Adverse events associated with use of immunoglobulin in pediatric patients reported to the US Food and Drug Administration Adverse Event Reporting System, 2001-2023. [PDF]
Pediatr Allergy ImmunolAbstract Background Immunoglobulin products are widely used for the treatment of immunodeficiency and autoimmune disorders. Although clinical trials have demonstrated their efficacy and tolerability, data describing their postmarketing safety profile in pediatric populations remain limited, particularly regarding rare and serious adverse events.
Wei S +4 more
europepmc +2 more sources
Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]
, 2014 A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core +3 more sources
Age-Dependent Differences in Canakinumab Safety: A Comprehensive Pharmacovigilance Analysis Using the FAERS Database. [PDF]
Pharmacol Res PerspectABSTRACT While the efficacy of canakinumab, an anti‐interleukin‐1β monoclonal antibody, is well‐established, its safety profile, particularly across different age groups, remains inadequately explored. Using the FDA Adverse Event Reporting System (FAERS) database, this study evaluated postmarketing safety by analyzing adverse event (AE) reports from ...
Wang Y, Lam N, Huang X, Jiao Y.
europepmc +2 more sources
The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication. [PDF]
, 2016 PurposeTo explore whether privacy restrictions developed to protect patients have complicated research within a 15-year surveillance study conducted with US cancer registries.MethodsData from enrolling 27 cancer registries over a 10-year period were ...
Andrews, Elizabeth B +6 more
core +1 more source
Safety profile of oxcarbazepine: results from a prescription-event monitoring study [PDF]
, 2010 Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM.
Buggy, Y. +3 more
core +1 more source
Therapeutic Advances in Drug Safety, 2019 Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product.
Nikhil Raj +5 more
doaj +1 more source
Trends and characteristics of accidental and intentional codeine overdose deaths in Australia [PDF]
, 2015 Examines trends in codeine-related mortality rates in Australia, and the clinical and toxicological characteristics of codeine-related deaths. Abstract Objectives: To examine trends in codeine-related mortality rates in Australia, and the clinical and ...
Amanda Roxburgh +6 more
core +1 more source
Development, Production, and Postmarketing Surveillance of Hepatitis A Vaccines in China
Journal of Epidemiology, 2014 China has long experience using live attenuated and inactivated vaccines against hepatitis A virus (HAV) infection. We summarize this experience and provide recent data on adverse events after immunization (AEFIs) with hepatitis A vaccines in China.
Cui, Fuqiang +5 more
openaire +3 more sources
Neonatal Safety Information Reported to the FDA During Drug Development Studies. [PDF]
, 2018 BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates
Ariagno, Ron +8 more
core +3 more sources