Pharmacoepidemiol Drug Saf 2021 May 7. Epub 2021 May 7.
Safety Surveillance and Risk Management, Pfizer Inc., New York, New York, USA.
Int Immunopharmacol 2021 Jun 12;98:107818. Epub 2021 Jun 12.
Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing Institute of Respiratory Medicine, Beijing 100020, China. Electronic address:
Background: Although there have been a few studies reporting thromboembolic events (TEEs) in patients treated with immune checkpoint inhibitors (ICIs), the detailed profile of the TEEs and the prothrombotic effects of ICIs remain mostly unknown.Methods: Data from January 2004 to December 2019 in the FAERS database were retrieved. We investigated the clinical characteristics of the TEEs and conducted disproportionality analysis by using reporting odds ratios (ROR) to compare ICIs with the full database and other anti-cancer agents. Read More
Cardiovasc Drugs Ther 2021 Jun 14. Epub 2021 Jun 14.
Beth Israel Lahey Health, Department of Cardiovascular Medicine, Lahey Hospital and Medical Center, 41 Mall Road, Burlington, MA, 01805, USA.
Purpose: In PARADIGM-HF, sacubitril/valsartan showed a significant reduction in mortality and hospitalization for patients with heart failure with reduced ejection fraction. Despite proven efficacy, sacubitril/valsartan has moderate uptake in clinical practice. This study explores the safety profile of sacubitril/valsartan by comparing adverse events in RCT and real-world use. Read More
Front Pharmacol 2021 28;12:668765. Epub 2021 May 28.
Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France.
A plethora of methods and models of disproportionality analyses for safety surveillance have been developed to date without consensus nor a gold standard, leading to methodological heterogeneity and substantial variability in results. We hypothesized that this variability is inversely correlated to the robustness of a signal of disproportionate reporting (SDR) and could be used to improve signal detection performances. We used a validated reference set containing 399 true and false drug-event pairs and performed, with a frequentist and a Bayesian disproportionality method, seven types of analyses (model) for which the results were very unlikely to be related to actual differences in absolute risks of ADR. Read More
Drugs Real World Outcomes 2021 Jun 11. Epub 2021 Jun 11.
Department of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075, Ulm, Germany.
Background: To date, disproportionality analysis has been unable to demonstrate the increased bleeding risk associated with antidepressant drugs, especially selective serotonin reuptake inhibitors.Objective: We hypothesised that a potential signal for an increased bleeding risk may be mitigated by the effects of agents other than antidepressant drugs that are strongly associated with haemorrhages, especially antithrombotics. In addition, we investigated if the use of more specific search terms of the Medical Dictionary for Regulatory Activities facilitates the detection of signals. Read More
Front Psychiatry 2021 20;12:640264. Epub 2021 May 20.
First Department of Clinical Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
The latest decade, an emerging issue has been the abuse potential of the gabapentinoids pregabalin and gabapentin. The aim of our study was to assess this safety signal combining two different methods of surveillance: search analytics big data and the FDA spontaneous reporting system database. Analysis of big data and the FAERS was used to detect pregabalin's and gabapentin's abuse potential in comparison with two controls, clonazepam and levetiracetam, and further, the correlation between these domains was investigated. Read More