Results 51 to 60 of about 3,513 (158)

Using VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites [PDF]

, 2015
Background Substandard medicines, whether the result of intentional manipulation or lack of compliance with good manufacturing practice (GMP) or good distribution practice (GDP), pose a significant potential threat to patient safety.
Karimi, Ghazaleh, Rokiah Isahak, Su-Jung Lee, Camilli, Sara, Isahak, Rokiah, Maria Andér, Mukesh Dheda, Sarah Vaughan, Lee, Su-Jung, Sara Camilli, Ghazaleh Karimi, G. Niklas Norén, Vaughan, Sarah, Ander, Maria, Tan Siew Har, Juhlin, Kristina, Har, Tan Siew, Norén, G. Niklas,, Kristina Juhlin, Caduff, Pia, Dheda, Mukesh, Pia Caduff   +21 more
core   +1 more source

Montelukast and Nightmares : Further Characterisation Using Data from VigiBase

, 2022
Introduction Montelukast is a medicine indicated for use in asthma. Psychiatric disorders including nightmares have not been described in clinical trials but during recent years have been included in the product information as having been reported post ...
Watson, Sarah, Taavola, Henric,, Watson, Sarah,, Attalla, Marian, Kaminsky, Elenor,, Yue, Qun-Ying,, Kaminsky, Elenor, Yue, Qun-Ying, Attalla, Marian,, Taavola, Henric   +9 more
core   +1 more source

A Description of Acute Renal Failure and Nephrolithiasis Associated With Sodium–Glucose Co-Transporter 2 Inhibitor Use: A VigiBase Study

Frontiers in Pharmacology, 2022
Background: The Food and Drug Administration issued a warning on the risk of acute kidney injury and a signal of nephrolithiasis for patients using sodium–glucose co-transporter 2 inhibitors (SGLT2i).
Ioana Frent, Daniel Leucuta, Camelia Bucsa, Andreea Farcas, Florin Casoinic, Cristina Mogosan   +5 more
doaj   +1 more source

Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands—A contribution of the ConcePTION project

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Although regulatory responses to safety signals have been studied, pregnancy‐specific data and their dissemination to medical professionals remain unclear. This study examined the characteristics and temporal trends of teratological safety signals prompting the European Medicines Agency to implement risk minimization measures.
Yrea R. J. van Rijt‐Weetink, Rosanne E. Huisman, Jan‐Peter van Wieringen, H. J. M. J. (Ineke) Crijns, Florence P. A. M. van Hunsel, Anneke L. M. Passier, Sander Borgsteede, A. C. G. (Toine) Egberts, Laura M. Yates, Eugène P. van Puijenbroek   +9 more
wiley   +1 more source

Computerized systems and databases for pharmacovigilance in Russia

Реальная клиническая практика: данные и доказательства
The results of identifying new risks for pharmacovigilance systems and databases in Russia, including the Roszdravnadzor's web-based pharmacovigilance system, are presented.
B. K. Romanov, E. N. Saykina, E. Yu. Baidikova, U. M. Shirokova, E. D. Shchukin   +4 more
doaj   +1 more source

A Global Perspective of Childhood Vaccinations: Past, Present, and Future—From Smallpox to mRNA

Acta Paediatrica, EarlyView.
ABSTRACT Childhood immunisation is one of the most successful public health interventions in history, preventing millions of deaths and substantially reducing global child mortality. This mini‐review summarises the historical development of childhood vaccines, the role of global coordination in expanding immunisation coverage, and the innovations that ...
Tobias Alfvén, Tania Reza, Alieu Sowe
wiley   +1 more source

Characteristics of cardiac ADRs associated with immune checkpoint inhibitor therapy in Vigibase (last accessed 11/23/2019)^+b'*'.

, 2022
Characteristics of cardiac ADRs associated with immune checkpoint inhibitor therapy in Vigibase (last accessed 11/23/2019)+b'*'.
Wesley H. Chou (14040992), Eugene B. Cone (14040977), Kerry Laing Kilbridge (14040995), Junaid Nabi (14040989), David-Dan Nguyen (14040986), Quoc-Dien Trinh (398904), Lorine Haeuser (14040980), Maya Marchese (9520934), Rana R. McKay (11522106), Joachim Noldus (4052596), Stephen W. Reese (14040983)   +10 more
core   +1 more source

Ischaemic stroke and 5‐fluorouracil or capecitabine: A systematic review and meta‐analysis of harms and a retrospective study of the WHO pharmacovigilance database

British Journal of Pharmacology, EarlyView.
Abstract Aim Fluoropyrimidines, including 5‐fluorouracil (5‐FU) and capecitabine, are cornerstone antineoplastic agents for cancer. Case reports suggest that these drugs may be associated with an under‐recognised risk of ischaemic stroke or transient ischaemic attack (TIA).
Sophie Nguyen, Ines Bentahrour, Camille Guerin, Charles Dolladille, Angélique Da Silva, François Cherifi, Elise‐Marie Minoc, Pierre‐Marie Morice, Nicolas Jacquin, Christophe Le Tourneau, Joachim Alexandre, Ahmad Nehme, Etienne Bastien   +12 more
wiley   +1 more source

Refining the treatment of immune checkpoint inhibitor–associated myocarditis: Challenges, innovations and rechallenge considerations

British Journal of Pharmacology, EarlyView.
Immune checkpoint inhibitor (ICI)‐associated myocarditis has emerged as a severe and clinically complex immune‐related toxicity that poses significant challenges for therapeutic decision‐making in routine cardio‐oncological care. High‐dose corticosteroids remain the first‐line therapy, yet their timing, dosage and tapering require careful clinical ...
Raluca I. Mincu, Lisa Zimmer, Dimitra Vlachopoulou, Elias Haj‐Yehia, Julia Hoffmann, Lars Michel, Elisabeth Livingstone, Dirk Schadendorf, Alpaslan Tasdogan, Matthias Totzeck, Tienush Rassaf   +10 more
wiley   +1 more source

Global Pharmacovigilance: Data for 2017–2025 with an Assessment of the Impact of the COVID-19 Pandemic

Безопасность и риск фармакотерапии
INTRODUCTION. Continuous assessment of the dynamics of quantitative indicators and the impact of extraordinary events on them, such as the COVID-19 pandemic, is critically important for the development of the international drug safety monitoring program ...
B. K. Romanov, E. Yu. Baidikova, D. A. Kozlov, U. M. Shirokova, E. D. Shchukin   +4 more
doaj   +1 more source