Results 31 to 40 of about 9,302 (232)

Main characteristics of pediatric ICSRs (N = 106,122) within FAERS.

, 2015
Main characteristics of pediatric ICSRs (N = 106,122) within FAERS.
Miriam C. J. M. Sturkenboom (505613), Ian C. K. Wong (306894), Sandra de Bie (757983), Carmen Ferrajolo (605704), Katia M. C. Verhamme (757984), Jan Bonhoeffer (442451), Sabine M. J. M. Straus (391651)   +6 more
core   +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

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

Unsupervised machine learning for multi‐system adverse event pattern detection in pharmacovigilance: A proof‐of‐concept analysis of fluoroquinolone reports in FAERS

British Journal of Clinical Pharmacology, EarlyView.
. Aims Traditional pharmacovigilance detects single drug–event associations but cannot readily characterize multi‐system adverse‐event patterns such as fluoroquinolone‐associated disability. We evaluated unsupervised machine learning for this purpose, using fluoroquinolones as an exemplar.
Niaz Chalabianloo, Sheikh S. Abdullah, Kamran Sedig, Flory T. Muanda   +3 more
wiley   +1 more source

Antidepressant use and Parkinson's disease risk: Overall protective effect with drug‐specific variation [PDF]

Gen Psychiatr
ABSTRACT Background Antidepressants can cause extrapyramidal side effects, but their impact on Parkinson's disease (PD) risk remains unclear. Aims We aimed to investigate the association between genetic liability to antidepressant use and PD. Methods We examined the causal effect of antidepressant use on PD using Mendelian randomisation (MR) analysis ...
Baranova A, Cao H, Xu C, Sun W, Liu D, Zhang F.   +5 more
europepmc   +2 more sources

Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting

Clinical Pharmacology &Therapeutics, EarlyView.
Accurate identification of medicines used in adverse event reports is crucial for effective postmarketing safety surveillance. The US Food and Drug Administration's (FDA) four‐letter suffix naming convention was designed to facilitate accurate biological product identification, but the extent to which these suffixes have been incorporated into ...
Danijela Stojanovic, Lisa Wolf, M. Stacey Ricci, Monica A. Muñoz   +3 more
wiley   +1 more source

Leveraging FAERS and Big Data Analytics with Machine Learning for Advanced Healthcare Solutions [PDF]

, 2022
This research study explores the potential of leveraging the FDA Adverse Event Reporting System (FAERS), combined with big data analytics and machine learning techniques, to enhance healthcare solutions.
Ali, Ahmed Hassan, Saber, Sameh
core  

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

Adapalene‐Associated Cutaneous Adverse Events: A Disproportionality Analysis of the FAERS Database [PDF]

J Cosmet Dermatol
Journal of Cosmetic Dermatology, Volume 25, Issue 10, October 2026.
Cao Z, Zhao C.
europepmc   +2 more sources

A Practical Guide to Implementing Real‐World Evidence as Primary Basis for Approval and Label Expansion

Clinical Pharmacology &Therapeutics, EarlyView.
In June 2026, the FDA issued a revised draft guidance describing the circumstances in which one adequate and well‐controlled clinical investigation plus confirmatory evidence may satisfy the statutory substantial evidence standard for establishing efficacy and safety. Confirmatory evidence includes real‐world evidence (RWE).
Tracy J. Mayne, Maurice A. Brookhart, Nancy A. Dreyer   +2 more
wiley   +1 more source