Honglong Wu,Xuchen Fan,Sheng Wu et al. Honglong Wu et al.

Background: Gemtuzumab ozogamicin and inotuzumab ozogamicin play a crucial role in leukemia treatment. This study aims to explore multiple databases to identify adverse event (AE) signals that could enhance the safe use o...

Jonah Katranski,Sihua Liang,Deirdre Morris et al. Jonah Katranski et al.

Aim: This pharmacovigilance study aimed to investigate the prevalence of psychiatric AEs associated with currently available GLP-1 analogues by analysing publicly available national datasets from the US (FAERS), Canada (CVAROD) and Australia (DAEN).

Yang Ye,Bohan Fan,Xiaopeng Hu Yang Ye

While its safety profile has been characterized in LITESPARK clinical trials, real-world pharmacovigilance data remain limited....Conclusion: This study provided the first real-world pharmacovigilance assessment of belzutifan, confirming expected AEs while identifying emerging safety signals. Close monitoring of hematologic, respiratory, hepatic, and neurological toxicities is warranted.

Léonard Laurent,Baptiste Abbar,Kevin Bihan et al. Léonard Laurent et al.

In this pharmacovigilance study, all individual case safety reports (ICSRs) involving ICIs reported in the World Health Organization international pharmacovigilance database Vigibase up to January 2024 were extracted.

Gloria Erazo Montalvan,Guy Loic Nguefang Tchoukeu,Niempa Bacani et al. Gloria Erazo Montalvan et al.

By presenting this case, we want to highlight the importance of considering doxycycline as a potential cause of acute pancreatitis and underscore the need for heightened doxycycline pharmacovigilance to improve patient safety.

Valerio Liguori,Antonietta Anatriello,Alessia Zinzi et al. Valerio Liguori et al.

Aim: This study aims to explore the potential relationship between RDW alterations and treatment outcomes in patients treated with PD-1 inhibitors using pharmacovigilance data from Eudra Vigilance (EV).

Philippe Reix,Camille Audousset,Emmanuelle Girodon et al. Philippe Reix et al.

The number of pregnancies in women with cystic fibrosis (CF) has significantly increased in recent years, leading to a corresponding rise in the number of healthy infants exposed to cystic fibrosis transmembrane conductance regulator modula...

James Varley,Rahma Beyrouti,Richard Nicholas et al. James Varley et al.

Agreement was the poorest at lower JCV index, where positive/negative cutoffs inform risk stratification and pharmacovigilance protocols most significantly.

Olga Menang,Peter van Eeuwijk,Karen Maigetter et al. Olga Menang et al.

Background: The analysis and interpretation of pharmacovigilance data is an essential component of the continuous benefit-risk assessment of authorised medicinal products....Effective pharmacovigilance data analysis starts with data collection and involves critical activities, such as signal detection, that enable the generation of new information on marketed products, and inform safety-related regulatory actions....This real-time pharmacovigilance data analysis, which requires efficient collaboration and exchange of information between the key pharmacovigilance stakeholders, represents a challenge for many low- and middle-income countries (LMIC).Objectives:: To assess the capacity for analysis of pharmacovigilance...data in LMIC and to identify mechanisms to strengthen data analysis, interpretation and evidence-based pharmacovigilance decision-making....Four major themes emerged from the data and are proposed as transformative actions to strengthen pharmacovigilance data analysis and interpretation in LMIC: build on existing pharmacovigilance data analysis capacity rather than create new or parallel mechanisms; implement standardised procedures to enable

Alexandra Balshi,Grace Leuenberger,John Dempsey et al. Alexandra Balshi et al.

[This corrects the article DOI: 10.1212/CPJ.0000000000200462.]. © 2025 American Academy of Neurology.