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ABSTRACT Tuberculosis stands as one of humanity's oldest afflictions, intrinsically intertwined with social disparities. This formidable disease spares no age group and remains the prevailing cause of infection-induced mortality worldwide, particularly in developing nations. We present a case of a 56-year-old woman with diabetes who was diagnosed with Pulmonary Tuberculosis. After receiving antituberculosis drugs as part of her treatment, she experienced a range of systemic manifestations and suffered from severe ulcerative esophagitis. This adverse reaction led to uncontrollable gastrointestinal intolerance, tragically resulting in her untimely demise. The incident underscores the potential seriousness of adverse reactions that can arise from tuberculosis treatment medications.

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Background: DRESS syndrome (Drug reaction with eosinophilia and systemic symptoms) is an idiosyncratic reaction characterized by peripheral eosinophilia and systemic symptoms: fever, exanthema, lymphadenopathy, hepatitis, atypical lymphocytes and elevated liver enzymes. The incidence is 1 per 10,000 exposures, mortality 10-20%. Treatment is based on suspension of the suspected drug and steroids. Case report: A 42-year-old male with the following important antecedents. AHF: mother and father with Diabetes Mellitus type 2. APP: Arterial Hypertension, Diabetes Mellitus type 2, and bee sting allergy. Current Condition: He started 8 days after ingestion of hydroxychloroquine for probable SARS-COV-2 infection, with headache, facial and neck edema, desquamative dermatosis on trunk and upper extremities, went to private clinic with torpid evolution sent to third level for increased facial and neck edema, which merited orotracheal intubation, management with intravenous steroids and antihistamines. Labs on admission: Leukocytes 20090, platelets 322 thousand, eosinophilia (5%), elevated liver enzymes and acute kidney injury, fulfilling J-SCAR criteria. The patient was discharged due to adequate evolution with follow-up by Allergy and Clinical Immunology, the patient persists with desquamative lesions after 4 weeks and normalization of laboratory parameters. Conclusions: DRESS is a delayed adverse reaction. It is important the diagnostic presumption and the causal relationship with the drugs due to the high mortality rate.

Antecedentes: El síndrome DRESS (Drug reaction with eosinophilia and systemic symptoms) es una reacción idiosincrática, se caracteriza por eosinofilia perifé- rica y síntomas sistémicos: fiebre, exantema, linfadenopatía, hepatitis, linfocitos atípicos y elevación de enzimas hepáticas. La incidencia es de 1 por cada 10,000 exposiciones, mortalidad de 10 a 20%. El tratamiento se basa en la suspensión del fármaco sospechoso y en la aplicación de esteroides. Reporte de caso: Masculino de 42 años con los siguientes antecedentes de importancia. AHF: madre y padre con Diabetes Mellitus tipo 2. APP: Hipertensión Arterial, Diabetes Mellitus tipo 2, y alergia a picadura de abeja. Padecimiento Actual: Lo inicia posterior a 8 días tras la ingesta de hidroxicloroquina por probable infección por SARS-COV-2, con cefalea, edema facial y de cuello, dermatosis descamativa en tronco y extremidades superiores, acude a clínica particular con evolución tórpida enviado a tercer nivel por aumento de edema facial y cuello, que amerito intubación orotraqueal, manejo con esteroides intravenosos y anti- histamínicos. Laboratorios a su ingreso: Leucocitos 20090, plaquetas 322 mil, eosinofilia (5%), elevación de enzimas hepáticas y lesión renal aguda, cumpliendo criterios J-SCAR. Se egresa por adecuada evolución con seguimiento por Alergia e Inmunología Clínica, el paciente persiste con lesiones descamativas posterior a 4 semanas y normalización de parámetros de laboratorios. Conclusión: DRESS es una reacción adversa retardada. Es importante la presunción diagnóstica y la relación causal con los fármacos por la alta tasa de morta- lidad.

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OBJECTIVES: Veterinarians and pharmacists are familiar with the efficacy and safety aspects attributed to active pharmaceutical ingredients included in medicines, but they are rarely concerned with the safety of excipients present in medicines. Although generally recognized as safe, excipients are not chemically inert and may produce adverse events in certain animal populations. This review aims to present excipients of concern to these populations and highlight their relevance for rational veterinary pharmacotherapy. EVIDENCE ACQUISITION: A comprehensive review of the literature about the existence of adverse reactions in animals caused by pharmaceutical excipients was carried out based on an exploratory study. An overview of the correct conditions of use and safety of these excipients has also been provided, with information about their function, the proportion in which they are included in the different pharmaceutical dosage forms and the usual routes of administration. RESULTS: We identified 18 excipients considered of concern due to their potential to cause harm to the health of specific animal populations: bentonite, benzalkonium chloride, benzoic acid, benzyl alcohol, ethanol, lactose, mannitol, mineral oil, monosodium glutamate, polyethylene glycol, polysorbate, propylene glycol, sodium benzoate, sodium carboxymethylcellulose, sodium lauryl sulfate, sulfites, polyoxyethylene castor oil derivatives, and xylitol. Among the 135 manuscripts listed, only 24 referred to studies in which the substances were correctly evaluated as excipients. CONCLUSIONS: Based on the information presented in this review, the authors hope to draw the attention of professionals involved in veterinary pharmacotherapy to the existence of excipients of concern in medicines. This information contributes to rational veterinary pharmacotherapy and supports veterinary pharmacovigilance actions. We hope to shed light on the subject and encourage studies and new manuscripts that address the safety of pharmaceutical excipients to the animal population.

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BACKGROUND: Quinine is an alkaloid with antipyretic and anti-infective properties, and also an ingredient in tonic waters. Adverse reactions have been reported with this product, such as photosensitivity, vasculitis, and contact dermatitis. CASE REPORT: A 31-year-old male patient who, after 3-4 hours of consuming "Schweppes®" gin with tonic water, manifested ulcers on the lips and oral cavity, and a fixed erythematous lesion on the second phalanx of the hand, 24 hours later. Skin tests with aeroallergens and food were negative, and 48-hour patch tests were positive (quinine [++] and "Schweppes®" [++]). Based on the test findings, the diagnosis of an adverse reaction to quinine, contained in the tonic water, will be established. CONCLUSIONS: Quinine can be found in other types of foods or medications, so it is important to establish an accurate diagnosis and offer adequate recommendations to the patient with the consumption of this product.

ANTECEDENTES: La quinina es un alcaloide con propiedades antipiréticas, antiinfecciosas y, además, un ingrediente del agua tónica. Se han descrito reacciones adversas con este producto, como fotosensibilidad, vasculitis y dermatitis de contacto. REPORTE DE CASO: Paciente masculino de 31 años, que luego de 3-4 horas de consumir ginebra con agua tónica "Schweppes®" manifestó úlceras en los labios y la cavidad bucal, y una lesión eritematosa fija en la segunda falange de la mano, 24 horas después. Las pruebas cutáneas con aeroalérgenos y alimentos resultaron negativas, y las pruebas epicutáneas de 48 horas positivas (quinina [++] y "Schweppes®" [++]). Con base en los hallazgos de las pruebas, se estableció el diagnóstico de reacción adversa por quinina, contenida en el agua tónica. CONCLUSIÓN: La quinina puede encontrarse en diferentes alimentos o medicamentos, por lo que es importante establecer el diagnóstico preciso y ofrecer recomendaciones adecuadas por el consumo de este producto.

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La pancreatitis en pediatría se consideraba anteriormente una enfermedad poco fre­cuente; en la actualidad se reportan 13.2 casos por 100 000 niños/año. La causa más importante de pancreatitis en la población pediátrica, después de la etiología biliar, son los medicamentos (13% de los casos). Uno de los principales medicamentos como causa de pancreatitis en pediatría es el ácido valproico (AV); el cual puede inducir una pancreatitis aguda. Aquí se presentará el primer caso de pancreatitis por AV en población pediátrica reportado en Colombia. Se trata de un paciente de cuatro años, con trastorno en el neurodesarrollo por un síndrome de TORCH, quien tomaba AV a largo plazo por un trastorno de la conducta. Ingresó a una institución de alta complejidad donde se diagnostica pancreatitis aguda con signos de necrosis en tejido pancreático secundario a uso de AV. Se suspendió el medicamento con resolución de su cuadro clínico y alta médica hacia el día 15

Pediatric pancreatitis was previously considered a rare disease. Currently, 13.2 cases are reported per 100,000 children/year. The most important cause of pancreatitis in the pediatric population, after biliary etiology, are medications (13% of cases). One of the main medications as a cause of pediatric pancreatitis is valproic acid (VA), which can lead to acute pancreatitis. Here we will present the first case of VA pancreatitis in the pediatric population reported in Colombia. This is a four-year-old patient, with a neurodevelopmental disorder due to TORCH syndrome, who was taking VA long-term for a conduct disorder. He was admitted to a highly complex institution where acute pancreatitis was diagnosed with signs of necrosis in pancreatic tissue secondary to the use of VA. The medication was discontinued with resolution of his set of symptoms and medical discharge around day 15.

A pancreatite pediátrica era anteriormente considerada uma doença rara; atualmente, 13,2 casos por 100 000 crianças/ano são relatados. A causa mais importante de pancreatite na população pediátrica, depois da etiologia biliar, são os medicamentos (13% dos casos). Uma das principais medicações como causa de pancrea-tite em pediatria é o ácido valpróico (VA); que podem induzir pancreatite aguda. Aqui apresentaremos o primeiro caso de pancreatite AV na população pediátrica relatado na Colômbia. Trata-se de uma paciente de quatro anos de idade, com transtorno do neuro-desenvolvimento devido à síndrome TORCH, que fazia uso de AV de longa duração para um transtorno de conduta. Ele foi internado em uma instituição de alta complexidade onde foi diagnosticado pancreatite aguda com sinais de necrose no tecido pancreático secundário ao uso de AV. A medicação foi suspensa com resolução do quadro clínico e alta médica por volta do 15º dia

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INTRODUCTION: Post-marketing data on coronavirus vaccines are limited. This study evaluated adverse reactions reported to a statewide hotline after the administration of a coronavirus disease-2019 (COVID-19) vaccine. METHODS: We collected reports between 1 December 2020 through 30 August 2021 of any individual 12 years of age and older who received an FDA EUA-approved vaccine and experienced an adverse reaction. For each case, we collected vaccine brand, demographics, adverse reaction type, severity, onset of reaction, duration, and outcome. Relative risk analyses were conducted to investigate factors associated with vaccine adverse reactions. RESULTS: 638 adverse drug reaction cases were recorded. The majority identified as female (70.8%) and the median age was 56. Implicated brands were Pfizer BNT162b2 (46.6%), Moderna mRNA-1273 (43.41%), and Janssen Ad26.COV2.S (8.78%). Although the lowest number of cases was with Janssen, this vaccine had the highest incident rate based on reactions per 100,000 doses. Adverse reactions with the highest incidence were systemic reactions (92.7%), injection-site reactions (8.5%), and local non-injection-site reactions (10.4%), with most judged as minor severity. Relative risk was higher for Moderna compared to Pfizer for injection-site non-severe (RR 2.01) and injection-site severe (RR 1.94) reactions. Janssen had a higher risk of headache, dyspnea, and vision changes compared to Pfizer, and a higher risk of headache compared to Moderna. The relative risk for fever, chills, and lymphadenopathy was higher for the second dose than the first dose for all patients. CONCLUSION: This observational study analyzing adverse drug reactions of the COVID-19 vaccine found that most complaints concerned systemic reactions. We found reaction differences among vaccine brands, between first and second doses for some effects, and selected recurrent events. Poison control centers are uniquely positioned to conduct post-marketing surveillance for the new vaccines as they are available 24/7 to the public and are healthcare providers. Further post-marketing studies are essential to provide a holistic safety profile of COVID-19 vaccines.

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Monoclonal antibodies, such as trastuzumab and rituximab, significantly contribute to the oncological therapeutic arsenal. However, they may be associated with the development of cardiotoxicity. This study collected data from clinical records of patients in the use of rituximab and trastuzumab in a private oncology clinic from 2017 to 2019. It also investigated cardiovascular adverse drug reactions and associated risk factors. Cardiotoxicity was defined as symptomatic in the presence of signs and symptoms suggestive of heart failure (HF) such as dyspnea, nocturnal cough, and fatigue, among others. Asymptomatic HF was confirmed by the decline in the left ventricular ejection fraction (LVEF) ≥10% of baseline or LVEF ≤50%. Among the 57 patients undergoing trastuzumab, 12 patients (21%) had cardiotoxicity and 8 patients (67%) had extreme or high-risk scores in the cardiotoxicity risk assessment algorithm. Among the 37 patients treated with rituximab, 3 patients (8%) had cardiotoxicity. The presence of previous diabetes mellitus significantly increased the risk of trastuzumab-induced cardiotoxicity (p = 0.02). However, none of the other risk factors influenced the incidence of trastuzumab- and rituximab-induced cardiotoxicity, which the sample size may explain. More studies are needed to investigate the association of risk factors with cardiotoxicity induced by trastuzumab and rituximab, aiming to establish strategies to prevent and manage this effect early.

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Drug eruption, also known as cutaneous adverse drug reaction, is a rare disease that is difficult to diagnose, requiring a combination of history evaluation, physical assessment, and histopathological examination. Clinically, it presents with variable signs, from mild urticaria to epidermal necrosis. Treatment consists of discontinuing the causative or similar medication; lesion management; and, sometimes, implementing systemic immunosuppressive treatments. The prognosis is generally good, except when there is systemic involvement or extensive skin necrosis. This study aims to describe the lesions, diagnosis, and evolution of a young cat presenting with drug eruption following the use of multiple medications for the treatment of systemic conditions. The patient underwent skin biopsy after showing progression of alopecic and localized lesions, which resulted in a suggestive diagnosis of superficial pustular drug eruption. Previous drug treatments were interrupted, but due to the lack of improvement in the lesion pattern, we chose to re-administer chlorambucil at a dose of 2 mg/cat every 48 h for therapeutic purposes. Up to the present time, the patient has been undergoing treatment and lesion management, with healthy-looking scar tissue and almost complete resolution of the skin lesions

A farmacodermia ou reação medicamentosa adversa cutânea é uma doença rara e de difícil diagnóstico, que demanda associação de histórico, avaliação física e exame histopatológico. Clinicamente apresenta sinais variáveis, desde leve urticária até necrose epidérmica. O tratamento consiste em descontinuar o medicamento causador ou semelhantes, realizar manejo das feridas e, por vezes, instituir tratamentos sistêmicos imunossupressores. O prognóstico geralmente é bom, exceto quando houver envolvimento sistêmico ou extensa lesão cutânea necrótica. O objetivo deste trabalho é descrever as lesões, diagnóstico e evolução de um gato jovem apresentando farmacodermia após o uso de múltiplas medicações para tratamento de afecções sistêmicas. O paciente foi submetido a biópsia cutânea após apresentar progressão de lesões alopécicas e localizadas, que resultou no diagnóstico sugestivo de farmacodermia pustular superficial. Foram interrompidos os tratamentos medicamentosos prévios, porém não havendo melhora do padrão lesional, optou-se pela readministração de clorambucil na dose de 2 mg/gato a cada 48 horas com objetivo terapêutico. Até o presente momento, o paciente encontra-se sob tratamento e manejo de feridas, com tecido cicatricial de aspecto saudável e quase total resolução de lesões cutânea

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Resumen Algunos estudios sugieren que existe una relación entre el uso de antipsicóticos y el riesgo de tromboembolismo venoso (TEV) y embolia pulmonar (EP). Sin embargo, los resultados siguen sin ser concluyentes. Se trata del caso de un Masculino de 23 años con antecedentes de Esquizofrenia y Depresión tratado quetiapina 800 mg, el cual es encontrado muerto en la cama de un hotel. En la necropsia sin lesiones traumáticas visibles, hallazgos histológicos de tromboembolismo pulmonar masivo con infartos pulmonares secundarios. Laboratorio de Toxicología detectó la presencia de quetiapina, no se detectó alcohol o drogas de abusos. Mediante el Algoritmo De Karch & Lasagna Modificado el tromboembolismo pulmonar fue una reacción adversa con una probabilidad de relación causal posible. Se han informado muchos casos de muerte súbita causada por EP con la exposición a antipsicóticos, pero la relación de su uso y el riesgo de TEV y EP sigue siendo controvertida.

Abstract Some studies suggest a relationship between antipsychotic use and the risk of venous thromboembolism (VTE) and pulmonary embolism (PE). However, the results remain inconclusive. This is the case of a 23-year-old male with a history of schizophrenia and depression treated with quetiapine 800 mg, who was found dead in a hotel bed. At necropsy with no visible traumatic lesions, histological findings of massive pulmonary thromboembolism with secondary pulmonary infarcts. Toxicology laboratory detected the presence of quetiapine, no alcohol or drugs of abuse were detected. Using the Modified Karch & Lasagna Algorithm, pulmonary thromboembolism was an adverse reaction with a probable causal relationship. Many cases of sudden death caused by PE have been reported with exposure to antipsychotics, but the relationship of their use and the risk of VTE and PE remains controversial.

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RESUMEN Introducción: La relación entre eventos adversos y aplicación de medicamentos biológicos en pacientes con diagnóstico de artritis reumatoide ha sido documentada a escala mundial, pero con escasa evidencia en Colombia. Si se asume que los eventos adversos o reacciones medicamentosas con hallazgos clínicos relevantes en la salud, como consecuencia de este tratamiento terapéutico, recaen sobre la calidad de vida del paciente e influyen en los indicadores de salud a escala nacional y en los recursos del sistema, se hace importante evaluar su impacto. Objetivos: Determinar la frecuencia de eventos adversos o reacciones adversas relacionados con el uso de medicamentos biológicos en una cohorte de pacientes con diagnóstico de artritis reumatoide de una aseguradora nacional, en el periodo comprendido entre los arios 2000 y 2019. Metodología: Se realizó un estudio descriptivo, transversal y retrospectivo, con alcance analítico, en pacientes diagnosticados de artritis reumatoide, con terapia biológica, en una aseguradora a escala nacional, con registros en historias clínicas del año 2000 al 2019. Resultados: Se analizaron 252 registros clínicos de usuarios con diagnóstico de artritis reumatoide y terapia biológica. El 62,7% presentó al menos una reacción adversa y se evaluaron 9 fármacos: tocilizumab, etanercept, adalimumab, abatacept, certolizumab, golimumab, infliximab, rituximab y tofacitinib. Este último es un fármaco incluido en este estudio por solicitud de la aseguradora fuente de la información. Conclusiones: En la terapia biológica de pacientes con artritis reumatoide las reacciones adversas son frecuentes, y en un 27,3% resultan severas, lo cual describe una situación previamente desconocida en Colombia.

ABSTRACT Introduction: The relationship between adverse events and the application of biological drugs in patients with a diagnosis of rheumatoid arthritis has been documented worldwide, but with little evidence of the situation in Colombia. If adverse events and / or drug reactions with relevant clinical findings in health because of this therapeutic treatment affect the patient's quality of life and influence health indicators at the national level and system resources, it is important to assess their impact. Objectives: To determine the frequency of adverse events and / or adverse reactions related to the use of biological drugs in a cohort of patients diagnosed with rheumatoid arthritis from a national insurer, in the period from 2000 to 2019. Methodology: A descriptive, cross-sectional, and retrospective study with analytical scope was carried out in patients diagnosed with rheumatoid arthritis, on biological therapy, under a nationwide insurer, with records in their medical records from 2000 to 2019. Results: 252 clinical records of users with a rheumatoid arthritis diagnosis and biological therapy were analysed; 62.7% had at least one adverse reaction; nine drugs were evaluated in this study: Tocilizumab, Etanercept, Adalimumab, Abatacept, Certolizumab, Golimumab, Infliximab, Rituximab, and Tofacitinib. Tofacitinib was included in this study at the request of the insurer providing the information. Conclusions: Adverse reactions with biological therapy in patients with rheumatoid arthritis are frequent and were severe in 27.3%. This is a situation previously unknown in Colombia.

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Snakebite envenomings are considered a global health problem. The specific therapy for these envenomings consists of administering animal-derived antivenoms aiming to neutralize the venom toxins. Antivenoms have been used effectively to treat snakebites for more than a century; however, their administration may result in early and/or late adverse reactions. The present study presents the prevalence of early adverse reactions (EARs) towards Bothrops antivenom therapy in a health tertiary unit in the Brazilian Amazon and explores if specific plasma cytokines and chemokines from envenomed patients could be used as predictors of EARs. A cohort of patients bitten by Bothrops atrox was followed-up at the Fundação de Medicina Tropical Dr. Heitor Vieira Dourado (FMT-HVD), from 2014 to 2016. Patients were treated with the Brazilian Bothrops antivenom and CXCL-8, CCL-5, CXCL-9, CCL-2, CXCL-10, IL-6, TNF, IL-2, IL-10, IFN-y, IL-4, and IL-17A were evaluated in patients' plasma samples before and after antivenom administration. From the total of patients (n = 186), mostly were male (82.3%), inhabiting rural areas (87.1%), with an average age of 35 years. Most of the patients (83.8%) were admitted to the hospital within 6 h after the accident, 26 (14%) reported having suffered a previous snakebite, and 97 (52.1%) received between 7 and 9 antivenom vials. The frequency of antivenom-induced EARs was 11.8% (22), resulting mostly of mild reactions. Urticaria was the major EAR manifestation (46.4%). Interestingly, CXCL-8 and IL-2 showed significantly lower levels in patients who progressed to EARs, although IL-2 levels might not represent biological relevance due the small magnitude difference between groups. This study reveals that CXCL-8 and IL-2 could play a role in the onset of EARs in pit viper envenomings.

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INTRODUCTION: Allergic hypersensitivity reactions related to enzyme asparaginase may occur during intravenous infusion of drugs and other adverse reactions (non-allergic hypersensitivity and hyperammonemia), which do not require discontinuation of therapy as the first case. It makes differential diagnoses between infusion reactions essential to assure the team regarding the right decision to make after the adverse event. This study evaluated a pharmacovigilance strategy of differentiating infusion reactions to asparaginase in pediatric patients, based on the measurement of serum ammonia and the classification of the reactions by clinical symptoms and severity. METHODOLOGY: We included children, diagnosed with ALL, and treated with native Escherichia coli asparaginase in a university hospital. The professional team monitored and evaluated all asparaginase infusions for continuity of treatment (rechallenge), seeing the measurement of serum ammonia and classification of reactions for type and severity grade. Data from this monitoring was collected retrospectively. Chi-square and Mann-Whitney tests were used to compare the ratios between serum ammonia concentration posterior and before asparaginase infusion. RESULTS: 245 infusions in 32 patients were monitored, and 19 reactions were observed in 17 children (53%). Three children have hyperammonemia and continue their treatment. The variation of the serum ammonia levels before and after the infusion was statistically significant, comparing the groups with no reaction or hyperammonemia versus the group with the hypersensitivity reaction. CONCLUSION: The pharmacovigilance strategy applied in the hospital investigated was a useful and inexpensive tool that supported clinical decision-making and enabled the maintenance of asparaginase therapy for three (9,4%) patients followed up.

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Snakebite envenomings are considered a global health problem. The specific therapy for these envenomings consists of administering animal-derived antivenoms aiming to neutralize the venom toxins. Antivenoms have been used effectively to treat snakebites for more than a century; however, their administration may result in early and/or late adverse reactions. The present study presents the prevalence of early adverse reactions (EARs) towards Bothrops antivenom therapy in a health tertiary unit in the Brazilian Amazon and explores if specific plasma cytokines and chemokines from envenomed patients could be used as predictors of EARs. A cohort of patients bitten by Bothrops atrox was followed-up at the Fundação de Medicina Tropical Dr. Heitor Vieira Dourado (FMT-HVD), from 2014 to 2016. Patients were treated with the Brazilian Bothrops antivenom and CXCL-8, CCL-5, CXCL-9, CCL-2, CXCL-10, IL-6, TNF, IL-2, IL-10, IFN-y, IL-4, and IL-17A were evaluated in patients’ plasma samples before and after antivenom administration. From the total of patients (n = 186), mostly were male (82.3%), inhabiting rural areas (87.1%), with an average age of 35 years. Most of the patients (83.8%) were admitted to the hospital within 6 h after the accident, 26 (14%) reported having suffered a previous snakebite, and 97 (52.1%) received between 7 and 9 antivenom vials. The frequency of antivenom-induced EARs was 11.8% (22), resulting mostly of mild reactions. Urticaria was the major EAR manifestation (46.4%). Interestingly, CXCL-8 and IL-2 showed significantly lower levels in patients who progressed to EARs, although IL-2 levels might not represent biological relevance due the small magnitude difference between groups. This study reveals that CXCL-8 and IL-2 could play a role in the onset of EARs in pit viper envenomings.

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Obinutuzumab is a fully humanized monoclonal antibody against CD20 used in the treatment of chronic lymphocytic leukemia. Fatal cardiovascular events have been described, but only in patients with known cardiovascular records. We report the case of an adult male with a high-risk chronic lymphocytic leukemia who developed subendocardial injury, with no evidence of coronary atherosclerosis, during the first administration of obinutuzumab.

El obinutuzumab es un anticuerpo monoclonal completamente humanizado contra CD20, empleado en el tratamiento de leucemia linfocítica crónica. Los eventos cardiovasculares fatales han sido descritos, pero solo en pacientes con antecedentes cardiovasculares conocidos. Presentamos el caso de un hombre adulto con diagnóstico de leucemia linfocítica crónica de alto riesgo que desarrolló injuria subendocárdica, sin evidencia de aterosclerosis coronaria, durante la primera infusión de obinutuzumab.

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Resumen El obinutuzumab es un anticuerpo monoclonal completamente humanizado contra CD20, empleado en el tratamiento de leucemia linfocítica crónica. Los eventos cardiovasculares fatales han sido des critos, pero solo en pacientes con antecedentes cardiovasculares conocidos. Presentamos el caso de un hombre adulto con diagnóstico de leucemia linfocítica crónica de alto riesgo que desarrolló injuria subendocárdica, sin evidencia de aterosclerosis coronaria, durante la primera infusión de obinutuzumab.

Abstract Obinutuzumab is a fully humanized monoclonal antibody against CD20 used in the treat ment of chronic lymphocytic leukemia. Fatal cardiovascular events have been described, but only in patients with known cardiovascular records. We report the case of an adult male with a high-risk chronic lymphocytic leukemia who developed subendocardial injury, with no evidence of coronary atherosclerosis, during the first administration of obinutuzumab.

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OBJECTIVE: To describe the clinical characteristics of cutaneous adverse reactions and cross-sensitivity induced by antiseizure medications and compare the pattern of use of antiseizure medications in patients with epilepsy according to skin rash history. METHODS: We analysed patients with a history of skin rash presenting for up to 12 weeks after initiating antiseizure medication. The history of skin rash was verified by medical charts, interviews, and identification of skin lesions by patients based on illustrative images. The minimum follow-up period was eight months. The control group comprised epilepsy patients with regular antiseizure medication use for at least 12 weeks without skin rash. We included 109 cases and 99 controls. RESULTS: The median (interquartile range) period from the index rash was six years (2-11). Carbamazepine was the trigger medication in 48% of cases and induced skin rashes in all patients with cross-sensitivity and carbamazepine exposure. Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reactions with eosinophilia and systemic symptoms affected 36% of cases. Carbamazepine- or oxcarbazepine-induced maculopapular exanthema occurred earlier (median: one week) than that induced by other antiseizure medications (median: three weeks) (p=0.006). Cross-sensitivity was more common in patients with at least one episode of Stevens-Johnson syndrome (29%) and Stevens-Johnson/toxic epidermal necrolysis overlap (50%) than in patients with maculopapular exanthema (8%) (p=0.01). Although most cases were mild, the pattern of antiseizure medication use differed from that of controls, with a lower proportion of antiseizure medication typically associated with severe cutaneous adverse reactions (carbamazepine, phenytoin, phenobarbital, primidone, oxcarbazepine, and lamotrigine) (p<0.001). Most cases exposed to high-risk medication, however, did not develop cross-sensitivity. SIGNIFICANCE: Cutaneous adverse reaction history may influence antiseizure medication use. Cross-sensitivity is more common in severe cases and most patients are affected by mild, self-limited skin rashes. Further research should consider the relevance of mild skin rashes in lifelong epilepsy treatment.

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RESUMEN La condición neurológica definida por la aparición de alteraciones en la percepción, usualmente interpretada como fenómenos extraños de metamorfosis y despersonalización, se reconoce como síndrome de Alicia en el país de las maravillas. Se presenta el caso de una paciente femenina de 9 años de edad, con el diagnóstico de síndrome de Alicia en el país de las maravillas secundario a medicación crónica con montelukast. El diagnóstico del síndrome psiquiátrico se realizó teniendo en consideración los antecedentes patológicos personales y el examen físico. El síndrome de Alicia en el país de las maravillas tiene un carácter benigno, sumamente infrecuente, y aunque su etiología no es del todo conocida, su aparición como reacción adversa a medicamentos es una opción que debe ser siempre considerada por el médico actuante (AU).

ABSTRACT The neurological condition defined by the appearance of alterations in perception usually interpreted as strange phenomena of metamorphosis and depersonalization is recognized as Alice in wonderland syndrome. The case of a 9-year-old female patient is presented, with the diagnosis of Alice in Wonderland syndrome secondary to chronic medication with montelukast. The diagnosis of the psychiatric syndrome was made taking into account personal pathological history and physical examination. Alice in Wonderland syndrome has a benign, extremely rare character and although its etiology is not fully known, its appearance, as an adverse reaction to medications, is an option that should always be considered by the acting physician (AU).

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INTRODUCTION: Subcutaneous allergen-specific immunotherapy (SCIT) is one of the main cornerstones in the treatment of allergic rhinitis in pediatric patients. It has demonstrated symptoms and quality of life improvement, but it is not exempt from adverse reactions (ADVrs). Nevertheless, there are a few reports that have evaluated their safety. Our objective was to evaluate the ADVr to SCIT in pediatric patients. METHODS: We reviewed 786 clinical records with SCIT from 2005 to 2018, comparing the clinical characteristics of patients with ADVrs with SCIT versus a group of a similar number of patients who completed SCIT (control group, CG). The analysis of ADVrs was according to the World Allergy Organization (WAO) 2010 grading system by frequency analysis, survival curve, and log rank. RESULTS: Of 786 patients, 106 (13.4%) presented ADVrs, and the patients with ADVr had sensitivity and immunotherapy with at least 2 allergens versus CG p < 0.001, containing a combination of standardized and nonstandardized allergens (p = 0.003). The ADVrs were in the buildup phase (p < 0.001). The survival curve showed that 50% had some reaction at 12 weeks of SCIT. The most frequent ADVr was grade 1 in 73/106 patients (68.8%) and grade 2 in 33/106 (31.1%). The log-rank analysis between the grades of the WAO grading system showed a statistically significant difference (p = 0.02). CONCLUSIONS: The SCIT is safe in pediatric patients. The ADVrs are infrequent, grade 1 being the most reported; however, at >12 weeks, the risk of ADVrs that involve 2 organs systems increases.

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In Uruguay, around 60 cases of snakebite accidents occur every year that need to be treated with specific antivenom. They are caused by two snakes of Bothrops genus: Bothrops alternatus and Bothrops pubescens. Snakebite accidents are mandatory notification events, allowing the acquisition of an accurate registry and a fluent communication with the health care services. The aim of this study is to analyze and report the doses administered to achieve the neutralization of the venom and the adverse reactions caused by snake antivenoms used in Uruguay in 2018, when a change was made in the type of antivenom available. In this year, Uruguay started to use the BIOL® antivenom (lyophilized) and this use coexists with traditional antivenom liquid forms (Vital Brazil and Malbran). The number of patients treated with heterologous BIOL® antivenom were 28 and the ones treated with heterologous solutions Malbran and Vital Brazil antivenoms were 21. The initial dose of BIOL antivenom was 8 vials instead of 4 vials regularly used with the others antivenoms and it achieved the neutralization of most cases (27/28 cases). Early adverse reactions were detected in 4 patients (3 in children) treated with BIOL antivenom and there were no adverse reactions in those treated with Malbran or Vital Brazil antivenoms. Lyophilized antivenom BIOL is being used widely in Uruguay without major complications.