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OBJECTIVE: To determine prevalence, causes and risk factors of ADE in hospitalized patients. METHODS: Analytical, observational, case-control study of patients with ADE. For statistical analysis, the following were calculated: percentages, frequencies, averages; odds ratio, χ2 test and multiple binary logistic regression. Data analysis was carried out with the Statistical Package, for the Social Sciences 23 program. RESULTS: A 132 patients were registered: 66 cases (26 EM and 40 RAM) and 66 controls; with average age of 35 years (SD 17.41). The prevalence of adverse drug events was 3.6%. The most frequently reported medications: antibiotics and anti-inflammatories. The frequency of adverse events by gender was: 39.3% men and 60.7% women. The services with the greatest patient care: emergencies, surgery; the most frequent route of administration: intravenous (32.3%). The main symptoms: skin. (32.3%) frequent symptoms: cutaneous. Associated symptoms RAM: type A pruritus (OR: 8.5; p = 0.001; IC95%: 0.035-0.393), type B pruritus (OR: 11; p = 0.001; CI95%: 0.021-0.368) urticaria (OR: 19; p = 0.005; IC95%: 0.007-0.412). Risk factors Associated EAM: female (OR: 2.6; p = 0.05; CI95%: 1.33-5.43), history of allergy (OR: 3.4; p = 0.033; CI95%: 1.04-8.40), prolonged hospital stays (OR: 5.4; p = 0.023; IC95%: 3.82-6.74). CONCLUSIONS: Patient safety is a priority when prescribing any drug, which represents a key point in prevention.
OBJETIVO: Determinar la prevalencia, causas y factores de riesgo asociados con eventos adversos a medicamentos en pacientes hospitalizados. MÉTODOS: Estudio de casos y controles, observacional, analítico, llevado a cabo en pacientes con eventos adversos a medicamentos. Para el análisis estadístico se calcularon: porcentajes, frecuencias, promedios; razón de momios, prueba de χ2 y regresión logística binaria múltiple. El análisis de los datos se efectuó con el programa Statistical Package, for the Social Sciencies 23. RESULTADOS: Se registraron 132 pacientes: 66 casos (26 EM y 40 RAM) y 66 controles, con edad promedio de 35 años (DS 17.41). La prevalencia de eventos adversos a medicamentos fue del 3.6%. Los medicamentos reportados con mayor frecuencia: antibióticos y antiinflamatorios. La frecuencia de eventos adversos por género fue: 39.3% hombres y 60.7% mujeres. Los servicios con mayor atención de pacientes: urgencias y cirugía; vía de administración más frecuente: intravenosa (32.3%). Los principales síntomas fueron los cutáneos. Los síntomas asociados con reacción adversa a medicamentos: prurito tipo A (RM: 8.5; p = 0.001; IC95%: 0.035-0.393), prurito tipo B (RM: 11; p = 0.001; IC95%: 0.021-0.368) urticaria (RM: 19; p = 0.005; IC95%: 0.007-0.412). Los factores de riesgo asociados con eventos adversos a medicamentos: mujer (RM: 2.6; p = 0.05; IC95%: 1.33-5.43), antecedente de alergia (RM: 3.4 p = 0.033; (IC95%: 1.04-8.40) y estancia hospitalaria prolongada (RM: 5.4; p = 0.023; IC95%: 3.82-6.74). CONCLUSIONES: La seguridad de los pacientes es una prioridad al momento de prescribir cualquier fármaco, lo que representa un punto clave en la prevención.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Hospitalização , Humanos , Feminino , Masculino , Fatores de Risco , Adulto , Estudos de Casos e Controles , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Hospitalização/estatística & dados numéricos , Pessoa de Meia-Idade , Adulto Jovem , Prevalência , Adolescente , IdosoRESUMO
INTRODUCTION: Clozapine, a second-generation antipsychotic (SGA), is considered the gold standard medication to treat patients with treatment-resistant schizophrenia (TRS). Despite its efficacy, clozapine is associated with adverse effects, notably neutropenia and agranulocytosis. Other hematological adverse effects are less common. Severe anemia is a rare adverse effect seldom reported in the literature and is typically associated with pure red cell aplasia (PRCA). Nevertheless, the benefits of clozapine in managing TRS make rechallenge a reasonable option. CASE REPORT: We present the case of a 35-year-old man with TRS, resistant to previous antipsychotics, who experienced severe anemia during clozapine treatment. An investigation for clozapine-induced anemia revealed PRCA on myelogram. After discontinuing clozapine, the patient's hemoglobin levels recovered. Subsequent treatments with olanzapine, zuclopenthixol, and aripiprazole proved ineffective, leading us to consider a clozapine rechallenge. The rechallenge, monitored for 58 days, resulted in improved psychiatric symptoms and stable hemoglobin levels. The patient remained stable during 6 months of follow-up, with no hematological changes. DISCUSSION: PRCA is a very rare adverse effect of clozapine. The cause of drug-induced PRCA is still unknown; for clozapine, there are no studies. Rechallenge after a severe and rare adverse effect is a complex decision. This case is the first to report a successful clozapine rechallenge following severe anemia without other blood dyscrasias, emphasizing the imperative need for close monitoring during the rechallenge process. Further study is warranted to understand the predictive factors for a successful outcome in clozapine rechallenges.
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Anemia , Antipsicóticos , Clozapina , Esquizofrenia Resistente ao Tratamento , Humanos , Clozapina/efeitos adversos , Clozapina/administração & dosagem , Masculino , Adulto , Antipsicóticos/efeitos adversos , Antipsicóticos/administração & dosagem , Anemia/induzido quimicamente , Esquizofrenia Resistente ao Tratamento/tratamento farmacológicoRESUMO
OBJECTIVES: Underreporting of adverse drug reactions (ADRs) limits and delays the detection of signs. The aim of this systematic review with meta-analyses was to synthesize the evidence of educational interventions (EIs) efficacy in health professionals to increase ADR reporting, attitudes, and knowledge of pharmacovigilance. EVIDENCE ACQUISITION: A systematic literature review was carried out to identify randomized clinical trials evaluating the efficacy of EI in pharmacovigilance in health professionals to improve ADR reports, knowledge, and attitude toward pharmacovigilance. ADR reports were pooled by calculating Odds Ratio (OR) with a 95% confidence interval (95%CI), while pharmacovigilance knowledge and attitude were pooled by calculating a mean difference (MD) with 95%CI. In addition, the subanalysis was performed by EI type. Meta-analysis was performed with RevMan 5.4 software. PROSPERO registry CRD42021254270. RESULTS: Eight hundred seventy-five articles were identified as potentially relevant, and 11 were included in the systematic review. Metanalysis showed that EI increased ADR reporting in comparison with control group (OR = 4.74, [95%CI, 2.46 to 9.12], I2 = 93%, 5 studies). In subgroup analysis, the workshops (OR = 6.26, [95%CI, 4.03 to 9.73], I2 = 57%, 3 studies) increased ADR reporting more than telephone-based interventions (OR = 2.59, [95%CI, 0.77 to 8.73], I2 = 29%, 2 studies) or combined interventions (OR = 5.14, [95%CI, 0.97 to 27.26], I2 = 93%, 3 studies). No difference was observed in pharmacovigilance knowledge. However, the subanalysis revealed that workshops increase pharmacovigilance knowledge (SMD = 1.85 [95%CI, 1.44 to 2.27], 1 study). Only one study evaluated ADR reporting attitude among participants and showed a positive effect after the intervention. CONCLUSION: EI improves ADR reports and increases pharmacovigilance knowledge. Workshops are the most effective EI to increase ADR reporting.
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Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Conhecimentos, Atitudes e Prática em Saúde , Pessoal de Saúde , Farmacovigilância , Humanos , Pessoal de Saúde/educação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controleRESUMO
Background: Severe cutaneous adverse reactions (SCARs) are associated with morbidity and mortality. Objective: The aim was to determine the different types of SCARs, their morphology, common offending drugs, interventions, and outcomes. Methods: A retrospective cohort study was conducted of all patients admitted to the dermatology service at the University Hospital of the West Indies with Stevens-Johnson syndrome (SJS), SJS/toxic epidermal necrolysis overlap (TEN), TEN, drug reaction with eosinophilia and systemic symptoms and acute generalized exanthematous pustulosis between January 1, 2012 to June 1, 2022. Results: Fifty-one cases (51) met the inclusion criteria for SCAR. SJS, SJS/TEN overlap and TEN together accounted for 71.2% of cases. SCARs were most frequent in the fourth, fifth and 6th decades of life and there was a female preponderance. Antibiotics (31%) and anticonvulsants (29%) were the most common causative agents for SCARs. Most patients had at least 1 complication. The liver was the most common extracutaneous organ affected. Mortality was 7.8%. The main cause of death was sepsis. Limitations: Results were not generalizable. There were missing data and loss to follow-up. Conclusion: Judicious use of antimicrobials and corticosteroids may be beneficial in treatment of severe cutaneous drug reactions.
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AIMS: Neonates hospitalized in neonatal intensive care units (NICUs) commonly experience adverse drug reactions (ADRs). Thus, we aimed to develop and validate a tool for predicting ADRs in neonates hospitalized in NICUs. METHODS: A nested case-control study in an open cohort with neonates admitted to the NICU of a maternity hospital in Natal, Brazil was conducted from January 2019 to January 2022 [Correction added on 4 December 2023, after first online publication: 2023 has been changed to 2019 in the preceding sentence.]. Neonates with ADR were randomly paired with 2 controls. For the development of the tool, a multivariate logistic regression was applied on 2/3 of the sample (cases with respective controls). The model's fit was evaluated using the Hosmer-Lemeshow test for calibration and the Brier score for performance assessment. Validation of the tool was performed by determining the area under the receiver operating characteristic curve with bootstrap adjusted c-statistics. RESULTS: In all, 450 neonates (150 cases and 300 controls) were included in the study. We identified 5 independent risk factors for ADR, 4 related to the neonate (current mechanical ventilation, heart rate ≥178 beats/min, intravenous medications, ≥5 prescription medications) and 1 to the mother (gestational hypertension). The tool had a classification cut-off point of ≥15, and its total score ranged from 0 to 34. In validation, the tool had an area under the receiver operating characteristic curve of 0.74 (95% confidence interval [CI] 0.66-0.81) with sensitivity of 52.02% (95% CI 47.40-56.64) and specificity of 81.35% (95% CI 77.75-84.95). CONCLUSION: The tool demonstrated adequate discriminative ability and utilized 5 commonly monitored variables in the NICU.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Recém-Nascido , Humanos , Feminino , Gravidez , Medição de Risco , Estudos de Casos e Controles , Fatores de Risco , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Cuidados CríticosRESUMO
Introducción: La adherencia al tratamiento farmacológico favorece la supresión viral y reduce la resistencia a la terapia antirretroviral de gran actividad a largo plazo. Objetivo: Determinar la relación entre los aspectos farmacológicos y la adherencia al tratamiento antirretroviral de una IPS colombiana. Metodología: Estudio analítico transversal en pacientes con diagnóstico de VIH en tratamiento antirretroviral entre los años 2012 a 2020. Se utilizó un modelo de regresión logística binaria múltiple con fines explicativos. Resultados: Se analizaron 9835 pacientes donde la proporción de adherencia fue de 90 % y en el modelo ajustado se evaluó su relación con los antecedentes de no adherencia (ORa:0,52 IC95 °/o:0,40-0,66), grupo farmacológico (2 ITIAN + 1 IP u otro) (ORa:1,22 IC95 %:0,99-1,76), dos tomas al día (ORa:1,02 IC95 %:0,74-1,40), unidades al día (≥ 3) (ORa:0,69 IC95 %:0,47-1,02), reacciones adversas a medicamentos (ORa:0,56 IC95 °%:0,40-0,78), polimedicación (ORa:1,36 IC95 %:1,00-1,85), tiempo TAR (1 a 2 años) (ORa:1,63 IC95 %:1,27-2,09),tiempo TAR (6 a 12 meses) (ORa:1,66 IC95 %:1,27-2,18), tiempo TAR (<6 meses) (ORa:1,36 IC95 %:1,03-1,78), tasa de reclamación de los medicamentos (ORa:0,42 IC95 %:0,32-0,55) y antecedentes PRUM (ORa:0,11 IC95 %:0,09-0,14). Discusión: La proporción de adherencia obtenida es superior a lo descrito para otros países (entre 60-77 %); sin embargo se encuentra que los hallazgos correspondientes al efecto de las variables farmacológicas analizadas son acordes a lo descrito en estudios previos en el tema Conclusión: Los antecedentes de no adherencia, reacciones adversas, tasa de reclamación de los medicamentos y antecedentes de problemas relacionados con el uso de medicamentos son aspectos que reducen la probabilidad de adherencia; mientras que el mayor tiempo de uso del tratamiento aumenta la misma.
Introduction: Adherence to drug treatment promotes viral suppression and reduces long-term resistance to highly active antiretroviral therapy (HAART). Objective: To determine the relationship between the pharmacological aspects and adherence to antiretroviral treatment in a Colombian IPS. Methodology: Cross-sectional analytical study in patients with HIV on antiretroviral treatment between 2012 and 2020. A multiple binary logistic regression model was used for explanatory purposes. Results: A total of 9,835 patients were analyzed where the proportion of adherence was 90 % and in the adjusted model its relationship with history of non-adherence was assessed (ORa: 0,52 95 % CI: 0,40-0,66), pharmacological group (2 NRTI + 1 PI or other) (ORa: 1,22 95 % CI: 0,99-1,76), two doses per day (ORa: 1,02 95 % CI: 0,74-1,40), units per day (≥ 3 ) (ORa: 0,69 95 % CI: 0,47-1,02), adverse drug reactions (ORa: 0,56 95 % CI: 0,40-0,78), polypharmacy (ORa: 1,36 95 % CI : 1,00-1,85), ART time (1 to 2 years) (ORa: 1,63 95 % CI: 1,27-2,09), ART time (6 to 12 months) (ORa: 1,66 95 % CI: 1,27-2,18), ART time (<6 months) (ORa: 1,36 95 % CI: 1,03-1,78), inconsistency in the claim (ORa: 0,42 95 % CI: 0,32-0,55) and PRUM history (ORa: 0,11 95 % CI: 0,09-0,14). Discussion: The proportion of adherence obtained is higher than that described for other countries (between 60-77 %); however, the findings corresponding to the effect of the pharmacological variables analysed are in line with those described in previous studies on the subject. Conclusion: The history of non-adherence, adverse reactions, inconsistencies in the claim fill history and problems related to the use of medications are aspects that reduce the probability of adherence. While the longer time of use of the treatment increases adherence.
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OBJECTIVES: To assess the efficacy and adverse events linked to the utilization of fentanyl for perioperative pain management in dentistry. METHODS: This systematic review of randomized clinical trials (RCTs) adhered to the PRISMA guidelines and incorporated various databases. RESULTS: Eleven RCTs studying 674 patients were analyzed. Perioperative pain was predominantly evaluated in patients undergoing surgery for impacted molars, although some studies also included patients with other conditions such as oral submucous fibrosis, maxillary cancer, bony temporomandibular joint ankylosis, irreversible pulpitis, among others. Combined with dexmedetomidine, fentanyl produced enhanced analgesic effects. It demonstrated comparable efficacy when compared to nefopam and nalbuphine. Both intranasal and intravenous administration routes proved equally effective. In four RCTs, the transdermal fentanyl patch outperformed the control group, except in the clinical trial where it was compared to ropivacaine. The main adverse events associated with the use of fentanyl included nausea, vomiting, drowsiness, delirium, and respiratory depression; however, they were like those reported in the comparison groups. CONCLUSIONS: While fentanyl demonstrated satisfactory perioperative analgesic efficacy, there were other alternatives that displayed better or comparable outcomes. Due to the risks and potential for misuse of fentanyl, these alternatives must be considered although adverse events were also reported.
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INTRODUCTION: Adverse drug reactions (ADRs) to antiseizure therapy can worsen the quality of life, reduce adherence, and potentially lead to treatment discontinuation and uncontrolled seizures. OBJECTIVES: The aim of the study was to develop a prognostic model for ADRs to antiseizure therapy in adult patients with epilepsy from Colombia. METHODS: This case-control study included adult patients with epilepsy, who were separated into two groups: one group with ADRs to antiseizure therapy (cases), as determined by a complete evaluation conducted by an epileptologist, and another group without ADRs (controls). Variables were analyzed to identify statistical differences between the two groups and were then selected to construct a prognostic model using logistic regression. The Bonferroni method was applied for multiple comparisons. RESULTS: Three hundred fifty-four patients with epilepsy were studied. One hundred and fifty (42%) patients had ADRs and 204 (57%) patients did not have ADs. A total of 362 ADRs were reported, with a third of them being general symptoms and most frequently occurring with older-generation antiseizure drugs (58%). Female sex, drug-resistant epilepsy, LEV, and CZP were risk factors, whereras the presence of tumoral etiology, absence of seizure triggers, and VPA were identified as protective factors. A prognostic model was constructed using previously reported risk factors for ADRs to antiseizure therapy and other variables available in this population study. In the multivariable analysis, the number of previously used antiseizure drugs (1, 2, or ≥3), TPM, CZP, LEV, PHT, and female sex were predictors of ADRs. The corrected p-values were estimated by the Bonferroni method; however, not all the variables achieved statistical significance with this adjustment. CONCLUSIONS: In adult patients with epilepsy from Colombia, we found that the number of previously used antiseizure drugs, TPM, CZP, LEV, PHT, and female sex were predictive factors for ADRs to antiseizure therapy.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Epilepsia , Humanos , Adulto , Feminino , Anticonvulsivantes/efeitos adversos , Estudos de Casos e Controles , Colômbia/epidemiologia , Qualidade de Vida , Epilepsia/tratamento farmacológico , Epilepsia/induzido quimicamente , Convulsões/tratamento farmacológico , Convulsões/induzido quimicamente , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/tratamento farmacológicoRESUMO
BACKGROUND: Stevens-Johnson syndrome is a severe drug reaction. Sulfonamides have been associated with drug reactions, complications, sequelae, even death. CASE REPORT: A 40-year-old female patient with a medical history of endometriosis and recently diagnosed chronic inflammatory ulcerative colitis. She was treated at the Allergology service of the San Juan de Dios Hospital of the Costa Rican Social Security Fund, and after 20 days of treatment with sulfasalazine she had a severe drug reaction on the skin, compatible with Stevens-Johnson syndrome. The lymphocyte transformation test was positive, confirming sulfasalazine as the causative agent. CONCLUSION: The lymphocyte transformation test is a useful method that can confirm the causative agent and prevent important complications in the future.
ANTECEDENTES: El síndrome de Stevens-Johnson es una reacción medicamentosa severa. Las sulfamidas se han asociado con reacciones medicamentosas, complicaciones, secuelas, incluso la muerte. REPORTE DE CASO: Paciente femenina de 40 años, con antecedentes médicos de endometriosis y colitis ulcerativa crónica inflamatoria de reciente diagnóstico. Fue atendida en el servicio de Alergología del Hospital San Juan de Dios de la Caja Costarricense del Seguro Social, y luego de 20 días de tratamiento con sulfasalazina tuvo una reacción medicamentosa severa en la piel, compatible con síndrome de Stevens-Johnson. La prueba de transformación linfocitaria resultó positiva, con lo que se confirmó la sulfasalazina como el agente causal. CONCLUSIÓN: La prueba de transformación linfocitaria es un método útil que puede confirmar el agente causal y prevenir complicaciones importantes a futuro.
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Colite Ulcerativa , Ativação Linfocitária , Síndrome de Stevens-Johnson , Sulfassalazina , Adulto , Feminino , Humanos , Ativação Linfocitária/efeitos dos fármacos , Síndrome de Stevens-Johnson/diagnóstico , Síndrome de Stevens-Johnson/etiologia , Sulfanilamida/efeitos adversos , Sulfassalazina/efeitos adversos , Sulfonamidas , Colite Ulcerativa/tratamento farmacológicoRESUMO
OBJECTIVE: To determine prevalence, causes and risk factors of ADE in hospitalized patients of a General Hospital. METHODS: Observational and analytical case-control study, carried out in patients hospitalized for adverse drug events, treated at the Hospital General Dr. Eduardo Vázquez N, in Puebla, Mexico, between, June 2019 to June 2021. For the statistical analysis, percentages, frequencies, means, odds ratio, χ2, and multiple binary logistic regression were used. Data were analyzed using the Statistical Package for the Social Sciences 23 program. RESULTS: A total of 132 patients (66 cases and 66 controls) were registered. Of the group of cases, 26 patients treated for medication error and 40 with adverse drug reaction were reported. The prevalence of adverse drug events was 3.6%. The drugs and factors associated with the most reported adverse events were: antibiotics, anti-inflammatories; average age of 35 years (SD: 17.41); gender: 39.3% men, 60.7% women; services re-ported with the greatest attention: Emergencies and Surgery; frequent route of administration: intravenous (32.3%); main symptoms: skin; symptoms associated with adverse drug reactions: type A pruritus [OR: 8.5, p = 0.001(CI95%: 0.035-0.393)], type B pruritus [OR: 11, p = 0.001 (CI95%: 0.021-0.368)]; urticaria [OR: 19, p = 0.005(CI95%: 0.007-0.412)]. Risk factors associated with adverse events were: female gender [OR: 2.6, p = 0.05 (CI95%: 1.33-5.43)], history of allergy [OR: 3.4, p = 0.033 (CI95%: 1.04-8.40)] and prolonged hospital stay [OR: 5.4, p = 0.023 (CI95%: 3.82-6.74)]. CONCLUSIONS: The majority of ADEs were EM or ADR type A, both preventable reactions, so patient safety should be a priority when prescribing.
OBJECTIVO: Determinar la prevalencia, causas y factores de riesgo en pacientes hospitalizados por eventos ad-versos a medicamentos. MÉTODOS: Estudio de casos y controles, observacional y analítico, llevado a cabo en pacientes hospitalizados por eventos adversos a medicamentos, atendidos en el Hospital General Dr. Eduardo Vázquez N, Puebla, México, entre junio de 2019 y junio de 2021. Para el análisis estadístico se utilizaron porcentajes, frecuencias, promedios, razón de momios, χ2 y regresión logística binaria múltiple. Los datos se analizaron con el programa Statistical Package, for the Social Sciencies 23. RESULTADOS: Se registraron 132 pacientes (66 casos y 66 controles). Del grupo de casos se informaron 26 pacientes atendidos por error de medicación y 40 con reacción adversa a medicamentos. La prevalencia de eventos adversos a medicamentos fue del 3.6%. Los medicamentos y factores asociados con eventos adversos más reportados fueron: antibióticos, antiinflamatorios; edad promedio de 35años (DE: 17.41); sexo: 39.3% hombres, 60.7% mujeres; servicios reportados con mayor atención: Urgencias y Cirugía; vía administración frecuente: intravenosa (32.3%); síntomas principales: cutáneos; síntomas asociados con reacciones adversas a medicamentos: tipo A prurito [RM: 8.5, p = 0.001(IC95%: 0.035-0.393)], tipo B prurito [RM:11, p = 0.001 (IC95%: 0.021-0.368)]; urticaria [RM: 19, p = 0.005(IC95%: 0.007-0.412)]. Los factores riesgo asociados con eventos adversos fueron: género femenino [RM: 2.6, p = 0.05 (IC95%: 1.33-5.43)], antecedente de alergia [RM: 3.4, p = 0.033 (IC95%: 1.04-8.40)] y estancia intrahospitalaria prolongada [RM: 5.4, p = 0.023 (IC95%: 3.82-6.74)]. CONCLUSIONES: La mayor parte de los eventos adversos a medicamentos se originan por errores de medicación o reacciones adversas a fármacos tipo A; sin embargo, ambos pueden prevenirse. La seguridad del paciente debe ser prioridad al momento de prescribir cualquier tipo de medicamento.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Urticária , Masculino , Humanos , Feminino , Adulto , Estudos de Casos e Controles , Prevalência , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Fatores de Risco , Hospitais Gerais , Prurido , HospitalizaçãoRESUMO
We report the case of a woman who started with a lichenoid eruption, unfavorable evolution, for which a drug reaction was suspected. The final diagnosis was paraneoplastic pemphigus. Multidisciplinary care and evaluation by an Allergist is important in patients with severe skin reactions, suspected of drug reactions, due to the difficulty in establishing the diagnosis.
Se reporta el caso de una mujer que inició con erupción liquenoide, con evolución desfavorable, por lo que se sospechó una reacción medicamentosa. El diagnóstico final fue pénfigo paraneoplásico. Es importante la atención multidisciplinaria y la evaluación de un alergólogo en pacientes con reacciones cutáneas graves, por sospecha de reacciones farmacológicas, debido a la dificultad para establecer el diagnóstico.
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Toxidermias , Erupções Liquenoides , Síndromes Paraneoplásicas , Pênfigo , Feminino , Humanos , Toxidermias/diagnóstico , Toxidermias/etiologia , Erupções Liquenoides/diagnóstico , Síndromes Paraneoplásicas/diagnóstico , Pênfigo/diagnóstico , PeleRESUMO
Unlike other adverse drug reactions, visceral organ involvement is a prominent feature of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome and correlates with mortality. The aim of this study was to systematically review cases published in PubMed-indexed, peer-reviewed journals in which patients had renal injury during the episode of DRESS syndrome (DS). We found 71 cases, of which 67 were adults and 56% were males. Female sex was associated with higher mortality. Chronic kidney disease (CKD) was present in 14% of patients who developed acute kidney injury (AKI) during DS. In 21% of cases, the kidneys were the only visceral organ involved, while 54% of patients had both liver and kidney involvement. Eosinophilia was absent in 24% of patients. The most common classes of medication associated with renal injury in DS were antibiotics in 34%, xanthine oxidase inhibitors in 15%, and anticonvulsants in 11%. Among antibiotics, vancomycin was the most common culprit in 68% of patients. AKI was the most common renal manifestation reported in 96% of cases, while isolated proteinuria or hematuria was present in only 4% of cases. In cases with AKI, 88% had isolated increase in creatinine and decrease in glomerular filtration (GFR), 27% had AKI concomitantly with proteinuria, 18% had oliguria, and 13% had concomitant AKI with hematuria. Anuria was the rarest manifestation, occurring in only 4% of patients with DS. Temporary renal replacement therapy was needed in 30% of cases, and all but one patient fully recovered renal function. Mortality of DS in this cohort was 13%, which is higher than previously reported. Medication class, latency period, or pre-existing CKD were not found to be associated with higher mortality. More research, particularly prospective studies, is needed to better recognize the risks associated with renal injury in patients with DS. The development of disease-specific biomarkers would also be useful so DS with renal involvement can be easier distinguished from other eosinophilic diseases that might affect the kidney.
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A 7-month-old male Central American tapir with a history of recurrent respiratory diseases and repeated prolonged administration of amoxicillin with clavulanic acid presented with lethargy, severe hyperalgesia, and interscapular ulcerating vesicular lesions with serosanguineous content, as well as dorsal skin peeling, oral ulcers, and thoracic limb, abdominal, and submandibular pustules with surrounding erythema and alopecia. The histopathological analysis and clinical manifestations were compatible with erythema multiforme, which was treated with daily wound cleaning and silver sulfadiazine cream application, as well as oral prednisolone for 15 days, with five daily tapering doses, achieving clinical improvement and an adequate cure of the disease. Vesicular dermatitis syndrome of tapirs is a disease complex including erythema multiforme, a condition rarely diagnosed, since the analyses required for a definitive diagnosis are almost never performed; therefore, it is important to carry out the necessary tests that allow the differentiation of the dermatopathies included in this complex of vesicular skin diseases.
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Purpose of overview: The constant surge in accessing essential medicines creates a greater need for continuous monitoring of usage. The inability to source active pharmaceutical ingredients during the COVID-19 pandemic resulted in drug shortages that increased online requests for medications. E-commerce and social sites have opened the floodgate for the marketing of falsified, substandard, and unregistered pharmaceuticals, making them easily accessible to consumers with the click of a button. A high prevalence of such products with compromised quality highlights further the need for enhanced post-marketing vigilance of safety and quality within the pharmaceutical industry. This review aims to assess the extent to which pharmacovigilance (PV) systems in selected Caribbean countries conform to the minimum World Health Organization (WHO) requirements, highlight the importance of PV in ensuring the safer use of medicines across the Caribbean region, and identify opportunities and challenges in building comprehensive PV systems. Recent Findings: The review finds that while major advancements in PV and adverse drug reaction (ADR) monitoring have occurred in Europe and other parts of the Americas, little has been done in the Caribbean region. Only a few countries in the region are active members of the WHO's global PV network, and ADR reporting is minimal. The reason for low reporting includes a lack of awareness, commitment, and participation of healthcare professionals, manufacturers, authorized distributors, and the general consumers. Summary: Nearly all established national PV systems do not fully conform to the minimum PV requirements by the WHO. Legislation, regulatory framework, political commitment, adequate funding, strategies, and incentives to encourage reporting of ADRs are needed to build sustainable PV systems in the Caribbean.
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PURPOSE: To investigate the association between the use of antidepressants and the risk of upper gastrointestinal tract bleeding (UGIB). METHODS: A Case-control study was conducted in a Brazilian hospital complex. Cases were defined as patients with a diagnosis of UGIB and controls as patients admitted for reasons unrelated to gastrointestinal bleeding, gastric concerns, or complications associated with low-dose aspirin (LDA) or nonsteroidal anti-inflammatory drugs (NSAIDs) use. Sociodemographic and clinical data, comorbidities, drug therapy in use (long-term use and self-medication), and lifestyle habits were recorded through face-to-face interviews. Two groups were defined: use of antidepressants in general and use of antidepressants according to their affinity for serotonin transporters. The presence of synergism between the concomitant use of antidepressants and LDA or NSAIDs on the risk of UGIB was also explored. FINDINGS: A total of 906 participants were recruited (200 in the case group and 706 in the control group). The use of antidepressants was not associated with the risk of UGIB (odds ratio [OR] = 1.503; 95% CI, 0.78-2.88) or the use of antidepressants with high affinity for serotonin receptors (OR = 1.983; 95% CI, 0.81-4.85). An increased risk of UGIB was observed in concomitant users of antidepressants and LDA (OR = 5.489; 95% CI, 1.60-18.81) or NSAIDs (OR = 18.286; 95% CI, 3.18-105.29). Despite the lack of significance, the use of antidepressants appears to be a positive modifier of UGIB risk in LDA and NSAID users. IMPLICATIONS: These findings indicate an increased risk of UGIB in concomitant users of antidepressants and LDA or NSAIDs, suggesting the need to monitor antidepressant users, especially those most likely to develop UGIB. In addition, further studies with larger sample sizes are needed to confirm these findings.
Assuntos
Aspirina , Trato Gastrointestinal Superior , Humanos , Estudos de Casos e Controles , Fatores de Risco , Anti-Inflamatórios não Esteroides/efeitos adversos , Antidepressivos/efeitos adversos , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologiaRESUMO
Drug reaction with eosinophilia and systemic symptoms, known by its acronym in English as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms), clinically manifests with fever, facial edema, lymphadenopathy, a morbilliform rash, and organ involvement. Laboratory results reveal leukocytosis, atypical lymphocytes, eosinophilia, and alterations of liver and kidney function tests. The actual incidence of DRESS is unknown, because it may vary depending on the type of medication and the immune status of each patient; also, because many cases remain undiagnosed or untreated. The drugs most associated with DRESS include antiepileptics, antibiotics, antituberculosis, and non-steroidal anti-inflammatory agents (NSAIDs). Its diagnosis is sometimes made late and can become a challenge. The diagnostic criteria proposed by the international Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) help to establish the diagnosis through a score system based on clinical and laboratory findings. The first step to identify the culprit is a thorough clinical history that includes all suspects, emphasizing those most known to cause DRESS syndrome according to the context and the literature. A skin biopsy may also be helpful in the diagnostic process. Patch testing is the test of choice to search for the culprit in cases of DRESS. Regarding prognosis, the estimated mortality due to DRESS is 3.8%. The main causes of mortality include fulminant hepatitis and liver necrosis. Several indicators of poor prognosis have been identified and these include an eosinophil count above 6000 × 103/µL, thrombocytopenia, pancytopenia, leukocytosis and coagulopathy. This article aims to review the evidence available regarding the epidemiology, pathophysiology, clinical and laboratory findings, diagnosis, and treatment of DRESS.
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Self-medication is a part of the self-care practices carried out by the elderly in their environment. The aim of this case report is to show how the self-medication of fluoxetine and dimenhydrinate in an older adult can induce serotoninergic and cholinergic syndromes, showing symptoms such as nausea, tachycardia, tremor, loss of appetite, memory loss, decreased vision, falls, and increased urination. An older adult who has been diagnosed with arterial hypertension, dyslipidemia, diabetes mellitus, and a recent diagnosis of essential thrombosis is the subject of this case report. After the analysis of the case, cessation of fluoxetine was recommended to avoid withdrawal symptoms, therefore decreasing the need for dimenhydrinate and the medicines used for dyspepsia. After the recommendation, the patient showed an improvement in the symptoms. Finally, the comprehensive evaluation process of the medication in the Medicines Optimization Unit achieved the detection of the problem and improved the patient's health condition.
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Durante la pandemia por COVID-19 se observaron diversas reacciones adversas a fármacos. Esto pudo haber estado relacionado con una mayor susceptibilidad inmunológica de los pacientes con SARS-CoV-2 a presentar este tipo de cuadros, así como también con la exposición a múltiples medicamentos utilizados en su tratamiento. Comunicamos el caso de un paciente con una infección respiratoria grave por COVID-19, que presentó 2 reacciones adversas graves a fármacos en un período corto de tiempo. (AU)
During the COVID-19 pandemic, various adverse drug reactions were observed. This could have been related to a greater immunological susceptibility of patients with SARS-CoV-2 to present this type of symptoms, as well as exposure to multiple drugs used in their treatment. We report the case of a patient with a severe respiratory infection due to COVID-19, who presented 2 serious adverse drug reactions associated with paracetamol in a short period of time. (AU)