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Drug Development.
Alzheimers Dement
December 2024
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Background: The ability to monitor cognitive trajectories over the course of trials can provide valuable insights into treatment efficacy. However, existing trial methods are limited in monitoring cognition in real-time and at high frequencies. Gameplay-based assessments hold promise as complementary cognitive tools.
View Article and Find Full Text PDFPharmacovigilance study of the association between progestogen and depression based on the FDA adverse event reporting System (FAERS).
Sci Rep
January 2025
Department of pharmacy, Heze University, Heze, 274000, Shandong Province, China.
Progestogens commonly used in the clinic include levonorgestrel, etonogestrel, medroxyprogesterone, hydroxyprogesterone, progesterone, desogestrel, and megestrol. Progestogens are widely used for contraception and the treatment of endometriosis, threatened abortion and other diseases. However, the correlation between progestogen use and depression is not clear.
View Article and Find Full Text PDFUse of Causal Framework to Evaluate Effect of Abuse Deterrent Properties of Extended-Release Oxycodone on Tampering in a Real-World Settings.
Pharmacoepidemiol Drug Saf
January 2025
Rocky Mountain Poison & Drug Safety, Denver Health & Hospital Authority, Denver, Colorado, USA.
Purpose: To assess whether exposure to an extended-release (ER) oxycodone with abuse deterrent properties (ADF) reduced tampering of oxycodone in a real-world, postmarket setting to address the thinking behind Category 4 labeling by the FDA.
Methods: Data from an observational cross-sectional study of the general adult population (2022) was used under a causal framework to estimate the confounding-adjusted odds of tampering oxycodone after exposure to two types of ADF ER oxycodone. The tampering behaviors of those who used only single entity immediate-release (SE-IR) oxycodone was used as a comparison.
A Real-World Pharmacovigilance Study of FDA Adverse Event Reporting System Events for Obeticholic Acid.
Pharmacoepidemiol Drug Saf
January 2025
Hunan Institute for Drug Control, Changsha, Hunan, China.
Background And Objectives: Based on the Adverse Event Reporting System (FAERS) data from the US FDA, this study mined the adverse drug reactions of obeticholic acid (OCA) in the real world and provided reference for clinical safe drug use.
Methods: Adverse event reports for OCA from the second quarter of 2016 to the third quarter of 2023 were extracted. The analysis for adverse reaction signal detection was conducted using reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods.
Medication Hazards and Outcome Patterns of Pediatric Drug-Associated Liver Injury in Taiwan: An Analysis of 1998-2017 Spontaneous Adverse Drug Reaction Reports.
Drugs Real World Outcomes
January 2025
School of Pharmacy, College of Medicine, National Taiwan University, Taipei, 100025, Taiwan.
Background And Objectives: Accumulating pediatric efficacy and safety data on drug use is inherently challenging yet essential. This study aimed to analyze the frequency and compute the odds of pediatric drug-associated liver injury across age groups (early childhood, middle childhood, and adolescence) and therapeutic categories using adverse drug reactions (ADRs) reporting data spanning nearly two decades.
Methods: We analyzed the reports of suspected ADRs occurring in children and adolescents in the Taiwan National Adverse Drug Reaction Reporting System during the period from May 1998 until July 2017.
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