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Mining and updating the post-marketing safety signals of esketamine nasal spray for better identification of adverse drug event (ADE) signals and medication monitoring during clinical use to ensure patient medication safety. Downloading data from the US Food and Drug Administration Adverse Event Reporting System from Q1 2019 to Q2 2023, the reporting odds ratio, proportional reporting ratio, Multi-item Gamma Poisson Shrinker, and Bayesian Confidence Propagation Neural Network methods of the disproportionality method were used to mine and analyze ADEs, and finally to screen for signals of ADEs with esketamine nasal spray as the primary suspected drug. The Preferred Terminology of the Medical Dictionary of Regulatory Activities (version 26.0) was used to standardize the description of ADEs and to attribute ADEs to the System Organ Classification. A total of 5132 ADEs reports of esketamine nasal spray as the primary suspected drug were obtained from the Food and Drug Administration Adverse Event Reporting System. The most frequently observed ADEs are dissociation, sedation, and hypertension, while some new rare signals have been detected, such as interstitial cystitis, substance abuse, and drug diversion. The present study identified significant new ADEs signals for esketamine nasal spray, which may provide a source for healthcare professionals to assess patients' symptoms and risk identification.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Ketamina , Rociadores Nasales , Farmacovigilancia , Humanos , Ketamina/efectos adversos , Ketamina/administración & dosificación , Estados Unidos , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Masculino , Adulto , Femenino , Persona de Mediana Edad , United States Food and Drug Administration , Teorema de Bayes , Adolescente , Adulto JovenAsunto(s)
Vigilancia de Productos Comercializados , Humanos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Medición de Riesgo , Farmacoepidemiología , Sistemas de Registro de Reacción Adversa a Medicamentos/legislación & jurisprudencia , United States Food and Drug Administration , Estados UnidosRESUMEN
Prior research has indicated that bisphosphonates (BPs) can improve periodontal disease because of their anti-osteoporosis properties. In vitro studies have shown that BPs induce cytotoxicity, inhibit wound healing, and thus affect periodontal disease. Denosumab and BPs have alternative indications. BP and denosumab are not known to correlate with gingival disorders. We assessed such a relationship by applying Bayesian and nonproportional analyses to data in the US FDA Adverse Event Reporting System (FAERS) database. The study analyzed BPs and denosumab-reported incidents with preferred terms found in the narrow Standardized MedDRA Queries for gingival disorders. A total of 5863 reported cases of gingival disorders were associated with five BPs (alendronate, pamidronate, ibandronate, risedronate, and zoledronate) and denosumab. More than 15% of patients with gingival disorders related to BPs and denosumab other than denosumab were hospitalized over short- or long-term periods. Our findings indicated BPs and denosumab had significant reporting odds ratios (ROR), proportional reporting ratios (PRR), and information components (IC) with respect to gingival disorders. Pamidronate had the highest association (ROR = 64.58, PRR = 57.99, IC = 5.71), while the weakest association was found with denosumab (ROR = 3.61, PRR = 3.60, IC = 1.77). Significant associations were found between the six drugs and gingival pain, gingival recession, gingivitis, periodontal disease, and periodontitis. In conclusion, our comprehensive overview of the correlations, clinical characteristics, and prognoses of BPs and denosumab-related gingival disorders suggests that these issues deserve continued surveillance and appropriate management.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Denosumab , Difosfonatos , Enfermedades de las Encías , United States Food and Drug Administration , Humanos , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Estados Unidos/epidemiología , Difosfonatos/efectos adversos , Denosumab/efectos adversos , Enfermedades de las Encías/inducido químicamente , Enfermedades de las Encías/epidemiología , Femenino , Conservadores de la Densidad Ósea/efectos adversos , Masculino , Persona de Mediana Edad , AncianoRESUMEN
INTRODUCTION: Beehive products are widely used in food supplements; however, their composition variability and allergenic components have raised some concerns. This work aims to provide information about the beehive products safety profile by evaluating the suspected adverse reactions (ARs). METHODS: The suspected report of ARs collected within the Italian Phytovigilance System (IPS) were evaluated. The clinical and demographic characteristics of the cases were described, and the causality assessment performed. RESULTS: 61 reports were analysed, mainly concerned women. Serious events were reported in 17 forms (28%). The ARs (n=116) referred to respiratory (25.0%), skin (24.1%), and gastrointestinal disorders (21.5%). Label warnings for atopic subjects were present only in 7 food supplements. The causality assessment was mostly probable (54.1%). CONCLUSIONS: Present findings outline relevant information about the safety issues of beehive product consumption, especially in atopic or allergic subjects, and strengthen the importance of IPS to point out safety signals.
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Suplementos Dietéticos , Humanos , Suplementos Dietéticos/efectos adversos , Italia , Femenino , Masculino , Persona de Mediana Edad , Adulto , Anciano , Adulto Joven , Adolescente , Farmacovigilancia , Sistemas de Registro de Reacción Adversa a Medicamentos , Alérgenos/efectos adversos , NiñoRESUMEN
Background: Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) that has been approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma (UC). This study presents a comprehensive pharmacovigilance analysis of the post-marketing safety profile of EV in the real-world based on the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Adverse event (AE) reports regarding EV between January 2020 and December 2023 were obtained from the FAERS database. The standardized MedDRA query (SMQ) narrow search AEs on the preferred term (PT) level were used. Disproportionality analysis was performed to identify the AE signals for EV with the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN). Results: A total of 2,216 reports regarding EV were included in the present study. SMQ analysis results indicated that a stronger strength signal was found in severe cutaneous adverse reactions, retroperitoneal fibrosis, and peripheral neuropathy. A total of 116 significant disproportionality PTs referring to 14 system organ classes (SOCs) were retained by disproportionality analysis, with 49 PTs not listed on the EV drug label. Frequently reported EV-related AEs included rash, peripheral neuropathy, decreased appetite, alopecia, and pruritus. The time to onset of the majority of EV-related AEs was within 30 days (66.05%), with only 0.73% events occurring after 1 year. Conclusion: The disproportionality analysis highlights that dermatologic toxicity and peripheral neuropathy were the major AEs induced by EV. The potential AEs not listed on the drug label were mainly related to gastrointestinal, hepatic, and pulmonary events. Further research is needed to confirm and explore the EV-related AEs in clinical practice.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Bases de Datos Factuales , Farmacovigilancia , Vigilancia de Productos Comercializados , Humanos , Masculino , Femenino , Anciano , Persona de Mediana Edad , Adulto , Estados Unidos/epidemiología , Inmunoconjugados/efectos adversos , Adulto Joven , Anticuerpos Monoclonales/efectos adversos , Adolescente , Anciano de 80 o más Años , United States Food and Drug Administration , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiologíaRESUMEN
BACKGROUND: Adverse drug events pose an enormous public health burden, leading to hospitalization, disability, and death. Even the adverse events (AEs) categorized as nonserious can severely impact on patient's quality of life, adherence, and persistence. Monitoring medication safety is challenging. Web-based patient reports on social media may be a useful supplementary source of real-world data. Despite the growth of sophisticated techniques for identifying AEs using social media data, a consensus has not been reached as to the value of social media in relation to more traditional data sources. OBJECTIVE: This study aims to evaluate and characterize the utility of social media analysis in adverse drug event detection and pharmacovigilance as compared with other data sources (such as spontaneous reporting systems and the clinical literature). METHODS: In this scoping review, we searched 11 bibliographical databases and Google Scholar, followed by handsearching and forward and backward citation searching. Each record was screened by 2 independent reviewers at both the title and abstract stage and the full-text screening stage. Studies were included if they used any type of social media (such as Twitter or patient forums) to detect AEs associated with any drug medication and compared the results ascertained from social media to any other data source. Study information was collated using a piloted data extraction sheet. Data were extracted on the AEs and drugs searched for and included; the methods used (such as machine learning); social media data source; volume of data analyzed; limitations of the methodology; availability of data and code; comparison data source and comparison methods; results, including the volume of AEs, and how the AEs found compared with other data sources in their seriousness, frequencies, and expectedness or novelty (new vs known knowledge); and conclusions. RESULTS: Of the 6538 unique records screened, 73 publications representing 60 studies with a wide variety of extraction methods met our inclusion criteria. The most common social media platforms used were Twitter and online health forums. The most common comparator data source was spontaneous reporting systems, although other comparisons were also made, such as with scientific literature and product labels. Although similar patterns of AE reporting tended to be identified, the frequencies were lower in social media. Social media data were found to be useful in identifying new or unexpected AEs and in identifying AEs in a timelier manner. CONCLUSIONS: There is a large body of research comparing AEs from social media to other sources. Most studies advocate the use of social media as an adjunct to traditional data sources. Some studies also indicate the value of social media in understanding patient perspectives such as the impact of AEs, which could be better explored. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/47068.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Farmacovigilancia , Medios de Comunicación Sociales , Medios de Comunicación Sociales/estadística & datos numéricos , Humanos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricosRESUMEN
BACKGROUND: Despite Africa's significant infectious disease burden, it is underrepresented in global vaccine clinical trials. While this trend is slowly reversing, it is important to recognize and mitigate the challenges that arise when conducting vaccine clinical trials in this environment. These challenges stem from a variety of factors peculiar to the population and may negatively impact adverse event collection and reporting if not properly addressed. METHODS: As a team of clinical researchers working within the MRCG (Medical Research Council Unit The Gambia), we have conducted 12 phase 1 to 3 vaccine trials over the past 10 years. In this article, we discuss the challenges we face and the strategies we have developed to improve the collection and reporting of adverse events in low-income settings. OUTCOME: Healthcare-seeking behaviors in the Gambia are influenced by spiritual and cultural beliefs as well as barriers to accessing orthodox healthcare; participants in trials may resort to non-orthodox care, reducing the accuracy of reported adverse events. To address this, trial eligibility criteria prohibit self-treatment and herbal product use during trials. Instead, round-the-clock care is provided to trial participants, facilitating safety follow-up. Constraints in the healthcare system in the Gambia such as limitations in diagnostic tools limit the specificity of diagnosis when reporting adverse events. To overcome these challenges, the Medical Research Council Unit maintains a Clinical Services Department, offering medical care and diagnostic services to study participants. Sociocultural factors, including low literacy rates and social influences, impact adverse event collection. Solicited adverse events are collected during home visits on paper-based or electronic report forms. Community engagement meetings are held before each study starts to inform community stakeholders about the study and answer any questions they may have. These meetings ensure that influential members of the community understand the purpose of the study and the risks and benefits of participating in the trial. This understanding makes them more likely to support participation within their communities. CONCLUSION: Conducting ethical vaccine clinical trials in resource-limited settings requires strategies to accurately collect and report adverse events. Our experiences from the Gambia offer insights into adverse event collection in these settings.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Pobreza , Vacunas , Humanos , Gambia , Vacunas/efectos adversos , Vacunas/administración & dosificación , Ensayos Clínicos como Asunto , Proyectos de Investigación , Seguridad del Paciente , Características Culturales , Conocimientos, Actitudes y Práctica en Salud , Aceptación de la Atención de Salud , Sujetos de Investigación/psicología , Factores de Riesgo , Países en DesarrolloAsunto(s)
United States Food and Drug Administration , Humanos , Estados Unidos/epidemiología , Estudios Transversales , Masculino , Femenino , Persona de Mediana Edad , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/administración & dosificación , Péptido 1 Similar al Glucagón/agonistas , Péptido 1 Similar al Glucagón/efectos adversos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Receptor del Péptido 1 Similar al Glucagón/agonistas , Anciano , Liraglutida/efectos adversos , Liraglutida/uso terapéutico , Exenatida/efectos adversos , Exenatida/administración & dosificación , Adulto , Erupciones por Medicamentos/etiología , Erupciones por Medicamentos/epidemiologíaRESUMEN
This study aimed to evaluate the association between sacubitril/valsartan and dementia-related adverse events (AEs) in geographical subpopulations using subgroup disproportionality analysis. Cases from the FDA adverse event reporting system involving patients aged 60 or older with sacubitril/valsartan or angiotensin receptor blockers (ARBs) were analyzed. The adjusted reporting odds ratios (RORs) for dementia-related AEs were calculated for each continent. A total of 61,518 AEs associated with sacubitril/valsartan or ARBs were identified. Among these, 1441 were dementia-related AEs. In Asia, Europe, and Africa, the reporting risk of dementia-related AEs associated with sacubitril/valsartan was lower compared to ARBs (adjusted ROR, 0.57 [95% CI 0.31-1.01]; adjusted ROR, 0.89 [95% CI 0.69-1.14]; adjusted ROR, 0.40 [95% CI 0.27-0.61], respectively). In Latin America and Oceania, the reporting risk of dementia-related AEs associated with sacubitril/valsartan was similar to that associated with ARBs (adjusted ROR, 1.04 [95% CI 0.75-1.44]; adjusted ROR, 1.02 [95% CI 0.31-3.37], respectively). On the contrary, in North America, the reporting risk associated with sacubitril/valsartan was higher compared to ARBs (adjusted ROR, 1.29 [95% CI 1.10-1.53]). Although the ROR value did not meet the criteria for signal detection, the significantly greater than 1 ROR observed in North America suggests that caution may be warranted regarding potential dementia-related adverse events associated with sacubitril/valsartan.
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Aminobutiratos , Antagonistas de Receptores de Angiotensina , Compuestos de Bifenilo , Demencia , Combinación de Medicamentos , Valsartán , Humanos , Valsartán/efectos adversos , Aminobutiratos/efectos adversos , Compuestos de Bifenilo/efectos adversos , Demencia/epidemiología , Demencia/inducido químicamente , Masculino , Femenino , Anciano , Antagonistas de Receptores de Angiotensina/efectos adversos , Persona de Mediana Edad , Anciano de 80 o más Años , Tetrazoles/efectos adversos , Sistemas de Registro de Reacción Adversa a Medicamentos , Estados Unidos/epidemiologíaRESUMEN
Acute kidney injury (AKI) due to vitamin D therapy for osteoporosis is encountered in clinical practice, but epidemiological studies are scarce. We aimed to determine the association between AKI and vitamin D therapy and to identify risk factors for AKI using the Japanese Adverse Drug Event Report database. We used reporting odds ratios (RORs) to detect signals and evaluate risk factors using multiple logistic regression analysis. Among 298,891 reports from April 2004 to September 2023, 1071 implicated active vitamin D3 analogs as suspect drugs for adverse events. There was a significant association between AKI and active vitamin D3 analogs (ROR [95% confidence interval {CI}], eldecalcitol: 16.75 [14.23-19.72], P < 0.001; alfacalcidol: 5.29 [4.07-6.87], P < 0.001; calcitriol: 4.46 [1.88-10.59], P < 0.001). The median duration of administration before AKI onset was 15.4 weeks. Multiple logistic regression analysis showed a significant association between AKI and age ≥ 70 years (odds ratio [95% CI], 1.47 [1.04-2.07]; P = 0.028), weight < 50 kg (1.55 [1.12-2.13]; P = 0.007), hypertension (1.90 [1.42-2.54]; P < 0.001), and concomitant use of nonsteroidal anti-inflammatory drugs (1.58 [1.10-2.25], P = 0.012) and magnesium oxide (1.96 [1.38-2.78]; P < 0.001). Our results suggest that active vitamin D3 analogs are associated with AKI development. Physicians prescribing these medications to patients with risk factors should consider the possibility of AKI, especially during the first 6 months.
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Lesión Renal Aguda , Sistemas de Registro de Reacción Adversa a Medicamentos , Colecalciferol , Bases de Datos Factuales , Farmacovigilancia , Humanos , Lesión Renal Aguda/inducido químicamente , Lesión Renal Aguda/epidemiología , Femenino , Masculino , Anciano , Japón/epidemiología , Persona de Mediana Edad , Colecalciferol/efectos adversos , Factores de Riesgo , Anciano de 80 o más Años , Osteoporosis/tratamiento farmacológico , Osteoporosis/epidemiología , Adulto , Hidroxicolecalciferoles/efectos adversos , Hidroxicolecalciferoles/uso terapéutico , Pueblos del Este de Asia , Vitamina D/análogos & derivadosRESUMEN
Antibody-drug conjugates (ADCs) are among the fastest-growing classes of anticancer drugs, making it crucial to evaluate their potential for causing peripheral neuropathy. We analyzed data from the FAERS database (January 1, 2014, to June 30, 2023) using disproportionality and Bayesian methods. We identified 3076 cases of ADC-associated peripheral neuropathy. Our study revealed significant signals for all ADCs (ROR 1.82, 95% CI 1.76-1.89). ADCs with tubulin-binding payloads showed significant peripheral neuropathy signals (ROR 2.31, 95% CI 2.23-2.40), whereas those with DNA-targeting (ROR 0.48, 95% CI 0.39-0.59) and topoisomerase 1 inhibitor (ROR 0.56, 95% CI 0.48-0.66) payloads exhibited non-significant signals. Signals for peripheral sensory neuropathy were 4.83, 2.44, 2.74, and 2.21 (calculated based on IC025) for brentuximab vedotin, trastuzumab emtansine, enfortumab vedotin, and polatuzumab vedotin, while signals for peripheral motor neuropathy were 5.31, 0.34, 2.27, and 0.03, respectively. The median time to onset for all ADCs was 127 days (interquartile range 40-457). Tisotumab vedotin had the highest hospitalization rate at 26.67%, followed by brentuximab vedotin at 25.5%. Trastuzumab emtansine had the highest mortality rate ,with 80 deaths (11.96%) among 669 cases. Based on FAERS database, only ADCs with tubulin-binding payloads exhibited significant peripheral neuropathy signals. Brentuximab vedotin and enfortumab vedotin showed similar profiles for peripheral sensory neuropathy and motor neuropathy. Given the delayed time to onset and potentially poor outcomes, ADC-related peripheral neuropathy warrants significant attention.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Inmunoconjugados , Enfermedades del Sistema Nervioso Periférico , Farmacovigilancia , United States Food and Drug Administration , Humanos , Inmunoconjugados/efectos adversos , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/epidemiología , Estados Unidos/epidemiología , Antineoplásicos/efectos adversos , Femenino , Masculino , Teorema de Bayes , Bases de Datos FactualesRESUMEN
BACKGROUND: Immune-related adverse events (irAEs) always occur during treatment with immune checkpoint inhibitors (ICIs). Patients with nervous system cancer (NSC) may gain clinical benefit from ICIs, but irAEs in NSC patients are rarely examined. Therefore, our study systematically summarized reports of irAEs in NSC. METHODS: We obtained information from the FDA adverse event reporting system from the first quarter (Q1) of 2013 to the fourth quarter (Q4) of 2022. We examined use of a combination of ICIs and chemotherapy (ICI_Chemo) or chemotherapy only (ICI_Chemo) for patients with NSC. Multiple disproportionality analyses were applied to assess irAEs. Multiomics data from the gene expression omnibus (GEO) database were analyzed to explore potential molecular mechanisms associated with irAEs in NSC patients. RESULTS: Fourteen irAEs were identified in 8,357 NSC patients after removing duplicates; the top five events were seizure, confused state, encephalopathy, muscular weakness and gait disturbance. Older patients were more likely to develop irAEs than were younger patients. From the start of ICIs_Chemo to irAE occurrence, there was a significant difference in the time to onset of irAEs between age groups. irAEs may occur via mechanisms involving the inflammatory response, secretion of inflammatory mediators, and aberrant activation of pathologic pathways. CONCLUSIONS: This study helps to characterize irAEs in NSC patients treated with ICIs. We combined GEO database analysis to explore the potential molecular mechanisms of irAEs. The results of this study provide a basis for improving the toxic effects of ICIs in NSC patients.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Inhibidores de Puntos de Control Inmunológico , United States Food and Drug Administration , Humanos , Inhibidores de Puntos de Control Inmunológico/efectos adversos , Estados Unidos , Masculino , Persona de Mediana Edad , Femenino , Anciano , Adulto , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Anciano de 80 o más Años , Adulto Joven , AdolescenteRESUMEN
To assess the safety of varicella vaccine (VarV) by conducting post-marketing surveillance on adverse events following immunization (AEFI) in Jiangsu Province, China. METHODS: We utilized the AEFI Information System of mainland China to monitor and categorize adverse reactions associated with VarV. RESULTS: The incidence rate of AEFI was significantly higher after the first dose (48.79/100,000 doses) compared to the second dose (45.18/100,000 doses) (χ2 = 4.63, P = 0.031). Regional variations in AEFI incidence were observed within Jiangsu Province. Common reactions comprised 90.96% of AEFIs, while rare reactions and coincidental events accounted for 6.59% and 0.51%, respectively. Notably, there were no adverse events linked to vaccine quality, program errors, psychogenic reactions, or fatalities. Over 96% of AEFIs occurred within three days of VarV administration, with redness at the injection site (2.6 cm to 5 cm in diameter) being the most frequently observed symptom. CONCLUSION: VarV demonstrates a commendable safety profile. Although there was a slight increase in AEFI incidence between 2022 and 2023, common vaccine reactions were predominantly observed, and the rates of rare reactions remained very low.
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Vacuna contra la Varicela , Varicela , Humanos , Vacuna contra la Varicela/efectos adversos , Vacuna contra la Varicela/administración & dosificación , China/epidemiología , Masculino , Femenino , Lactante , Niño , Preescolar , Incidencia , Varicela/prevención & control , Varicela/epidemiología , Vigilancia de Productos Comercializados , Adolescente , Adulto , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Vacunación/efectos adversos , Adulto Joven , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Persona de Mediana EdadRESUMEN
BACKGROUND: Numerous digestive system adverse events (dsAEs) have been observed during the use of anti-obesity medications (AOMs), leading to concerns about the safety of these medications. However, most current studies are limited to the association of one class of drugs with specific digestive disorders, and there is no cascading analysis of AOMs in the digestive system. This study aims to use data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) for a stratified analysis of the reported associations between AOMs and dsAEs. METHODS: We analyzed adverse event reports submitted to FAERS between January 2015 and December 2023 related to obesity treatment. It is important to note that FAERS data cannot establish causality or incidence rates. Pharmacovigilance (PV) signals were detected by disproportionate analyses through proportionate reporting ratio (PRR), reporting odds ratios (ROR), and information components (IC) to detect dsAEs associated with AOMs. Reporting rates, severity, and response outcomes of digestive adverse events were compared across AOMs by multivariate logistic regression analysis. RESULTS: Among 34,396 adverse events (AEs) related to obesity treatment, 8844 dsAEs were analyzed. Comparing with semaglutide and liraglutide, tirzepatide exhibited fewer reported dsAEs while semaglutide and liraglutide showed a high correlation with non-lethal pancreatitis reports. Bupropion-naltrexone (31.65%) reported the highest number of dsAEs, and a PV signal was detected in mouth and lips AEs (ROR = 2.97, 95% CI: 2.42-3.6). Orlistat (ROR = 3.30, 95% CI: 3.08-3.55) exhibited the highest association with gastrointestinal AEs compared to other AOMs. PV signal for hepatobiliary AEs (ROR = 6.13, 95% CI: 3.45-10.88) with phentermine-topiramate still needs further clarification. CONCLUSIONS: Tirzepatide may be considered for patients with a history of digestive system disease or an elevated risk of pancreatitis based on the pattern of reported dsAEs. Caution is needed for the orofacial AEs when using bupropion-naltrexone. Orlistat has a higher reporting rate of gastrointestinal AEs, but these events are typically less severe. Phentermine-topiramate's association with liver impairment requires further clinical investigation. This article provides insights into the reported associations between AOMs and dsAEs, which may aid clinicians in making more informed decisions about individualizing medication and managing potential adverse events.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Fármacos Antiobesidad , Farmacovigilancia , United States Food and Drug Administration , Humanos , Estados Unidos/epidemiología , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Fármacos Antiobesidad/efectos adversos , Fármacos Antiobesidad/uso terapéutico , Masculino , Femenino , Adulto , Persona de Mediana Edad , Bases de Datos Factuales , Anciano , Adulto Joven , Enfermedades del Sistema Digestivo/inducido químicamente , Enfermedades del Sistema Digestivo/epidemiología , Obesidad/epidemiología , Liraglutida/uso terapéutico , Liraglutida/efectos adversos , AdolescenteRESUMEN
Vasovagal syncope, or fainting, can be triggered by various stimuli, including medical procedures. Syncope after vaccination has been reported, most commonly among adolescents, and can result in injuries. Using the Vaccine Adverse Event Reporting System (VAERS), we reviewed and summarized reports of syncope after live attenuated influenza vaccine, intranasal (LAIV) administered as the sole vaccine (i.e., no concomitant injections). From June 17, 2003 (date of LAIV licensure in the US) through May 31, 2024, VAERS received 50 reports of syncope after LAIV. Nearly half (23; 46 %) pertained to individuals 10-19 years of age. While the vast majority of reports (35; 70 %) did not describe any injuries, 15 people (30 %) were injured, most commonly by falling and hitting their head or face. Twenty-two people (44 %) required evaluation in the emergency department or doctor's office, including an individual who lost consciousness while he was driving home from the vaccination appointment. He did not report any injuries, but the car was severely damaged. Nearly three-quarters of people (37; 74 %) developed syncope within 15 min after vaccination, but fewer than half of reports (24; 48 %) stated that the patient had waited in the observation area for at 15 min. Based on approximately 111.9 million doses of LAIV distributed in the US during the same time period, the reporting rate is approximately 0.4 per million doses, suggesting that syncope following LAIV is rare. The information summarized here may enable clinicians, patients, and caregivers to make a more informed decision regarding preventing injuries that may occur following LAIV-related syncope.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Vacunas contra la Influenza , Síncope , Vacunas Atenuadas , Humanos , Vacunas contra la Influenza/efectos adversos , Vacunas contra la Influenza/administración & dosificación , Adolescente , Vacunas Atenuadas/efectos adversos , Vacunas Atenuadas/administración & dosificación , Adulto Joven , Adulto , Masculino , Femenino , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Niño , Síncope/etiología , Síncope/epidemiología , Persona de Mediana Edad , Gripe Humana/prevención & control , Gripe Humana/complicaciones , Estados Unidos/epidemiología , Anciano , Vacunación/efectos adversos , Administración IntranasalRESUMEN
Background: Analysing data on adverse drug reactions (ADRs) in health facilities is an essential step to help develop effective strategies to reduce their incidence. The objective was to analyse spontaneous ADR reports sent to the Ghanaian Food and Drugs Authority (FDA) by two reporting health facilities over 5 years. Methods: Data from duplicate spontaneous ADR reports sent to the FDA (Ghana) from 2014 to 2018 were extracted. The relationship between independent variables such as age, sex, and source of drugs and ADR outcomes was assessed with either chi-square or a Cramer's V test for association where appropriate. Results: Type A reactions (65.2%) were the most prevalent of the ADRs, followed by Type B (34.1%), with the majority (80%) of patients affected recovering fully. The majority of Type A reactions (54.1%) occurred in the clinic, while the majority of Type B reactions (43.5%) occurred in the hospital. The skin and central nervous system (CNS) were the most affected (70.8%) organs. A higher incidence of CNS and skin-related ADRs was recorded in patients older than 30 (RR = 1.28 (1.07-1.53)). Also, females were more likely to experience a CNS-related ADR. The seriousness of the ADR was found to be significantly associated with the (1) type of prescriber, (2) whether the drug was prescribed, or (3) whether the drug regimen prescribed was appropriate. Even though, in 86% of cases, the offending drug was withdrawn within the first 5 days, it exceeded 20 days in about 6% of cases. The record of allergy status in a patient's folder and the source of the drug were significantly associated with the chance that the offending drug was withdrawn. However, recording ADRs did not influence whether the offending drug was stopped. Conclusion: Most of the ADRs experienced by patients could be avoided if the current systems are improved to prevent the rechallenge of offending drugs. Efforts to improve and update patient medication records and steps to ensure continuity of care are essential in preventing these adverse drug events.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , Femenino , Masculino , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Adulto , Persona de Mediana Edad , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Ghana/epidemiología , Adolescente , Niño , Adulto Joven , Anciano , Preescolar , Lactante , IncidenciaRESUMEN
Background: The P2Y12 receptor inhibitors clopidogrel and prasugrel are widely used. Clopidogrel and prasugrel have different metabolic pathways, but whether their adverse event (AE) profiles differ significantly is unclear. Objective: This study aimed to compare the possible AEs induced by clopidogrel and prasugrel and to assess the rank-order of their AEs submitted to a spontaneous reporting database. Materials and Methods: Data were extracted from the Japanese Adverse Drug Event Report database (JADER). Reports of AEs associated with clopidogrel and prasugrel were analyzed to calculate the reporting odds ratios (RORs) and 95% confidence intervals (CIs). Results: Based on 5869 reports for clopidogrel (69.6%, men) and 513 reports for prasugrel (74.1%, men), 703 and 135 different AEs were identified, respectively. Bleeding complications including hemorrhage were commonly reported for both clopidogrel and prasugrel. As for AEs related to clopidogrel, unexpected AEs such as interstitial lung disease (227 reports; ROR, 1.77; 95% CI, 1.49-2.10), abnormal hepatic function (137 reports; ROR, 1.27; 95% CI, 1.07-1.51), and hepatocellular injury (96 reports; ROR, 120.0; 95% CI, 94.9-151.8) ranked at relatively high positions based on the number of occurrences, unlike prasugrel. Conclusion: This analysis of the national pharmacovigilance database highlights distinct AE profiles for clopidogrel and prasugrel. Unexpected AEs associated with clopidogrel were identified, providing valuable insights for clinical monitoring and patient safety.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Clopidogrel , Enfermedades Pulmonares Intersticiales , Farmacovigilancia , Inhibidores de Agregación Plaquetaria , Clorhidrato de Prasugrel , Antagonistas del Receptor Purinérgico P2Y , Humanos , Clopidogrel/efectos adversos , Clorhidrato de Prasugrel/efectos adversos , Clorhidrato de Prasugrel/uso terapéutico , Japón/epidemiología , Enfermedades Pulmonares Intersticiales/inducido químicamente , Enfermedades Pulmonares Intersticiales/diagnóstico , Enfermedades Pulmonares Intersticiales/epidemiología , Masculino , Inhibidores de Agregación Plaquetaria/efectos adversos , Femenino , Factores de Riesgo , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Persona de Mediana Edad , Anciano , Bases de Datos Factuales , Medición de Riesgo , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Adulto , Pueblos del Este de AsiaRESUMEN
This study analyzed adverse drug events (ADEs) associated with basiliximab, sourced from the Food and Drug Administration Adverse Event Reporting System (FAERS) database, spanning the first quarter of 2004 to the fourth quarter of 2023. We collected ADE data for basiliximab from 2004 Q1 to 2023 Q4. After standardization, we employed several signal quantification methods for analysis, such as the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propensity for Neural Networks (BCPNN), and empirical bayes geometric mean (EBGM). In this analysis of 1520 ADEs reports citing basiliximab as the primary suspect, we identified 295 preferred terms across 24 system organ classifications (SOCs). The 3 most prevalent SOCs were investigated (nâ =â 1403, ROR 2.84, PRR 2.54, IC 1.34, EBGM 2.54), infections and infestations (nâ =â 1198, ROR 2.85, PRR 2.59, IC 1.37, EBGM 2.59), and renal and urinary disorders (nâ =â 903, ROR 6.01, PRR 5.48, IC 2.45, EBGM 5.47). Increased blood creatinine and pyrexia were the most frequently reported adverse events (AEs) associated with basiliximab, and cytomegalovirus infection also demonstrated significant signal intensity. Notably, this study revealed some adverse reactions beyond basiliximab drug instructions, such as mitral valve calcification, diastolic dysfunction, pelvic fluid collection, testicular swelling, soft tissue necrosis, and muscle necrosis. Although basiliximab offers therapeutic benefits, it carries the risk of several adverse reactions. Clinicians should monitor patients for signs of increased serum creatinine level, fever, cytomegalovirus infection, anaphylactic shock, mitral valve calcification, diastolic dysfunction, pelvic fluid collection, testicular swelling, soft tissue necrosis, muscle necrosis, and other events during clinical use.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Basiliximab , Inmunosupresores , United States Food and Drug Administration , Humanos , Basiliximab/efectos adversos , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Estudios Retrospectivos , Estados Unidos , Masculino , Inmunosupresores/efectos adversos , Femenino , Proteínas Recombinantes de Fusión/efectos adversos , Bases de Datos Factuales , Persona de Mediana Edad , AdultoRESUMEN
OBJECTIVE: This study aims to identify safety signals of ophthalmic prostaglandin analogues through data mining the Food and Drug Administration Adverse Event Reporting System (FAERS) database. METHODS: A data mining search by proportional reporting ratio, reporting OR, Bayesian confidence propagation neural network, information component 0.25 and χ2 for safety signals detection was conducted to the FAERS database for the following ophthalmic medications: latanoprost, travoprost, tafluprost and bimatoprost. RESULTS: 12 preferred terms were statistically associated: diabetes mellitus, n=2; hypoacusis, n=2; malignant mediastinal neoplasm, n=1; blood immunoglobulin E increased, n=1; cataract, n=1; blepharospasm, n=1; full blood count abnormal, n=1; skin exfoliation, n=1; chest discomfort, n=1; and dry mouth, n=1. LIMITATION OF THE STUDY: The FAERS database's limitations, such as the undetermined causality of cases, under-reporting and the lack of restriction to only health professionals reporting this type of event, could modify the statistical outcomes. These limitations are particularly relevant in the context of ophthalmic drug analysis, as they can affect the accuracy and reliability of the data, potentially leading to biased or incomplete results. CONCLUSIONS: Our findings have revealed a potential relationship due to the biological plausibility among malignant mediastinal neoplasm, full blood count abnormal, blood immunoglobulin E increased, diabetes mellitus, blepharospasm, cataracts, chest discomfort and dry mouth; therefore, it is relevant to continue investigating the possible drug-event association, whether to refute the safety signal or identify a new risk.