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Neurotherapeutics : the Journal of the... Sep 2023Migraine constitutes the world's second-leading cause of disability. Triptans, as serotonin 5-HT receptor agonists, remain the first-line treatment, despite discouraged...
Migraine constitutes the world's second-leading cause of disability. Triptans, as serotonin 5-HT receptor agonists, remain the first-line treatment, despite discouraged use in individuals at high cardiovascular risk. Lasmiditan, a selective lipophilic 5-HT agonist without vasoconstrictive effects, is an emerging option. We aimed to investigate the safety profile of lasmiditan in the WHO pharmacovigilance database (VigiBase) using a comparative disproportionality analysis with triptans. VigiBase was queried for all reports involving lasmiditan and triptans. Disproportionality analyses relied on the calculation of the information component (IC), for which 95% confidence interval (CI) lower bound positivity was required for signal detection. We obtained 826 reports involving lasmiditan. Overall, 10 adverse drug reaction classes were disproportionately reported with triptans, while only neurological (IC 1.6; 95% CI 1.5-1.7) and psychiatric (IC 1.5; 95% CI 1.3-1.7) disorders were disproportionately reported with lasmiditan. Sedation, serotonin syndrome, euphoric mood, and autoscopy had the strongest signals. When compared with triptans, 19 out of 22 neuropsychiatric signals persisted. The results of our analysis provide a more precise semiology of the neuropsychiatric effects of lasmiditan, with symptoms such as autoscopy and panic attacks. The cardiovascular adverse drug reaction risk with triptans was confirmed. In contrast, caution is warranted with lasmiditan use in patients with neurological or psychiatric comorbidities or serotonin syndrome risk. Our study was hindered by pharmacovigilance flaws, and further studies should help in validating these results. Our findings suggest that lasmiditan is a safe alternative for migraine treatment, especially when the neuropsychiatric risk is outweighed by the cardiovascular burden.
Topics: Humans; Tryptamines; Serotonin; Serotonin Syndrome; Receptors, Serotonin; Serotonin Receptor Agonists; Migraine Disorders; Drug-Related Side Effects and Adverse Reactions
PubMed: 37436579
DOI: 10.1007/s13311-023-01404-1 -
Human Vaccines & Immunotherapeutics Dec 2024This scoping review examines the role of digital solutions in active, participant-centered surveillance of adverse events following initial release of COVID-19 vaccines.... (Review)
Review
A scoping review of active, participant centred, digital adverse events following immunization (AEFI) surveillance of WHO approved COVID-19 vaccines: A Canadian immunization Research Network study.
This scoping review examines the role of digital solutions in active, participant-centered surveillance of adverse events following initial release of COVID-19 vaccines. The goals of this paper were to examine the existing literature surrounding digital solutions and technology used for active, participant centered, AEFI surveillance of novel COVID-19 vaccines approved by WHO. This paper also aimed to identify gaps in literature surrounding digital, active, participant centered AEFI surveillance systems and to identify and describe the core components of active, participant centered, digital surveillance systems being used for post-market AEFI surveillance of WHO approved COVID-19 vaccines, with a focus on the digital solutions and technology being used, the type of AEFI detected, and the populations under surveillance. The findings highlight the need for customized surveillance systems based on local contexts and the lessons learned to improve future vaccine monitoring and pandemic preparedness.
Topics: Humans; Adverse Drug Reaction Reporting Systems; Canada; COVID-19; COVID-19 Vaccines; Immunization; Vaccination; World Health Organization
PubMed: 38374618
DOI: 10.1080/21645515.2023.2293550 -
Vaccine Jul 2023Our near-real-time safety monitoring of 16 adverse events (AEs) following COVID-19 mRNA vaccination identified potential elevation in risk for six AEs following primary...
BACKGROUND
Our near-real-time safety monitoring of 16 adverse events (AEs) following COVID-19 mRNA vaccination identified potential elevation in risk for six AEs following primary series and monovalent booster dose administration. The crude association with AEs does not imply causality. Accordingly, we conducted robust evaluation of potential associations.
METHODS
We conducted two self-controlled case series studies of COVID-19 mRNA vaccines (BNT162b2 and mRNA-1273) in U.S. Medicare beneficiaries aged ≥ 65 years. Adjusted incidence rate ratio (IRRs) and 95 % confidence intervals (CIs) were estimated following primary series doses for acute myocardial infarction (AMI), pulmonary embolism (PE), immune thrombocytopenia (ITP), disseminated intravascular coagulation (DIC); and following monovalent booster doses for AMI, PE, ITP, Bell's Palsy (BP) and Myocarditis/Pericarditis (Myo/Peri).
RESULTS
The primary series study included 3,360,981 individuals who received 6,388,542 primary series doses; the booster study included 6,156,100 individuals with one monovalent booster dose. The AMI IRR following BNT162b2 primary series and booster was 1.04 (95 % CI: 0.91 to 1.18) and 1.06 (95 % CI: 1.003 to 1.12), respectively; for mRNA-1273 primary series and booster, 1.01 (95 % CI: 0.82 to 1.26) and 1.05 (95 % CI: 0.998 to 1.11), respectively. The hospital inpatient PE IRR following BNT162b2 primary series and booster was 1.19 (95 % CI: 1.03 to 1.38) and 0.86 (95 % CI: 0.78 to 0.95), respectively; for mRNA-1273 primary series and booster, 1.15 (95 % CI: 0.94 to 1.41) and 0.87 (95 % CI: 0.79 to 0.96), respectively. The studies' results do not support that exposure to COVID-19 mRNA vaccines elevate the risk of ITP, DIC, Myo/Peri, and BP.
CONCLUSION
We did not find an increased risk for AMI, ITP, DIC, BP, and Myo/Peri and there was not consistent evidence for PE after exposure to COVID-19 mRNA primary series or monovalent booster vaccines. These results support the favorable safety profile of COVID-19 mRNA vaccines administered in the U.S. elderly population.
Topics: United States; Humans; Adult; Aged; 2019-nCoV Vaccine mRNA-1273; BNT162 Vaccine; COVID-19; Medicare; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia; Vaccination; Bell Palsy; Facial Paralysis; Myocardial Infarction; Myocarditis; Pericarditis; Pulmonary Embolism; RNA, Messenger
PubMed: 37344261
DOI: 10.1016/j.vaccine.2023.06.014 -
CNS Neuroscience & Therapeutics Sep 2023Quetiapine, an atypical second-generation antipsychotic drug, is approved for treatment of schizophrenia, bipolar disorder, and depression. Due to the limitations of...
OBJECTIVE
Quetiapine, an atypical second-generation antipsychotic drug, is approved for treatment of schizophrenia, bipolar disorder, and depression. Due to the limitations of clinical trials, the association between quetiapine and rare cardiac adverse events (AEs) is still unclear. This study is to evaluate quetiapine-associated cardiac AEs through data mining of FDA Adverse Event Reporting System (FAERS).
METHODS
Reporting odds ratio (ROR) was used to quantify the signals of quetiapine-related cardiac AEs from the first quarter (Q1) of 2018-2022 Q1. Serious and nonserious cases were compared, and signals were prioritized using a rating scale.
RESULTS
A total of 1004 cases of quetiapine-associated cardiac AEs were identified, with 31 signals being detected, among which 13 AEs were identified as new and unexpected signals. Besides, nine and 22 cardiac AEs were identified as moderate and weak clinical priority. The median TTO for moderate and weak clinical priority signals were 0 and 4 days, respectively. All of the cardiac AEs had early failure type characteristics, suggesting that most of the patients developed cardiac AEs in a few days after quetiapine treatment, and that the risk of cardiac AEs occurrence would be gradually decreased over time.
CONCLUSION
Our study provided valuable evidence for health-care professionals to mitigate the risk of quetiapine-associated cardiac AEs based on an extensive analysis of a real-world, large-sample FAERS database, and prioritize cardiac AE signals.
Topics: United States; Humans; Quetiapine Fumarate; Adverse Drug Reaction Reporting Systems; United States Food and Drug Administration; Antipsychotic Agents; Bipolar Disorder
PubMed: 37032639
DOI: 10.1111/cns.14215 -
World Journal of Clinical Cases Jul 2023Pharmacovigilance (PV) is the activities and scientific studies conducted to detect, evaluate, understand or prevent adverse reactions and other drug-related problems.
BACKGROUND
Pharmacovigilance (PV) is the activities and scientific studies conducted to detect, evaluate, understand or prevent adverse reactions and other drug-related problems.
AIM
To define the awareness and experiences of the clinicians on PV and adverse drug reactions (ADRs) in Turkey.
METHODS
The study was cross-sectional and analytical. Data were obtained through a questionnaire. The questionnaire was sent e-mail. The survey was sent to 2030 physicians and 670 participated.
RESULTS
The most appropriate definition of PV was correctly defined by 53.9% of the participants. The most important goal of PV was correctly defined by 54.9% of the participants, and 27.3% of the participants were aware of the Turkish Pharmacovigilance Center. Nonsurgical physicians had better PV knowledge than surgical physicians. A total of 80.9% of the physicians who encountered ADRs, filled in the ADR notification form, and 8.8% received training on how to fill in the form. PV knowledge of the clinicians was not sufficient. Although half of the physicians encountered ADRs, the rates of seeing and filling in the ADR form were low.
CONCLUSION
Few of the physicians followed the current information about PV. The results provide more comprehensive data on PV practices and ADR reporting at a national level.
PubMed: 37583988
DOI: 10.12998/wjcc.v11.i20.4865 -
Psychiatry Research Sep 2023Eating disorders, characterized by abnormal eating, weight control behaviors or both include anorexia nervosa (AN) and bulimia nervosa (BN). We investigated their...
Eating disorders, characterized by abnormal eating, weight control behaviors or both include anorexia nervosa (AN) and bulimia nervosa (BN). We investigated their potential iatrogenic triggers, using real-world data from the WHO safety database (VigiBase®). VigiBase® was queried for all AN and BN reports. The reports were classified as `pediatric' or `adult' according to age. Disproportionality analyses relied on the Information Component (IC), in which a 95% confidence interval lower-end positivity was required to suspect a signal. Our queries yielded 309 AN and 499 BN reports. Isotretinoin was disproportionately reported in pediatric AN (IC 3.6; [2.6-4.3]), adult AN (IC 3.1; [1.7-4.0]), and pediatric BN (IC 3.9; [3.0-4.7]). Lamivudine (IC 4.2; [3.2-4.9]), nevirapine (IC 3.7; [2.6-4.6]), and zidovudine (IC 3.4; [2.0-4.3]) had the highest ICs in adult AN. AN was associated with isotretinoin, anticonvulsants in minors, and antiretroviral drugs in adults. In adults, BN was related to psychotropic and hormonally active drugs. Before treatment initiation, an anamnesis should seek out mental health conditions, allowing the identification of patients at risk of developing or relapsing into AN or BN. In addition to misuse, the hypothesis of iatrogenic triggers for AN and BN should also be considered.
Topics: Adult; Humans; Child; Anorexia Nervosa; Bulimia Nervosa; Isotretinoin; Iatrogenic Disease; World Health Organization
PubMed: 37611327
DOI: 10.1016/j.psychres.2023.115415 -
CNS Neuroscience & Therapeutics Apr 2024The relationship between Protein Convertase Subtilisin Kexin Type 9 inhibitor (PCSK9i) and psychiatric adverse events (AEs) remains unclear due to the limitations of...
BACKGROUND
The relationship between Protein Convertase Subtilisin Kexin Type 9 inhibitor (PCSK9i) and psychiatric adverse events (AEs) remains unclear due to the limitations of clinical trials. In this study, PCSK9i-related psychiatric AEs were realistically observed and systematically summarized in the real world by data mining the FDA AE Reporting System (FAERS).
METHOD
Total AEs between the third quarter of 2015 and the first quarter of 2023 were obtained from FAERS. Psychiatric AEs were identified using disproportionality analysis and clinical prioritization of signals using a rating scale, followed by univariate logistic regression to explore factors influencing psychiatric AEs.
RESULTS
Psychiatric AEs accounted for 6.7% of the total number of PCSK9i reports. Eighteen psychiatric AEs were defined as PCSK9i-related psychiatric adverse events (ppAEs) (lower 95% CI of both ROR >1 and IC > 0). The median age of ppAE reports was 68 years, and female patients accounted for 22.67% of reports, including 41.40% of reports with a serious outcome. Eleven (61.11%) and seven (38.89%) ppAEs were classified as weak and moderate clinical priority, respectively. The median time to onset of ppAEs was 149 and 196 days after treatment with evolocumab and alirocumab, respectively. Patients weighing ≥80 kg were 1.59 times more likely to experience ppAEs.
CONCLUSION
The results of this study facilitate the prioritization of psychiatric AE signals by healthcare professionals with the goal of mitigating the risk of PCSK9i-related psychiatric AEs. However, as an exploratory study, our findings need to be confirmed in large-scale prospective studies.
Topics: Aged; Female; Humans; Databases, Factual; Mental Disorders; PCSK9 Inhibitors; Pharmacovigilance; Proprotein Convertase 9; Prospective Studies
PubMed: 37950531
DOI: 10.1111/cns.14522 -
Therapie 2023Casirivimab and imdevimab (Ronapreve®) are two recombinant human monoclonal antibodies (mAbs) that bind to the severe acute respiratory syndrome coronavirus 2...
INTRODUCTION
Casirivimab and imdevimab (Ronapreve®) are two recombinant human monoclonal antibodies (mAbs) that bind to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, preventing the virus from entering cells. In March 2021, this drug was granted emergency use authorisation (EUA) in France for early treatment of COVID-19 in patients at increased risk of progression to severe COVID-19. In August/September 2021, the indication was expanded to COVID-19 prevention (pre- or post-exposure prophylaxis) and treatment of hospitalised patients requiring non-invasive oxygen therapy. The aim of the study was to better describe the adverse drug reaction (ADR) profile and detect safety signals of this new drug used in COVID-19 treatment.
METHODS
We described ADR profile with casirivimab/imdevimab reported as suspect/interacting drug to the French pharmacovigilance network and the pharmaceutical company between 17/03/2021 and 30/06/2022. Data presented correspond to the 2 periods of the pharmacovigilance survey: the first carried out by the pharmaceutical company for curative and prophylactic uses and the second by Toulouse university regional pharmacovigilance center (RPVC).
RESULTS
A total of 384 reports were analysed and 256 were "serious". ADR profile was comparable between the 2 periods and between curative and prophylactic use, corresponding to expected ADRs such as infusion-related reactions and hypersensitivity, inefficiencies or worsened infections and deaths. Two potential pharmacovigilance signals were also studied: acute pulmonary oedemas and sudden deaths.
DISCUSSION
No pharmacovigilance signal emerged from this 15 months French pharmacovigilance survey. Moreover data from published studies are also reassuring. This pharmacovigilance survey was the first one for the new version of EUA and with a new ADR reporting process i.e. declaration to the RPVC instead of the pharmaceutical company. Casirivimab/imdevimab is no longer used in France today but we continue to monitor this drug for any future evidence of resurgent activity on a new variant of Sars-CoV-2.
PubMed: 36918316
DOI: 10.1016/j.therap.2023.02.004 -
Frontiers in Microbiology 2023Ketoprofen, a bicyclic non-steroidal anti-inflammatory drug commonly used in human and veterinary medicine, has recently been cited as an environmental contaminant that... (Review)
Review
Ketoprofen, a bicyclic non-steroidal anti-inflammatory drug commonly used in human and veterinary medicine, has recently been cited as an environmental contaminant that raises concerns for ecological well-being. It poses a growing threat due to its racemic mixture, enantiomers, and transformation products, which have ecotoxicological effects on various organisms, including invertebrates, vertebrates, plants, and microorganisms. Furthermore, ketoprofen is bioaccumulated and biomagnified throughout the food chain, threatening the ecosystem function. Surprisingly, despite these concerns, ketoprofen is not currently considered a priority substance. While targeted eco-pharmacovigilance for ketoprofen has been proposed, data on ketoprofen as a pharmaceutical contaminant are limited and incomplete. This review aims to provide a comprehensive summary of the most recent findings (from 2017 to March 2023) regarding the global distribution of ketoprofen in the environment, its ecotoxicity towards aquatic animals and plants, and available removal methods. Special emphasis is placed on understanding how ketoprofen affects microorganisms that play a pivotal role in Earth's ecosystems. The review broadly covers various approaches to ketoprofen biodegradation, including whole-cell fungal and bacterial systems as well as enzyme biocatalysts. Additionally, it explores the potential of adsorption by algae and phytoremediation for removing ketoprofen. This review will be of interest to a wide range of readers, including ecologists, microbiologists, policymakers, and those concerned about pharmaceutical pollution.
PubMed: 37608946
DOI: 10.3389/fmicb.2023.1200108 -
International Journal of Clinical... Aug 2023Only 5-10% of all adverse drug reactions (ADRs) are reported. Mechanisms to support patient and public reporting offer numerous advantages to health care systems... (Review)
Review
BACKGROUND
Only 5-10% of all adverse drug reactions (ADRs) are reported. Mechanisms to support patient and public reporting offer numerous advantages to health care systems including increasing reporting rate. Theory-informed insights into the factors implicated in patient and public underreporting are likely to offer valuable opportunity for the development of effective reporting-interventions and optimization of existing systems.
AIM
To collate, summarize and synthesize the reported behavioral determinants using the theoretical domains framework (TDF), that influence patient and public reporting of ADRs.
METHOD
Cochrane, CINAHL, Web of science, EMBASE and PubMed were systematically searched on October 25th, 2021. Studies assessing the factors influencing public or patients reporting of ADRs were included. Full-text screening, data extraction and quality appraisal were performed independently by two authors. Extracted factors were mapped to TDF.
RESULTS
26 studies were included conducted in 14 countries across five continents. Knowledge, social/professional role and identity, beliefs about consequences, and environmental context and resources, appeared to be the most significant TDF domains that influenced patient and public behaviors regarding ADR reporting.
CONCLUSION
Studies included in this review were deemed of low risk of bias and allowed for identification of key behavioural determinants, which may be mapped to evidence-based behavioral change strategies that facilitate intervention development to enhance rates of ADR reporting. Aligning strategies should focus on education, training and further involvement from regulatory bodies and government support to establish mechanisms, which facilitate feedback and follow-ups on submitted reports.
Topics: Humans; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Patients; Government; Pharmacovigilance
PubMed: 37247158
DOI: 10.1007/s11096-023-01591-z