirsten Meenan, Ashli K. O’Rourke   +4 more
wiley   +1 more source