Article
Psychiatry
Georgios Papazisis, Dimitrios Spachos, Spyridon Siafis, Niki Pandria, Eleni Deligianni, Ioannis Tsakiridis, Antonios Goulas
Summary: The study identified a potential for abuse of pregabalin and gabapentin through analysis of FAERS database and big data search analytics. Comparison with clonazepam and levetiracetam showed higher rankings for pregabalin and gabapentin. A correlation was found between FAERS and Google search results, suggesting the potential use of these methods for detecting drug abuse-related safety signals.
FRONTIERS IN PSYCHIATRY
(2021)
Article
Public, Environmental & Occupational Health
Gianmario Candore, Sebastian Monzon, Jim Slattery, Loris Piccolo, Rodrigo Postigo, Xavier Xurz, Sabine Strauss, Peter Arlett
Summary: The European Union legislation requiring submission of non-serious reports to EudraVigilance has led to an increase in the proportion of non-serious reports, from less than 25% to slightly above 60%. Addition of non-serious reports to the signal detection process resulted in a small overall increase in signals of disproportionate reporting, with slight improvement in sensitivity and unchanged efficiency. Further monitoring is needed to assess the impact on signal detection and the qualitative impact of non-serious reports on signal detection.
Article
Psychiatry
Dainora Cepaityte, Spyridon Siafis, Toine Egberts, Stefan Leucht, Dimitrios Kouvelas, Georgios Papazisis
Summary: Studies have shown a potential association between specific antipsychotic drugs like Clozapine and Olanzapine with an increased risk of pneumonia. The use of multiple antipsychotic drugs may also be associated with an increased risk of pneumonia. Further research and clinical assessment are needed to validate these safety signals.
SCHIZOPHRENIA BULLETIN
(2021)
Article
Pharmacology & Pharmacy
S. Lee, J. W. Yang, S. Y. Jung, M. S. Kim, D. K. Yon, S. W. Lee, H-C Kang, E. Dragioti, K. Tizaoui, L. Jacob, A. Koyanagi, J-E Salem, K. Kostev, A. Lascu, J. Shin, J. H. Kim, L. Smith
Summary: This study found that remdesivir, a novel drug for treating COVID-19, did not show significant association with adverse neurologic or psychiatric reactions in real-world settings through an international pharmacovigilance cohort study.
EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES
(2021)
Article
Microbiology
Tyler W. Ackley, Dayna McManus, Jeffrey E. Topal, Brian Cicali, Sunish Shah
Summary: Based on prescribing guidance, remdesivir is not recommended for SARS-CoV-2 patients with renal disease due to lack of safety data. A retrospective study on hospitalized patients receiving remdesivir for SARS-CoV-2 compared safety outcomes between patients with different estimated creatinine clearances. Even though patients with eCrCl <30 ml/min had more comorbidities, there was no significant difference in the occurrence of acute kidney injury at the end of treatment compared to patients with eCrCl >= 30 ml/min.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2021)
Article
Health Care Sciences & Services
Amelle Mouffak, Marion Lepelley, Bruno Revol, Claire Bernardeau, Francesco Salvo, Antoine Pariente, Matthieu Roustit, Jean-Luc Cracowski, Charles Khouri
Summary: The study systematically reviewed and evaluated the misinterpretation of pharmacovigilance disproportionality analysis results in published studies. Results showed a high frequency of spin in abstracts, with inappropriate interpretations, causal language use, and failure to acknowledge limitations being common forms of spin. The findings suggest a need for greater attention to accurate reporting and interpretation in pharmacovigilance studies.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2021)
Article
Pharmacology & Pharmacy
Yuanxuan Cai, Linhui Yang, Xiaofang Shangguan, Yuhang Zhao, Rui Huang
Summary: Cephalosporins are commonly used in clinical treatment of children, but the safety of these drugs remains uncertain due to lack of strong evidence. A study analyzing adverse drug reaction reports in children aged 0-4 found that severe ADRs were more frequently reported for certain cephalosporins, indicating potential safety concerns. In signal mining analysis, multiple signals of off-label ADRs were identified, highlighting the need for improved labeling and monitoring of ADRs in children using cephalosporins.
FRONTIERS IN PHARMACOLOGY
(2021)
Review
Biochemical Research Methods
Yoshihiro Noguchi, Tomoya Tachi, Hitomi Teramachi
Summary: Continuous evaluation of drug safety is essential post-approval, with spontaneous reporting systems being an important tool for timely detection of adverse events. In addition to traditional disproportionality analysis, new signal detection methods exist but may be prone to misinterpretation.
BRIEFINGS IN BIOINFORMATICS
(2021)
Article
Multidisciplinary Sciences
Jeong-Eun Lee, Ju Hwan Kim, Ji-Hwan Bae, Inmyung Song, Ju-Young Shin
Summary: This study investigated the utility of supervised machine learning algorithms (GBM and RF) for timely detection of safety signals in the Korea Adverse Event Reporting System. The results demonstrate reliable performance of both algorithms in detecting early safety signals.
SCIENTIFIC REPORTS
(2022)
Article
Oncology
Fangyuan Hu, Yinghong Zhai, Lei Yuan, Jizhou Liang, Jinfang Xu, Xiaojing Guo, Xiang Zhou, Zhen Lin, Jinhai Sun, Xiaofei Ye, Jia He
Summary: The study found a spectrum of renal adverse events in ICIs regimens, which may be reinforced by combination with chemotherapy. Compared to sole ICIs regimens, ICIs plus chemotherapy strategy reported more renal toxicities but lower fatality outcome rates. It is crucial for clinicians to ensure a balance between durable clinical effects and potential renal toxicities in the latest immunotherapy strategies, especially with the increasing popularity of ICIs, including combination strategies.
Article
Oncology
Alexandre Crosnier, Chadi Abbara, Morgane Cellier, Laurence Lagarce, Marina Babin, Delphine Bourneau-Martin, Marie Briet
Summary: This study found that the renal toxicity of anti-EGFR drugs is primarily related to renal failure in the context of digestive toxicity. Signals of disproportionate reporting were observed for afatinib and erlotinib with acute kidney injury, and for afatinib, cetuximab, and erlotinib with renal failure. Additionally, erlotinib was associated with haemolytic and uremic syndrome and thrombotic microangiopathy.
Article
Pharmacology & Pharmacy
Xiaotong Li, Liyuan Zhou, Martina Gaggl, Alan C. Kinlaw, Zhuoyue Gou, Yang Xu, Jingkai Wei, Tiansheng Wang
Summary: Using data from the US Food and Drug Administration Adverse Event Reporting System, this study investigated the disproportionate reporting of remdesivir-associated AKI in COVID-19 patients over time. The results showed that while there was a significant association between remdesivir and AKI and renal disorder compared to other medications during the entire study period, the signals disappeared in the most recent quarter of 2022, suggesting remdesivir may not be nephrotoxic.
INTERNATIONAL JOURNAL OF CLINICAL PHARMACY
(2023)
Article
Microbiology
Sunish Shah, Tyler W. Ackley, Jeffrey E. Topal
Summary: The study found that there was no significant association between the use of injectable solution or lyophilized powder of remdesivir in treating SARS-CoV-2 patients and acute kidney injury. Additionally, there was no significant difference in early discontinuation rates due to abnormal liver function tests between the two formulations.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2021)
Article
Pharmacology & Pharmacy
Ioana Frent, Daniel Leucuta, Camelia Bucsa, Andreea Farcas, Florin Casoinic, Cristina Mogosan
Summary: Most of the adverse reactions associated with gliflozins involved serious cases of acute renal failure (ARF) and nephrolithiasis. The majority of these cases were reported in the American regions and affected patients aged 45-64. Canagliflozin was the most commonly involved gliflozin, and the majority of the reports were serious.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Pharmacology & Pharmacy
Ji-Hwan Bae, Yeon-Hee Baek, Jeong-Eun Lee, Inmyung Song, Jee-Hyong Lee, Ju-Young Shin
Summary: This study evaluated the feasibility of machine learning algorithms in detecting ADR signals of nivolumab and docetaxel, and found that GBM outperformed traditional methods in detecting new ADR signals.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Pharmacology & Pharmacy
Serena Romani, Audrey Fresse, Nadege Parassol-Girard, Alexandre Gerard, Mathieu Levraut, Samir Yamani, Elise K. Van Obberghen, Antoine Pariente, Fanny Rocher, Delphine Viard, Milou-Daniel Drici
Summary: Following changes in the excipients of Levothyrox (R), the French Pharmacovigilance Database received numerous spontaneous reports of adverse drug reactions associated with the new formula. These reports were found to be more frequent, with different characteristics compared to reports related to other drugs.
FUNDAMENTAL & CLINICAL PHARMACOLOGY
(2022)
Article
Pediatrics
Alexandre O. Gerard, Audrey Fresse, Myriam Gast, Diane Merino, Pierre Gourdan, Audrey Laurain, Irene Margaritis, Pierre-Alexis Gauci, Fanny Huret, Nadege Parassol, Fanny Rocher
Summary: This case highlights the importance of therapeutic education and the need for harmonization of the regulation and labeling of dietary supplements and medications containing vitamin D.
FRONTIERS IN PEDIATRICS
(2022)
Letter
Pharmacology & Pharmacy
Alexandre O. Gerard, Diane Merino, Milou-Daniel Drici
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2022)
Article
Clinical Neurology
Alexandre O. Gerard, Diane Merino, Elise K. Van Obberghen, Fanny Rocher, Alexandre Destere, Michel Lanteri-Minet, Milou-Daniel Drici
Summary: This study found a significant association between CGRP-targeting drugs and Raynaud's phenomenon, with a stronger association compared to other drugs. However, caution is needed in the use of CGRP-targeting drugs due to limitations such as missing data and reporting bias.
JOURNAL OF HEADACHE AND PAIN
(2022)
Article
Urology & Nephrology
Alexandre O. Gerard, Susana Barbosa, Nadege Parassol, Marine Andreani, Diane Merino, Marion Cremoni, Audrey Laurain, Sylvine Pinel, Delphine Bourneau-Martin, Fanny Rocher, Vincent L. M. Esnault, Delphine Borchiellini, Antoine Sicard, Milou-Daniel Drici
Summary: Immune checkpoint inhibitors (ICIs) can lead to immune-related adverse events (IRAEs), including acute tubulointerstitial nephritis. This study compared patients with renal IRAEs (ICI-AKI) to those with other IRAEs and found that ICI-AKI patients were older, had a higher prevalence of chronic kidney disease, and were more likely to be treated with fluindione, NSAIDs, or PPIs.
CLINICAL KIDNEY JOURNAL
(2022)
Letter
Urology & Nephrology
Alexandre O. Gerard, Diane Merino, Audrey Laurain, Marion Cremoni, Marine Andreani, Fanny Rocher, Alexandre Destere, Vincent L. M. Esnault, Antoine Sicard, Milou-Daniel Drici
KIDNEY INTERNATIONAL REPORTS
(2022)
Article
Pharmacology & Pharmacy
Delphine Bourneau-Martin, Marina Babin, Aurelie Grandvuillemin, Charlotte Mullet, Francesco Salvo, Allison Singier, Morgane Cellier, Audrey Fresse, Claire de Canecaude, Tessa Pietri, Guillaume Drablier, Helene Geniaux, Laurence Lagarce, Marie-Laure Laroche, Marie Briet
Summary: This study evaluates the consequences of drug shortages on patient safety and finds that it can lead to adverse drug reactions, medication errors, and inefficiency. It highlights the need for a global health policy program to limit drug shortages and to provide better information to patients and healthcare professionals in order to reduce risks.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Taghla Ahmed-Khalifa, Romain Gillet, Marie Blonski, Fabien Rech, Audrey Fresse, Pierre Gillet, Luc Taillandier, Nadine Petitpain
Summary: Conservative treatment is effective for progestogen-induced meningioma, especially for CPA. Discontinuation of progestogen is necessary upon diagnosis of meningioma.
FUNDAMENTAL & CLINICAL PHARMACOLOGY
(2023)
Article
Oncology
Alexandre O. Gerard, Diane Merino, Alexis Charbinat, Joseph Fournier, Alexandre Destere, Michael Loschi, Thomas Cluzeau, Antoine Sicard, Milou-Daniel Drici
Summary: CAR-T cell therapy may lead to acute renal failure and various hydroelectrolytic disorders, as supported by this study using large-scale real-life data.
Editorial Material
Pharmacology & Pharmacy
Viktoryia Prontskus, Audrey Fresse, Melissa Yelehe, Mathilde Beurrier, Pierre Gillet
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Pharmacology & Pharmacy
Viktoryia Prontskus, Audrey Fresse, Melissa Yelehe-Okouma, Anthony Facile, Tessa Pietri, Corinne Simon, Cosette Le Souder, Mathilde Beurrier, Pierre Gillet
Summary: COVID-19 vaccination does not pose a higher risk of rheumatoid arthritis (RA) compared with other nonlive vaccines. Cases of new-onset RA or flare-ups in individuals with pre-existing RA were reported in pharmacovigilance databases. The majority of RA cases occurred after the first dose and the time between vaccination and disease onset was shorter in the flare-up group.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Psychology, Developmental
Diane Merino, Alexandre O. Gerard, Thibaud Lavrut, Florence Askenazy, Susanne Thummler, Francois Montastruc, Milou-Daniel Drici
Summary: Catatonia is characterized by psychomotor alterations and reduced contact with the environment. This study aimed to characterize age-dependent patterns of pediatric drug-induced catatonia using real-world data from the WHO safety database.
EUROPEAN CHILD & ADOLESCENT PSYCHIATRY
(2023)
Article
Psychiatry
Diane Merino, Alexandre Olivier Gerard, Alexandre Destere, Florence Askenazy, Emmanuelle Dor, Michel Benoit, Faredj Cherikh, Milou-Daniel Drici
Summary: This study investigates the potential triggers for eating disorders, specifically anorexia nervosa (AN) and bulimia nervosa (BN). Using real-world data from the WHO safety database, the study finds a correlation between certain drugs such as isotretinoin, lamivudine, nevirapine, and zidovudine, and the development or relapse of AN and BN. It suggests that mental health conditions should be assessed before treatment initiation to identify patients at risk.
PSYCHIATRY RESEARCH
(2023)
Letter
Medicine, General & Internal
Alexander O. Gerard, Audrey Laurain, Vincent L. M. Esnault
NEW ENGLAND JOURNAL OF MEDICINE
(2022)
Correction
Pharmacology & Pharmacy
Alexandre O. Gerard, Audrey Laurain, Audrey Fresse, Nadege Parassol, Marine Muzzone, Fanny Rocher, Vincent L. M. Esnault, Milou-Daniel Drici
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2022)