Results 131 to 140 of about 51,036 (300)

Maternal and Neonatal Complications Associated with Breast Cancer Systemic Treatments—A VigiBase Disproportionality Analysis Study

Clinical Pharmacology &Therapeutics, EarlyView.
Pregnancy‐associated breast cancer (PrBC) presents therapeutic challenges. Understanding maternal–fetal safety of systemic anticancer therapies is critical. We performed a case/non‐case disproportionality analysis using the WHO global pharmacovigilance database up to January 2024, to evaluate maternal–fetal outcomes associated with breast cancer (BC ...
Rayan Kabirian, Floriane Jochum, Elise Dumas, Florence Coussy, Kevin Bihan, Bénédicte Lebrun‐Vignes, Barbara Pistilli, Marc‐Antoine Benderra, Lise Selleret, Laurent Chouchana, Fabien Reyal, Anne‐Sophie Hamy, Paul Gougis   +12 more
wiley   +1 more source

A systematic review and pharmacovigilance analysis of the risk of agranulocytosis associated with metamizole use

Scientific Reports
Metamizole is an analgesic widely used after its introduction but later withdrawn in several countries due to the risk of agranulocytosis. Despite this, it remains frequently used worldwide.
Alessia Zinzi, Mario Gaio, Donatella Ruggiero, Consiglia Riccardi, Cecilia Cagnotta, Ciro Pentella, Annalisa Capuano, Concetta Rafaniello   +7 more
doaj   +1 more source

Intelligent Automation Improved Efficiency in Pharmacovigilance Safety Signal Assessment

Clinical Pharmacology &Therapeutics, EarlyView.
Pharmacovigilance is the science involving the detection, assessment, understanding, and prevention of adverse events associated with drugs, biologics, or medical devices. In pharmacovigilance, information that suggests a new potential causal relationship between an intervention and an adverse event is called a safety signal. Following their detection,
Jeffrey Warner, Luis Henrique De Souza Teodoro, Anaclara Prada Jardim, Claudia Albera   +3 more
wiley   +1 more source

Spotlight commentary: Drug therapy in hypoxic environments: From aerospace models to high‐altitude clinical pharmacology

British Journal of Clinical Pharmacology, EarlyView.
Martin Bobek, Jakov Kožić, Feđa Džubur   +2 more
wiley   +1 more source

Maternal Dipyrone Exposure and Risk of Major Congenital Malformations, Adverse Perinatal and Postnatal Outcomes: A Population‐Based Cohort Study

Clinical Pharmacology &Therapeutics, EarlyView.
Pain and fever are common in pregnancy. Dipyrone is widely used in Europe, Latin America, and parts of Asia, but is banned in other countries due to concerns about agranulocytosis. Evidence on its safety in pregnancy remains limited and inconsistent. This study aimed to evaluate whether maternal dipyrone use during the first‐ and third‐trimesters is ...
Itamar Ben Shitrit, Daphna Idan, Ariel Avraham Hasidim, Tal Michael, Amalia Levy, Gali Pariente, Eitan Lunenfeld, Sharon Daniel   +7 more
wiley   +1 more source

Frequency, Timing, Burden and Recurrence of Adverse Events Following Immunization After HPV Vaccine Based on a Cohort Event Monitoring Study in the Netherlands

Vaccines
Background/Objectives: The aim of this study was to systematically assess Adverse Events Following Immunization (AEFI) among children following administration of the human papillomavirus (HPV) vaccine (Cervarix®) included in the Dutch National ...
Monika Raethke, Jeroen Gorter, Rachel Kalf, Leontine van Balveren, Rana Jajou, Florence van Hunsel   +5 more
doaj   +1 more source

Medication literacy among community-dwelling older adults in Shenzhen: a 2024 cross-sectional survey with psychometric evidence

Frontiers in Public Health
ObjectiveTo provide a scientific basis for policymakers and healthcare providers in developing targeted interventions, we investigated the level of medication literacy and its contributing factors among the older population in Shenzhen.MethodsA cross ...
Fenfang Wei, Menghuan Yang, Xiaoyu Liu, Qian Wang, Jianru Wu, Qianhe Jian, Wenyu Wu, Mengdan Xu, Mengdan Xu   +8 more
doaj   +1 more source

PHARMACOVIGILANCE: AREAS TO REFORM

, 2012
Pharmacovigilance is growing in India. Given the size of the pharmaceutical market in India, it is important to understand how pharmacovigilance impacts the pharmaceutical products.
Surya Chandra. D, Akram Ahmad*, Isha Patel1, Krishna kanth.T, G.P. Mohanta, Parimalakrishnan. S
core   +1 more source

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

Longitudinal Cohort Event Monitoring of MMR and DT-IPV Vaccination at 9 Years of Age in The Netherlands

Pharmaceuticals
Background/Objectives: The Dutch National Immunisation Programme (NIP) aims to protect children against severe infectious diseases. As with all vaccines, adverse events following immunisation (AEFIs) may occur with the use of vaccines in the NIP.
Monika Raethke, Jeroen Gorter, Rachel Kalf, Leontine van Balveren, Sanne Boetzkes, Rana Jajou, Florence van Hunsel   +6 more
doaj   +1 more source