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1.
Int J Environ Res Public Health ; 19(7)2022 Mar 31.
Article in English | MEDLINE | ID: covidwho-1785644

ABSTRACT

OBJECTIVES: To compare neurologists' knowledge, practice, and barriers of pharmacovigilance (PV) process among patients with epilepsy in Poland and Egypt. METHODS: It was an international study that used an online questionnaire e-mailed to neurologists registered to practice in Poland and Egypt. RESULTS: Most of the neurologists were familiar with the definition of PV and adverse drug reactions (ADRs), but relatively few neurologists knew where to report ADRs, especially the Egyptian neurologists. Only 31.11% of the neurologists from Egypt and 39.90% neurologists from Poland declared that they had reported ADRs at least once during their professional practice, and few of them declared the regular reporting of such incidents. The main reason for the neurologists not reporting ADRs was the lack of time and a conviction that reporting ADRs would be an additional burden that would generate extra work. CONCLUSION: The standards of pharmacovigilance process, safety control, and quality are not the same throughout the world. System-regulated PV stabilization in a country translates into the practice of maintaining PV. Monitoring the safety of pharmacotherapy and knowledge of risks associated with ADRs should be included in the academic curricula of physician courses.


Subject(s)
Drug-Related Side Effects and Adverse Reactions , Epilepsy , Adverse Drug Reaction Reporting Systems , Cross-Sectional Studies , Egypt , Epilepsy/drug therapy , Health Knowledge, Attitudes, Practice , Humans , Neurologists , Pharmacovigilance , Poland
2.
Pharmacol Res Perspect ; 10(2): e00931, 2022 04.
Article in English | MEDLINE | ID: covidwho-1782680

ABSTRACT

The aim of this study was to estimate healthcare costs and mortality associated with serious fluoroquinolone-related adverse reactions in Finland from 2008 to 2019. Serious adverse reaction types were identified from the Finnish Pharmaceutical Insurance Pool's pharmaceutical injury claims and the Finnish Medicines Agency's Adverse Reaction Register. A decision tree model was built to predict costs and mortality associated with serious adverse drug reactions (ADR). Severe clostridioides difficile infections, severe cutaneous adverse reactions, tendon ruptures, aortic ruptures, and liver injuries were included as serious adverse drug reactions in the model. Direct healthcare costs of a serious ADR were based on the number of reimbursed fluoroquinolone prescriptions from the Social Insurance Institution of Finland's database. Sensitivity analyses were conducted to address parameter uncertainty. A total of 1 831 537 fluoroquinolone prescriptions were filled between 2008 and 2019 in Finland, with prescription numbers declining 40% in recent years. Serious ADRs associated with fluoroquinolones lead to estimated direct healthcare costs of 501 938 402 €, including 11 405 ADRs and 3,884 deaths between 2008 and 2019. The average mortality risk associated with the use of fluoroquinolones was 0.21%. Severe clostridioides difficile infections were the most frequent, fatal, and costly serious ADRs associated with the use of fluoroquinolones. Although fluoroquinolones continue to be generally well-tolerated antimicrobials, serious adverse reactions cause long-term impairment to patients and high healthcare costs. Therefore, the risks and benefits should be weighed carefully in antibiotic prescription policies, as well as with individual patients.


Subject(s)
Anti-Bacterial Agents/adverse effects , Fluoroquinolones/adverse effects , Health Care Costs/statistics & numerical data , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Anti-Bacterial Agents/economics , Databases, Factual/statistics & numerical data , Decision Trees , Drug-Related Side Effects and Adverse Reactions/economics , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/mortality , Finland , Fluoroquinolones/economics , Humans , Retrospective Studies
4.
Int J Environ Res Public Health ; 19(6)2022 03 10.
Article in English | MEDLINE | ID: covidwho-1765706

ABSTRACT

BACKGROUND: Monitoring of adverse drug reactions (ADRs) to antimicrobials is important, as they can cause life-threatening illness, permanent disabilities, and death. We assessed country-wide ADR reporting on antimicrobials and their outcomes. METHODS: A cross-sectional study was conducted using individual case safety reports (ICSRs) entered into the national pharmacovigilance database (VigiFlow) during 2017-2021. RESULTS: Of 566 ICSRs, inconsistent reporting was seen, with the highest reporting in 2017 and 2019 (mass drug campaigns for deworming), zero reporting in 2018 (reasons unknown), and only a handful in 2020 and 2021 (since COVID-19). Of 566 ICSRs, 90% were for antiparasitics (actively reported during mass campaigns), while the rest (passive reporting from health facilities) included 8% antibiotics, 7% antivirals, and 0.2% antifungals. In total, 90% of the reports took >30 days to be entered (median = 165; range 2-420 days), while 44% had <75% of all variables filled in (desired target = 100%). There were 10 serious ADRs, 18 drug withdrawals, and 60% of ADRs affected the gastrointestinal system. The patient outcomes (N-566) were: recovered (59.5%), recovering (35.5%), not recovered (1.4%), death (0.2%), and unknown (3.4%). There was no final ascertainment of 'recovering' outcomes. CONCLUSIONS: ADR reporting is inconsistent, with delays and incomplete data. This is a wake-up call for introducing active reporting and setting performance targets.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Adverse Drug Reaction Reporting Systems , COVID-19/drug therapy , COVID-19/epidemiology , Cross-Sectional Studies , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , Sierra Leone
5.
G Ital Cardiol (Rome) ; 23(4): 244-246, 2022 Apr.
Article in Italian | MEDLINE | ID: covidwho-1765605

ABSTRACT

In the clinical research arsenal, the COVID-19 vaccines are the strongest weapons against the most important worldwide sanitary crisis of the last centuries. Even if vaccine adverse events have mild clinical relevance, several thromboembolic events occurring after adenoviral recombinant vaccine administration have been reported. Cases of myocarditis and pericarditis after administration of mRNA vaccines have also recently been described. We report the case of a patient who suffered from two rare adverse events after BNT162b2 mRNA vaccine administration (Pfizer-BioNTech): acute myocarditis and pulmonary embolism. Although the temporal consequentiality does not demonstrate a causal link, the strong analogies emerging in the latest clinical reports suggest a possible relation. Further studies are needed to understand the potential mechanisms of myocardial damage and atypical thrombosis. Despite the favorable and self-limiting clinical course of post-vaccinal myocarditis, in these cases a tight follow-up is advisable and vaccine adverse event reporting remains mandatory, especially if not described during pivotal clinical trials.


Subject(s)
COVID-19 , Myocarditis , Pulmonary Embolism , Adverse Drug Reaction Reporting Systems , COVID-19 Vaccines/adverse effects , Humans , Myocarditis/chemically induced , Pulmonary Embolism/etiology , Vaccines, Synthetic/adverse effects
6.
Int J Mol Sci ; 23(6)2022 Mar 10.
Article in English | MEDLINE | ID: covidwho-1760646

ABSTRACT

The impressive advances in the knowledge of biomarkers and molecular targets has enabled significant progress in drug therapy for crucial diseases such as cancer. Specific areas of pharmacology have contributed to these therapeutic outcomes-mainly targeted therapy, immunomodulatory therapy, and gene therapy. This review focuses on the pharmacological profiles of these therapeutic classes and intends, on the one hand, to provide a systematic definition and, on the other, to highlight some aspects related to pharmacovigilance, namely the monitoring of safety and the identification of potential toxicities and adverse drug reactions. Although clinicians often consider pharmacovigilance a non-priority area, it highlights the risk/benefit ratio, an essential factor, especially for these advanced therapies, which represent the most innovative and promising horizon in oncology.


Subject(s)
Antineoplastic Agents , Drug-Related Side Effects and Adverse Reactions , Adverse Drug Reaction Reporting Systems , Antineoplastic Agents/adverse effects , Drug-Related Side Effects and Adverse Reactions/drug therapy , Drug-Related Side Effects and Adverse Reactions/etiology , Genetic Therapy , Humans , Medical Oncology , Molecular Targeted Therapy/adverse effects , Pharmacovigilance
7.
MMWR Morb Mortal Wkly Rep ; 71(9): 347-351, 2022 Mar 04.
Article in English | MEDLINE | ID: covidwho-1727016

ABSTRACT

As of February 20, 2022, only BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine has been authorized for use in persons aged 12-17 years in the United States (1). The Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine on December 9, 2021, to authorize a homologous* booster dose for persons aged 16-17 years ≥6 months after receipt of dose 2 (1). On January 3, 2022, authorization was expanded to include persons aged 12-15 years, and for all persons aged ≥12 years, the interval between dose 2 and booster dose was shortened to ≥5 months (1). To characterize the safety of Pfizer-BioNTech booster doses among persons aged 12-17 years (adolescents), CDC reviewed adverse events and health impact assessments during the week after receipt of a homologous Pfizer-BioNTech booster dose reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. During December 9, 2021-February 20, 2022, approximately 2.8 million U.S. adolescents received a Pfizer-BioNTech booster dose.† During this period, receipt of 3,418 Pfizer-BioNTech booster doses were reported to v-safe for adolescents. Reactions were reported to v-safe with equal or slightly higher frequency after receipt of a booster dose than after dose 2, were primarily mild to moderate in severity, and were most frequently reported the day after vaccination. VAERS received 914 reports of adverse events after Pfizer-BioNTech booster dose vaccination of adolescents; 837 (91.6%) were nonserious and 77 (8.4%) were serious. Health care providers, parents, and adolescents should be advised that local and systemic reactions are expected among adolescents after homologous Pfizer-BioNTech booster vaccination, and that serious adverse events are rare.


Subject(s)
Adverse Drug Reaction Reporting Systems , COVID-19 Vaccines/administration & dosage , Adolescent , COVID-19 Vaccines/adverse effects , Child , Female , Humans , Immunization, Secondary/adverse effects , Male , Patient Safety , United States
8.
Front Public Health ; 9: 756633, 2021.
Article in English | MEDLINE | ID: covidwho-1703359

ABSTRACT

Introduction: This study aims to provide a risk assessment of the adverse reactions related to the COVID-19 vaccines manufactured by AstraZeneca, Janssen, Moderna, and Pfizer-BioNTech which have been in use in the European Union and the United States between December 2020 and October 2021. Methods: Data from the European Database of Suspected Adverse Drug Reaction (EudraVigilance) and the Vaccine Adverse Events Reporting System (VAERS) from 2020 to October 2021 are analysed. More than 7.8 million adverse reactions of about 1.6 million persons are included. The adverse reactions are classified with the Common Toxicity Criteria (CTC) categories. COVID-19 vaccine exposures and adverse reactions reported between December 2020 and October 2021 are compared to influenza vaccine exposures and adverse reactions reported between 2020 and 2021. The population-level vaccine exposures to COVID-19 and influenza vaccines comprised about 451 million and 437 million exposures, respectively. Absolute and relative risk estimates are calculated by CTC categories and COVID-19 vaccines for the EU and US populations aged 18 years and older. Results: A higher risk of reporting serious adverse reactions was observed for the COVID-19 vaccines in comparison to the influenza vaccines. Individuals age 65 and older were associated with a higher frequency of death, hospitalisations, and life-threatening reactions than younger individuals (relative risk estimates between 1.49 99% CI [1.44-1.55] and 8.61 99% CI [8.02-9.23]). Outcome onset of serious adverse reactions occurred within the first 7 days after vaccination in about 77.6-89.1% of cases. The largest absolute risks were observed for allergic, constitutional reactions, dermatological, gastrointestinal, neurological reactions, and localised and non-localised pain. The largest relative risks between COVID-19 vs. influenza vaccines were observed for allergic reactions, arrhythmia, general cardiovascular events, coagulation, haemorrhages, gastrointestinal, ocular, sexual organs reactions, and thrombosis. Conclusion: The present study provides an overview of adverse reactions frequently reported to the pharmacovigilance systems following COVID-19 vaccination in the EU and US populations. Despite the limitations of passive reporting systems, these results may inform further clinical research investigating in more detail the pathophysiological mechanisms potentially associated with the COVID-19 vaccines.


Subject(s)
COVID-19 , Influenza Vaccines , Adolescent , Adverse Drug Reaction Reporting Systems , Aged , COVID-19 Vaccines , European Union , Humans , Influenza Vaccines/adverse effects , Pharmacovigilance , SARS-CoV-2 , United States/epidemiology
9.
MMWR Morb Mortal Wkly Rep ; 71(7): 249-254, 2022 Feb 18.
Article in English | MEDLINE | ID: covidwho-1689714

ABSTRACT

During September 22, 2021-February 6, 2022, approximately 82.6 million U.S. residents aged ≥18 years received a COVID-19 vaccine booster dose.* The Food and Drug Administration (FDA) has authorized a booster dose of either the same product administered for the primary series (homologous) or a booster dose that differs from the product administered for the primary series (heterologous). These booster authorizations apply to all three COVID-19 vaccines used in the United States (1-3).† The Advisory Committee on Immunization Practices (ACIP) recommended preferential use of an mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer-BioNTech]) for a booster, even for persons who received the Ad26.COV2.S (Janssen [Johnson & Johnson]) COVID-19 vaccine for their single-dose primary series.§ To characterize the safety of COVID-19 vaccine boosters among persons aged ≥18 years during September 22, 2021-February 6, 2022, CDC reviewed adverse events and health impact assessments following receipt of a booster that were reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. Among 721,562 v-safe registrants aged ≥18 years who reported receiving a booster, 88.8% received homologous COVID-19 mRNA vaccination. Among registrants who reported a homologous COVID-19 mRNA booster dose, systemic reactions were less frequent following the booster (58.4% [Pfizer-BioNTech] and 64.4% [Moderna], respectively) than were those following dose 2 (66.7% and 78.4%, respectively). The adjusted odds of reporting a systemic reaction were higher following a Moderna COVID-19 vaccine booster, irrespective of the vaccine received for the primary series. VAERS has received 39,286 reports of adverse events after a COVID-19 mRNA booster vaccination for adults aged ≥18 years, including 36,282 (92.4%) nonserious and 3,004 (7.6%) serious events. Vaccination providers should educate patients that local and systemic reactions are expected following a homologous COVID-19 mRNA vaccine booster; however, these reactions appear less common than those following dose 2 of an mRNA-based vaccine. CDC and FDA will continue to monitor vaccine safety and provide data to guide vaccine recommendations and protect public health.


Subject(s)
Adverse Drug Reaction Reporting Systems , COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Safety , Adult , Aged , COVID-19 Vaccines/adverse effects , Female , Humans , Immunization, Secondary/adverse effects , Male , Middle Aged , SARS-CoV-2/immunology , United States
11.
MMWR Morb Mortal Wkly Rep ; 71(3): 90-95, 2022 Jan 21.
Article in English | MEDLINE | ID: covidwho-1636128

ABSTRACT

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use as a single-dose primary vaccination in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS), a rare condition characterized by low platelets and thrombosis, including at unusual sites such as the cerebral venous sinus (cerebral venous sinus thrombosis [CVST]), after receipt of the vaccine.* ACIP rapidly convened two emergency meetings to review reported cases of TTS, and 10 days after the pause commenced, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in persons aged ≥18 years, but included a warning regarding rare clotting events after vaccination, primarily among women aged 18-49 years (3). In July, after review of an updated benefit-risk assessment accounting for risks of Guillain-Barré syndrome (GBS) and TTS, ACIP concluded that benefits of vaccination with Janssen COVID-19 vaccine outweighed risks. Through ongoing safety surveillance and review of reports from the Vaccine Adverse Event Reporting System (VAERS), additional cases of TTS after receipt of Janssen COVID-19 vaccine, including deaths, were identified. On December 16, 2021, ACIP held an emergency meeting to review updated data on TTS and an updated benefit-risk assessment. At that meeting, ACIP made a recommendation for preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine, including both primary and booster doses administered to prevent COVID-19, for all persons aged ≥18 years. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines.


Subject(s)
/adverse effects , Advisory Committees , COVID-19 Vaccines/therapeutic use , Thrombocytopenia/chemically induced , Vaccination/standards , Adult , Adverse Drug Reaction Reporting Systems , Aged , COVID-19/prevention & control , Centers for Disease Control and Prevention, U.S. , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Male , Middle Aged , Risk Assessment , SARS-CoV-2/immunology , United States/epidemiology
12.
Elife ; 102021 11 23.
Article in English | MEDLINE | ID: covidwho-1622815

ABSTRACT

Background: Potential therapy and confounding factors including typical co-administered medications, patient's disease states, disease prevalence, patient demographics, medical histories, and reasons for prescribing a drug often are incomplete, conflicting, missing, or uncharacterized in spontaneous adverse drug event (ADE) reporting systems. These missing or incomplete features can affect and limit the application of quantitative methods in pharmacovigilance for meta-analyses of data during randomized clinical trials. Methods: Data from patients with hypertension were retrieved and integrated from the FDA Adverse Event Reporting System; 134 antihypertensive drugs out of 1131 drugs were filtered and then evaluated using the empirical Bayes geometric mean (EBGM) of the posterior distribution to build ADE-drug profiles with an emphasis on the pulmonary ADEs. Afterward, the graphical least absolute shrinkage and selection operator (GLASSO) captured drug associations based on pulmonary ADEs by correcting hidden factors and confounder misclassification. Selected drugs were then compared using the Friedman test in drug classes and clusters obtained from GLASSO. Results: Following multiple filtering stages to exclude insignificant and noise-driven reports, we found that drugs from antihypertensives agents, urologicals, and antithrombotic agents (macitentan, bosentan, epoprostenol, selexipag, sildenafil, tadalafil, and beraprost) form a similar class with a significantly higher incidence of pulmonary ADEs. Macitentan and bosentan were associated with 64% and 56% of pulmonary ADEs, respectively. Because these two medications are prescribed in diseases affecting pulmonary function and may be likely to emerge among the highest reported pulmonary ADEs, in fact, they serve to validate the methods utilized here. Conversely, doxazosin and rilmenidine were found to have the least pulmonary ADEs in selected drugs from hypertension patients. Nifedipine and candesartan were also found by signal detection methods to form a drug cluster, shown by several studies an effective combination of these drugs on lowering blood pressure and appeared an improved side effect profile in comparison with single-agent monotherapy. Conclusions: We consider pulmonary ADE profiles in multiple long-standing groups of therapeutics including antihypertensive agents, antithrombotic agents, beta-blocking agents, calcium channel blockers, or agents acting on the renin-angiotensin system, in patients with hypertension associated with high risk for coronavirus disease 2019 (COVID-19). We found that several individual drugs have significant differences between their drug classes and compared to other drug classes. For instance, macitentan and bosentan from endothelin receptor antagonists show major concern while doxazosin and rilmenidine exhibited the least pulmonary ADEs compared to the outcomes of other drugs. Using techniques in this study, we assessed and confirmed the hypothesis that drugs from the same drug class could have very different pulmonary ADE profiles affecting outcomes in acute respiratory illness. Funding: GJW and MJD accepted funding from BioNexus KC for funding on this project, but BioNexus KC had no direct role in this article.


Subject(s)
Antihypertensive Agents/adverse effects , COVID-19/complications , Data Mining/methods , Drug-Related Side Effects and Adverse Reactions , Hypertension/drug therapy , Pharmacovigilance , Adverse Drug Reaction Reporting Systems , Angiotensin-Converting Enzyme Inhibitors/adverse effects , Antihypertensive Agents/therapeutic use , Bayes Theorem , Calcium Channel Blockers/adverse effects , Fibrinolytic Agents/adverse effects , Humans , Hypertension/complications , SARS-CoV-2
13.
Curr Probl Cardiol ; 47(3): 101077, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1561331

ABSTRACT

Given the urgent need to control the spread of the novel COVID-19 virus, 13 vaccines have been approved for emergency use before completing all 3 phases of the clinical trials. Thereby a careful monitor of the adverse effects postvaccination is essential. We searched through PubMed and other reporting systems like VAERS for the reported cardiovascular adverse events post-COVID-19 vaccination. Through our review, we determined that the incidence of all the reported cardiovascular events is very rare. Additionally, the vaccine was initially given to the elderly and high-risk populations in which cardiovascular events such as myocardial infarction and arrhythmias are already more prevalent, while other cardiovascular events such as myocarditis or vaccine-induced thrombotic thrombocytopenia were more common in younger populations. Moreover, a direct causal relationship, if any, between vaccination and adverse events is yet to be fully elucidated. Thus, at this time point, the benefits of vaccination far outweigh the risk.


Subject(s)
COVID-19 Vaccines , Vaccination , Adverse Drug Reaction Reporting Systems , Aged , COVID-19 , COVID-19 Vaccines/adverse effects , Humans , SARS-CoV-2 , Vaccination/adverse effects
16.
Cad. Saúde Pública (Online) ; 37(10): e00077721, 2021. tab
Article in English | WHO COVID, LILACS (Americas) | ID: covidwho-1523494

ABSTRACT

Abstract: The U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events. The available information on the renal safety profile for remdesivir is limited, thus we analyzed the renal and urinary adverse reactions attributed to remdesivir reported in a large open pharmacovigilance database. We obtained reports of remdesivir and other drugs used to treat COVID-19 (tocilizumab, hydroxychloroquine, lopinavir/ritonavir) registered by September 30 2020, from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed the reporting odds ratios (RORs) for reports of adverse renal and urinary events for remdesivir and other drugs. We found 2,922 reports with remdesivir registered in FAERS for COVID-19. Among these, 493 renal and urinary adverse effects (16.9%) were reported. The most frequent events were acute kidney injury (338; 11.6%), renal impairment (86; 2.9%), and renal failure (53; 1.8%). Versus hydroxychloroquine, lopinavir/ritonavir, or tocilizumab, the use of remdesivir was associated with an increased chance of reporting renal and urinary disorders regardless of gender and age of patients (2.53; 95%CI: 2.10-3.06). The ROR remained significant when we restricted the analysis to hydroxychloroquine (4.31; 95%CI: 3.25-5.71) or tocilizumab (3.92; 95%CI: 2.51-6.12). Our results reinforce this already reported signal, emphasizing that it could be extremely useful for health professionals who prescribe this new antiviral to treat COVID-19, mainly knowing its low efficacy.


Resumo: De acordo com a Agência de Controle de Alimentos e Medicamentos dos Estados Unidos (FDA), a prescrição do remdesivir deve ser feita com cautela em pacientes com taxa de filtração glomerular estimada (TFGe) < 30, sendo que diversos estudos relatam risco de eventos adversos renais. São limitados os dados disponíveis sobre o perfil de segurança renal do remdesivir. Assim, analisamos as reações adversas renais e urinárias atribuídas ao remdesivir e notificadas em um grande base de dados abertos de farmacovigilância. Obtivemos notificações sobre remdesivir e outros medicamentos usados para tratar a COVID-19 (tocilizumabe, hidroxicloroquina, lopinavir/ritonavir) registradas até 30 de setembro de 2020 do Sistema de Notificação de Eventos Adversos da FDA (FAERS). Analisamos as razões de chances de notificação (RORs) para notificações de eventos adversos renais e urinários referentes ao remdesivir e outros medicamentos. Encontramos 2.922 notificações sobre remdesivir registradas no FAERS para COVID-19. Entre esses casos, foram notificados 493 efeitos adversos renais e urinários (16,9%). Os eventos mais frequentes foram lesão renal aguda (338; 11,6%), comprometimento renal (86; 2,9%) e insuficiência renal (53; 1,8%). Comparado com a hidroxicloroquina, lopinavir/ritonavir ou tocilizumabe, o uso do remdesivir esteve associado com um aumento das chances de notificação de transtornos renais e urinários, independentemente do sexo e idade dos pacientes (2,53; IC95%: 2,10-3,06). A ROR permaneceu significativo quando limitamos a análise à hidroxicloroquina (4,31; IC95%: 3,25-5,71) ou ao tocilizumabe (3,92; IC95%: 2,51-6,12). Nossos resultados corroboram outros estudos e destacam a utilidade para profissionais da saúde que usam esse novo antiviral para tratar a COVID-19, sobretudo em função de sua baixa eficácia.


Resumen: La Agencia Americana de Control de Alimentos y Medicamentos (FDA) ha destacado que la prescripción de remdesivir debe ser prudente con pacientes con tasa de filtración glomerular estimada (TGFe) < 30; además, algunos estudios informaron del riesgo de reacciones adversas renales. La información disponible sobre el perfil de seguridad renal, en el caso del remdesivir, es limitada. Por ello, analizamos las reacciones adversas renales y urinarias atribuidas al remdesivir e notificadas en una extensa base de datos abierta de farmacovigilancia. Obtuvimos las notificaciones de remdesivir y otros medicamentos usados para tratar la COVID-19 (tocilizumab, hidroxicloroquina, lopinavir/ritonavir) registrados el 30 de septiembre de 2020 por el Sistema de Notificación de Eventos Adversos de la FDA (FAERS). Analizamos las odds ratios informadas (RORs) en el caso de informes de eventos adversos renales y urinarios adversos relacionados con el remdesivir y otros medicamentos. En el FAERS, encontramos 2.922 notificaciones de remdesivir registradas como medicament sospechoso usado en COVID-19. De estos, habían 493 con efectos renales y urinarios adversos (16,9%). Los efectos adversos más frecuentes fueron lesiones renales agudas (338; 11,6%), insuficiencia renal (86; 2,9%), y fallo renal (53; 1,8%). Frente a hidroxicloroquina, lopinavir/ritonavir, o tocilizumab, el uso de remdesivir se asoció con un riesgo mayor de notificar alteraciones renales y urinarios, independientemente del género y edad de los pacientes (2,53; IC95%: 2,10-3,06). La ROR permaneció significativo al restringir el análisis a la hidroxicloroquina (4,31; IC95%: 3,25-5,71) o tocilizumab (3,92; IC95%: 2,51-6,12). Nuestros resultados corroboran datos previos, algo que podría ser extremadamente útil para los profesionales de la salud que decidan usar este nuevo antiviral para tratar la COVID-19, sobre todo conociendo su baja eficacia.


Subject(s)
Humans , Pharmacovigilance , COVID-19/drug therapy , Brazil , Adenosine Monophosphate/analogs & derivatives , Adverse Drug Reaction Reporting Systems , Alanine/analogs & derivatives , SARS-CoV-2 , Kidney
17.
Acta Biomed ; 92(S6): e2021487, 2021 10 19.
Article in English | MEDLINE | ID: covidwho-1503980

ABSTRACT

BACKGROUND AND AIM: The urgency of having rapidly safe and efficient COVID-19 vaccines called for the need to shorten trial phases, reduce sample sizes, and speed-up the approval process by the regulatory Agencies. In light of this, monitoring adverse effects (AEFI) (both immediate and at medium-long term) become of great importance. Aim of this cross-sectional study was to explore the associations between several factors and risk of immediate AEFI. METHODS: Data come from the electronic dataset developed ad hoc to record demographic data, anamnesis and data related to immunization, set-up in the mass vaccination site in Novegro (Milan). Novegro mass vaccination site was one of the mass vaccinations sites with the highest flow in Lombardy Region, with a maximum capacity of 5,000 vaccinations/day. The center opened in April 2021 and closed the 1st of August 2021. A multivariable logistic regression model was used. Odds ratios adjusted (aOR) for age and sex are presented. Statistical significance was set at p<0.05. Analyses were conducting using STATA. RESULTS: Among the total of 314,671 subjects vaccinated, 0.5% developed an immediate AEFI, on average 17.0 ± 0.43 minutes after the administration. The three most frequent AEFI recorded were vagal response (30%), anxiety reaction (24%) and dizziness (21%). AEFI were more frequently observed among women [aOR= 2.24 (95%CI= 2.00 - 2.50)], and those with at least one previous disease [aOR= 1.47 (95%CI= 1.22-1.76)]. CONCLUSIONS: In conclusion, AEFI were less likely to occur for increasing age and after the second dose. Results from this large, complete and representative sample population regarding enrich the interesting scientific debate on potential adverse events following COVID-19 immunization.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19 , Vaccination , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , Cross-Sectional Studies , Female , Humans , Immunization , Italy/epidemiology , Male , Vaccination/adverse effects
18.
MMWR Morb Mortal Wkly Rep ; 70(44): 1545-1552, 2021 Nov 05.
Article in English | MEDLINE | ID: covidwho-1502902

ABSTRACT

Three COVID-19 vaccines are currently approved under a Biologics License Application (BLA) or authorized under an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) and recommended for primary vaccination by the Advisory Committee on Immunization Practices (ACIP) in the United States: the 2-dose mRNA-based Pfizer-BioNTech/Comirnaty and Moderna COVID-19 vaccines and the single-dose adenovirus vector-based Janssen (Johnson & Johnson) COVID-19 vaccine (1,2) (Box 1). In August 2021, FDA amended the EUAs for the two mRNA COVID-19 vaccines to allow for an additional primary dose in certain immunocompromised recipients of an initial mRNA COVID-19 vaccination series (1). During September-October 2021, FDA amended the EUAs to allow for a COVID-19 vaccine booster dose following a primary mRNA COVID-19 vaccination series in certain recipients aged ≥18 years who are at increased risk for serious complications of COVID-19 or exposure to SARS-CoV-2 (the virus that causes COVID-19), as well as in recipients aged ≥18 years of Janssen COVID-19 vaccine (1) (Table). For the purposes of these recommendations, an additional primary (hereafter additional) dose refers to a dose of vaccine administered to persons who likely did not mount a protective immune response after initial vaccination. A booster dose refers to a dose of vaccine administered to enhance or restore protection by the primary vaccination, which might have waned over time. Health care professionals play a critical role in COVID-19 vaccination efforts, including for primary, additional, and booster vaccination, particularly to protect patients who are at increased risk for severe illness and death.


Subject(s)
Advisory Committees , COVID-19 Vaccines/administration & dosage , Immunization/standards , Practice Guidelines as Topic , Adolescent , Adult , Adverse Drug Reaction Reporting Systems , Aged , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Centers for Disease Control and Prevention, U.S. , Drug Approval , Humans , Middle Aged , United States/epidemiology , United States Food and Drug Administration , Young Adult
19.
Med Sci Monit ; 27: e935299, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1497922

ABSTRACT

Healthcare professionals have an ethical, medico-legal, and professional responsibility to report all suspected adverse events following immunization to relevant national reporting agencies as part of the process of post-marketing drug safety monitoring. In the US, the Vaccine Adverse Event Reporting System (VAERS) is co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Data from VAERS and other national and global reporting systems show very low rates of adverse events related to currently approved SARS-CoV-2 vaccines. Populations studies have supported the findings from adverse event reporting systems. The presentation, monitoring, and reporting of adverse events related to SARS-CoV-2 vaccines may have future applications in vaccine monitoring for several other potential pandemic zoonotic infections. This editorial aims to summarize the current understanding of adverse events from current COVID-19 vaccines from global adverse event reporting systems, rather than individual case reports or anecdotal reporting in the media.


Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , COVID-19 Vaccines/adverse effects , COVID-19/drug therapy , SARS-CoV-2/drug effects , Vaccination/adverse effects , COVID-19/immunology , COVID-19/virology , Humans , International Agencies
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