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Birth defects reporting and the use of dydrogesterone: a disproportionality analysis from the World Health Organization pharmacovigilance database (VigiBase).
Hum Reprod Open
January 2025
Regional Center of Pharmacovigilance, Pharmacology Department, Cochin Hospital, AP-HP.Centre-Université Paris Cité, Paris, France.
Study Question: Is there an association between dydrogesterone exposure during early pregnancy and the reporting of birth defects?
Summary Answer: This observational analysis based on global safety data showed an increased reporting of birth defects, mainly hypospadias and congenital heart defects (CHD), in pregnancies exposed to dydrogesterone, especially when comparing to progesterone.
What Is Known Already: Intravaginal administration of progesterone is the standard of care to overcome luteal phase progesterone deficiency induced by ovarian stimulation in ART. In recent years, randomized controlled clinical trials demonstrated that oral dydrogesterone was non-inferior for pregnancy rate at 12 weeks of gestation and could be an alternative to micronized vaginal progesterone.
Safety assessment of ezetimibe: real-world adverse event analysis from the FAERS database.
Expert Opin Drug Saf
December 2024
Department of Cardiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.
Background: Ezetimibe is known for its lipid-lowering safety and tolerability, but its real-world adverse effects have not been fully evaluated. In this study, adverse events associated with ezetimibe were investigated using the FAERS database for the period 2004 to 2023.
Research Design And Methods: Adverse events data for ezetimibe, spanning from the first quarter of 2004 to the fourth quarter of 2023, were standardized and analyzed using signal quantification methods like Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (EBGM).
The quantity, reliability, transparency, reporting, and interpretation of pharmacovigilance signal detection studies in pregnancy: a meta-epidemiological study.
Eur J Clin Pharmacol
February 2025
Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Children's Medicine Key Laboratory of Sichuan Province, Renmin Nan Road 20, Chengdu, 610041, China.
Purpose: To systematically review the characteristics of the available pharmacovigilance signal detection studies in pregnancy, and comprehensively assess the reliability, transparency, reporting, and interpretation of these studies.
Methods: We searched five databases from inception to February 2024 to identify the available pharmacovigilance signal detection studies in pregnancy. We extracted three aspects of information (basic information, data processing modes, signal detection analyses) to assess the reliability, transparency, and reporting of each study.
Pregnancy and Infant Outcomes in Women With Multiple Sclerosis Treated With Ocrelizumab.
Neurol Neuroimmunol Neuroinflamm
January 2025
Katholisches Klinikum Bochum, St. Josef Hospital, Bochum, Germany.
Background And Objectives: Ocrelizumab labeling advises contraception for women during treatment and for 6-12 months thereafter. Because pregnancies may occur during this time, it is critical to understand pregnancy and infant outcomes in women with multiple sclerosis (MS) after ocrelizumab exposure.
Methods: Pregnancy cases reported to Roche global pharmacovigilance until 12 July 2023 were analyzed.
Reproductive Toxicity Induced by Serotonin-Norepinephrine Reuptake Inhibitors: A Pharmacovigilance Analysis From 2004 to 2023 Based on the FAERS Database.
CNS Neurosci Ther
December 2024
Department of Urology, Second Hospital of Shanxi Medical University, Taiyuan, China.
Aim: Serotonin-norepinephrine reuptake inhibitors (SNRIs) have been extensively utilized for the treatment of depression and anxiety disorders. Clinical trials and real-world data suggest that SNRIs may cause reproductive toxicity. To comprehensively assess this association, we conducted a pharmacovigilance study.
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