RESUMEN
High-risk drugs, which are potentially a source of serious adverse reactions, are a major concern in healthcare establishments, particularly for geriatric patients, who often have multiple medications and co-morbid conditions. With a view to continuously improving the quality and safety of care, we have embarked on a proactive approach aimed at identifying, securing and improving the management of medicines at risk in geriatric wards.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , Anciano , Francia , Polifarmacia , Hospitales EspecializadosRESUMEN
INTRODUCTION: This case report describes the long-term success of a subcutaneous ureteral bypass device in a dog for treatment of a ureteral obstruction. The suspected xanthine urolithiasis was secondary to treatment with allopurinol for leishmaniasis. The dog presented initially with lethargy, anuria and abdominal pain. Mild azotemia was found on biochemical analysis and abdominal ultrasound revealed bilateral ureteral obstruction. A subcutaneous ureteral bypass was subsequently placed using a standard surgical technique. The dog recovered uneventfully and the azotemia resolved within days. Follow-up examinations were performed every trimester for over three years and no complications like obstruction of the bypass tubes, urinary tract infection or azotemia were recognized during this follow-up period. Allopurinol was replaced with domperidone as long-term treatment against Leishmaniasis which resulted in a mild increase of the leishmania serum antibody titer. The subcutaneous ureteral bypass placement was successful and safe in this dog and is a valuable alternative in cases of ureteral obstruction also in dogs.
INTRODUCTION: Ce rapport de cas décrit le succès à long terme d'une dérivation urétérale sous-cutanée chez un chien pour le traitement d'une obstruction urétérale. L'urolithiase xanthique suspectée était secondaire à un traitement à l'allopurinol contre la leishmaniose. Le chien a d'abord présenté une léthargie, une anurie et des douleurs abdominales. L'analyse biochimique a révélé une légère azotémie et l'échographie abdominale a révélé une obstruction urétérale bilatérale. Une dérivation urétérale sous-cutanée a été mise en place selon une technique chirurgicale standard. Le chien s'est rétabli sans incident et l'azotémie a disparu en quelques jours. Des examens de suivi ont été effectués tous les trimestres pendant plus de trois ans et aucune complication telle qu'une obstruction du tube de dérivation, une infection urinaire ou une azotémie n'a été constatée au cours de cette période de suivi. L'allopurinol a été remplacé par de la dompéridone dans le cadre d'un traitement à long terme contre la leishmaniose, ce qui a entraîné une légère augmentation du titre des anticorps sériques contre la leishmaniose. La mise en place d'une dérivation urétérale sous-cutanée s'est avérée efficace et sûre chez ce chien et constitue une alternative intéressante en cas d'obstruction urétérale, y compris chez les chiens.
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Azotemia , Enfermedades de los Gatos , Enfermedades de los Perros , Leishmaniasis , Obstrucción Ureteral , Urolitiasis , Animales , Perros , Gatos , Obstrucción Ureteral/etiología , Obstrucción Ureteral/cirugía , Obstrucción Ureteral/veterinaria , Alopurinol/uso terapéutico , Azotemia/veterinaria , Urolitiasis/cirugía , Urolitiasis/veterinaria , Leishmaniasis/veterinaria , Xantinas , Stents/veterinaria , Enfermedades de los Perros/tratamiento farmacológico , Enfermedades de los Perros/cirugíaRESUMEN
INTRODUCTION: Bariatric surgery is the only treatment for severe obesity (BMI>35kg/m2) currently recognized as effective both in achieving tangible and lasting weight loss, and in improving obesity-related comorbidities such as type 2 diabetes, hypertension, and cardiovascular complications. Bariatric surgery, like any other surgery of the digestive tract, can have an impact on nutrient absorption, as well as on drug absorption. The literature on drug management in bariatric surgery patients concerned mainly of case reports and retrospective studies involving a small number of patients. No official guidelines are available. METHODS: We conducted a literature search on the consequences of bariatric surgery in terms of drug bioavailability and/or effect. The Medline® (PubMed) database was searched using the following keywords: "bariatric surgery", "bioavailability", "gastric bypass", and "obesity". We completed this review with an analysis of reports of adverse drug reactions (ADRs) in post-bariatric surgery patients for obesity registered in the National pharmacovigilance database (PVDB). We selected all cases with the mention of "bariatric surgery and/or gastrectomy" as "medical history". After reading the cases, we excluded those in which the patient had undergone surgery for an indication other than obesity, where the route of administration was other than oral, and cases in which ADRs resulted from voluntary overdose, attempted suicide, allergy, switch to Levothyrox® new formulation, meningioma under progestative drugs, inefficacy related to generic substitution and medication error. RESULTS: The literature search identified mainly "case report" about the impact of bariatric surgery on so-called "narrow therapeutic window" drugs. We identified 66 informative cases out of a total of 565 cases selected (11%) in the PVDB. Nevertheless, the information does not allow a clear relationship between the occurrence of the ADR and the influence of bariatric surgery. CONCLUSION: There is a lack of official information and/or recommendations on medication use in subjects who have undergone bariatric surgery. Apart from under-reporting, ADRs reports remain largely uninformative. Health professional and patients would be awareness for improving, quantitatively and qualitatively the reporting of ADRs in this population.
RESUMEN
Bullous pemphigoid affects people who are usually very frail, because they are very old and frequently have neurological co-morbidities. Over the past twenty years, therapeutic management has improved thanks to the application of highly potent corticosteroid-based creams, following a well-established regimen, for several months. Well-conducted nursing care is therefore essential not only to cover wounds, but also to treat the disease. Dedicated nursing time is also an opportunity to provide support to patients, who are often very uncomfortable.
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Penfigoide Ampolloso , Humanos , Penfigoide Ampolloso/tratamiento farmacológico , Penfigoide Ampolloso/etiologíaRESUMEN
INTRODUCTION: Immune checkpoint inhibitors (ICI) have revolutionized cancer treatment in recent years, but have led to the emergence of new so-called immune-related adverse events (irAE). The objective of this study was to determine whether cancer type is a potential predictive factor of irAEs. METHODS: This retrospective study included patients who had started an ICI treatment between 2019 and 2020 at the Grenoble Alpes University Hospital. A logistic regression model and a Fine and Gray survival model with death as a competing risk were used to identify variables associated with grade≥2 irAEs and grade≥2 irAEs-free survival. RESULTS: Of the 512 patients included, 160 (31.2%) had a grade≥2 irAE. Grade≥2 irAEs were less frequent in head and neck cancer compared to other cancers. Ipilimumab (odds ratio [OR]: 6.05; 95% confidence interval [CI]: 2.81-13.7), treatment duration (OR: 1.01; 95% CI: 1.01-1.02), and history of autoimmune disease (OR: 6.04; 95% CI: 2.45-16.5) were independently associated with grade≥2 irAEs. With death as a competing risk, grade≥2 irAEs-free survival was independently improved with treatment duration (subdistribution hazard ratio [sdHR]: 0.93; 95% CI: 0.92-0.94), ipilimumab (sdHR: 0.24; 95% CI: 0.1-0.59) and history of autoimmune disease (sdHR: 0.23; 95% CI: 0.08-0.69) whereas it was poorer for patients with performance status≥2 (sdHR: 2.04; 95% CI: 1.5-2.76) and an older age (sdHR: 1.02; 95% CI: 1.00-1.03). CONCLUSION: Ipilimumab and history of autoimmune disease were both associated with the presence of grade≥2 irAEs and grade≥2 irAEs-free survival. The different cancer groups were not.
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Antineoplásicos Inmunológicos , Enfermedades Autoinmunes , Neoplasias , Humanos , Inhibidores de Puntos de Control Inmunológico/efectos adversos , Ipilimumab/efectos adversos , Estudios Retrospectivos , Antineoplásicos Inmunológicos/efectos adversosRESUMEN
The pandemic subsequent to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus resulted, for the French institutional pharmacovigilance, in a "health crisis" in 2 phases: the coronavirus disease 2019 - "COVID-19" phase during which the missions of the Regional Pharmacovigilance Centres (RPVC) were to detect a possible impact of drugs on this disease, as whether existed a possible aggravating role of certain drugs, or the safety profile of drugs used for the management of COVID-19 could evolve. The second phase followed the availability of COVID-19 vaccines, during which the RPVCs' missions were to detect as early as possible any new serious adverse effect, source of a potential signal that would modify the benefit/risk ratio of a vaccine and require the implementation of health safety measures. During these two periods, signal detection remained the core business of the RPVCs. The RPVCs had to organize themselves to handle an historical surge of declarations and requests for advice, whereas the RPVCs in charge of monitoring vaccines had to deal with an extraordinary dense activity over a long period of time, in order to produce in real time and on a weekly basis, a summary of all the declarations and an analysis of safety signals. The national organization put in place made it possible to meet the challenge of real-time pharmacovigilance monitoring of 4 vaccines with conditional marketing authorizations. Short-circuit efficient exchanges with the French Regional Pharmacovigilance Centres Network was paramount for the French National Agency for medicines and health products (Agence nationale de sécurité du médicament et des produits de santé) to develop an optimal collaborative partnership. The RPVC network has shown agility and flexibility, has been able to adapt swiftly and demonstrated its effectiveness in the early detection of safety signals. This crisis confirmed the superiority of manual/human signal detection as the most effective and powerful tool to date, to rapidly detect a new adverse drug reaction and enable to elaborate rapid measures of risk reduction. In order to maintain the performance of French RPVCs in signal detection and to monitor all drugs as they should and as expected by our fellow citizens, a new funding model correcting the inadequacy of RPVCs' expertise resources in relation to the volume of reports should be considered.
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Vacunas contra la COVID-19 , COVID-19 , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Pandemias , Farmacovigilancia , SARS-CoV-2RESUMEN
OBJECTIVES: To date, very few cannabis-based specialities are authorised on the French market despite a growing demand from patients and health professionals. The objective of this study is to review the tolerance profile and the French legislative status of the two main cannabinoids used for therapeutic purposes: tetrahydrocannabiol (THC) associated with psychoactive effects and non-psychoactive cannabidiol (CBD). METHODS: This review is based on relevant articles retrieved by a search in Google Scholar and PubMed databases and on an assessment of the legal texts and summaries of product characteristics available in France. RESULTS: Evidence for the tolerability of CBD during chronic use is reassuring, but a significant risk of drug interactions exists. THC use appears to be associated with a higher proportion of serious adverse effects, including neuropsychological and cardiovascular effects. Inhaled cannabis appears to be associated with greater toxicity than the oral route. These data are presented together with the pharmacokinetic and pharmacodynamic data of THC and CBD. CONCLUSION: The literature reports several frequent but rarely serious adverse effects of CBD during chronic use as well as a significant risk of drug interactions. THC use seems to be associated with a higher proportion of serious adverse effects compared to CBD, particularly at the neuropsychological and cardiovascular levels. Health professionals should be up to date on the particularities of therapeutic cannabis in terms of efficacy, safety and drug interactions.
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Cannabidiol , Cannabinoides , Cannabis , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , Cannabis/efectos adversos , Dronabinol/efectos adversos , Cannabidiol/efectos adversos , Extractos VegetalesRESUMEN
INTRODUCTION: MetforminHydrochloride is an antidiabetic used for many years, currently; it considered the first choice in treatment of type 2 diabetes (T2D). It decreases insulin resistance, does not induce hypoglycaemia, increases glucose utilization in the liver and skeletal muscle, and decreases hepatic glucose production. Its adverse effects (AE) are gastrointestinal, decrease in vitamin B12 absorption, abnormalities of hemogram and rarely skin reactions. The objective of this study was to report the type and frequency of AEs of Metformin Hydrochloride used in the therapeutic management of T2D patients admitted to the medical center and the diabetes home of Sidi Bel-Abbès in Algeria. MATERIALS AND METHODS: A cross-sectional descriptive study was carried out over a period of four months, from January 1st, 2017 to April 30th, 2017, involving 130 patients treated with Metformin Hydrochloride consulting at Mimoun City Diabetes Home and Gambetta Diabetes Center in the town of Sidi Bel-Abbès. The primary outcome measure was the determination of the type and frequency of AEs related to normal dosages or overdose use of Metformin Hydrochloride in T2D. Data were collected from patient records, using a questionnaire, and analyzed using Statistical Package for the Social Sciences, version 20 software. RESULTS: 130 patients were included, including 82 women, with a mean age of 51.08±8.85 years (30-66). One hundred and ninety-eight (198) AEs were reported, an average of 1.52 AEs per patient. Among them, 95 (47.98%) AEs are digestive disorders (30.77% of patients suffered from diarrhea, 10.77% had nausea and vomiting, 8.46% suffered from abdominal pain and bloating, 3.85% lost their taste, 7.69% complained of epigastric cramps and 11.54% of anorexia), 29 (14.65%) AEs are hypoglycaemia, 73 (36.87%) AEs are other symptoms and 1 (0.50%) EI is vitamin B12 deficiency and no cases of lactic acidosis or allergic reaction were reported. Five (3.85%) patients had a total and lasting intolerance to Metformin Hydrochloride leading to its discontinuation following persistent diarrhoea. CONCLUSION: AEs of Metformin Hydrochloride used in the management of T2D patients consulting at the medical center and the Diabetes home of Sidi Bel-Abbès are frequent. Digestive disorders were the most frequent, diarrhea was very frequent and led to discontinuation of treatment in 3.85% of T2D patients, followed by nausea and vomiting, then abdominal pain, bloating and epigastric cramps, and rarely taste metallic. Hypoglycaemia was frequent following its association with insulin, the onset of headaches and fatigue were frequent, but no case of lactic acidosis or allergic reaction was reported. Due to a lack of means, the dosage of homocysteine and methylmalonic acid had not been carried out to confirm the vitamin B12 deficiency in the patient whose level was less than 200ng/mL. A precise assessment of the imputability of reported AEs is necessary.
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Acidosis Láctica , Diabetes Mellitus Tipo 2 , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Hipersensibilidad , Hipoglucemia , Metformina , Monjas , Deficiencia de Vitamina B 12 , Humanos , Femenino , Adulto , Persona de Mediana Edad , Metformina/efectos adversos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Estudios Transversales , Calambre Muscular/inducido químicamente , Calambre Muscular/complicaciones , Calambre Muscular/tratamiento farmacológico , Vitamina B 12/uso terapéutico , Hipoglucemiantes/efectos adversos , Deficiencia de Vitamina B 12/inducido químicamente , Deficiencia de Vitamina B 12/complicaciones , Deficiencia de Vitamina B 12/tratamiento farmacológico , Hipoglucemia/inducido químicamente , Hipoglucemia/complicaciones , Hipoglucemia/tratamiento farmacológico , Hipersensibilidad/complicaciones , Hipersensibilidad/tratamiento farmacológicoRESUMEN
Introduction :Une forte consommation des benzodiazépines (BZDs) a été remarquée en dehors parfois des règles de recommandations de prescription, ce qui rend leur consommation un problème majeur de santé publique. La présente étude a eu pour objectif d'évaluer la prescription et l'usage des BZDs dans la ville de Sidi Bel-Abbès. Méthodes-Il s'agissait d'une étude descriptive transversale réalisée du 01 Février 2018 au 30 Juin 2018 évaluant la prescription et l'usage des BZDs dans la ville de Sidi Bel-Abbès au moyen d'un questionnaire distribué aux patients de l'hôpital psychiatrique, du service de psychiatrie du CHU et aux pharmaciens d'officine.Le critère de jugement principal était l'évaluation de la prescription et de l'utilisation des BZDs dans cette ville. La saisie et l'analyse des données ont été réalisées par le logiciel SPSS. Résultats-Au total, 353 patients traités au moins par une BZD ont été inclus dont 178 hommes. Le taux de prescription des BZDs était de 1.10, des jeunes (59,77 %) et des personnes mariées (60,34%) constituaient les consommateurs privilégiés. La prescription était l'apanage des psychiatres, en monothérapie (07,42%), la molé cule la plus fréquemment prescrite était le Bromazépam (31,07%) et la prise noc turne était la plus importante (49,01%). Les BZDs étaient utilisées pour combattre l'insomnie (25,21%), l'anxiété (16,43%), pour une durée de plus d'une année (57,79 %). Conclusion-La prescription et l'utilisation des BZDs dans la ville de Sidi Bel-Abbès s'est avérée importante. L'insomnie et l'anxiété constituaient les principales raisons de leur utilisation, et le Bromazépam était la molécule la plus fréquemment utilisée .
Introduction-A high consumption of benzodiazepines (BZDs) has been noticed so metimes outside the rules of prescription recommendations, which makes their consumption a major public health problem. The present study aimed to evaluate the prescription and use of BZDs in Sidi Bel-Abbès city. Methods-: This was a descriptive cross-sectional study carried out from February 01st, 2018 to June 30th, 2018 evaluating the prescription and use of BZDs in of Sidi Bel-Abbès by means of a questionnaire distributed to patients from the psychiatric hospital, the CHU psychiatry department and community pharmacists. The primary endpoint was the assessment of the prescription and use of BZDs in this city. Data entry and analysis were performed using SPSS software. Results-A total of 353 patients treated with at least one BZD were included, including 178 men. The prescription rate of BZDs was 1.10, young people (59.77%) and married people (60.34%) were the privileged consumers. The prescription was the prerogative of psychiatrists, in monotherapy (07.42%), the molecule most frequent ly prescribed was Bromazepam (31.07%) and night intake was the most important (49.01%). BZDs were used to combat insomnia (25.21%), anxiety (16.43%), for a period of more than a year (57.79%). Conclusion-The prescription and use of BZDs in Sidi Bel-Abbès has proven to be important. Insomnia and anxiety were the main reasons for their use, and Bromazepam was the most molecule frequently used.
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Humanos , Masculino , Femenino , Adolescente , Adulto , Persona de Mediana Edad , Anciano , Ansiedad , Benzodiazepinas , Bromazepam , Trastornos Relacionados con Sustancias , Usos Terapéuticos , Medicamentos bajo Prescripción , Efectos Adversos a Largo Plazo , Trastornos del Inicio y del Mantenimiento del Sueño , Formas de Dosificación , Argelia , Uso Excesivo de los Servicios de SaludRESUMEN
INTRODUCTION: Chronic myeloid leukemia (CML) is a malignant hemopathy within the framework of chronic myeloproliferative syndromes, predominant on the granular line. Her drug treatment is based on tyrosine kinase inhibitors (TKIs) which inhibit the abnormal BCR-ABL protein kinase that causes CML and thus block the signals that cause cancer cells to multiply abnormally. However, other proteins are also inhibited, so they can cause a wide range of adverse effects (AEs). The objective of this study was to study the prevalence of AEs of TKIs used in the therapeutic management of CML by the hematology department of University Hospital Center (UHC) of Sidi Bel-Abbes in Algeria and that of the ITK discontinuation following an AE. MATERIALS AND METHODS: It was a retrospective descriptive study carried out over a period of four months, from April 01st, 2021 to July 31st, 2021, on CML patients treated with TKI in the hematology department of Sidi Bel-Abbes HUC in Algeria. The primary outcome measure was the prevalence of AEs associated with the use of normal dosages or overdose of the following TKIs: Imatinib, Dasatinib and Nilotinib. Data were collected from patient charts, filled by doctors of hematology department, using questionnaire, and analyzed by Statistical Package for the Social Sciences software, version 20. RESULTS: A total of 40 patients were included, including 22 women, mean age 51.55±11.66years (23-78). Twenty-six patients reported at least one AE. Among the 106 AEs declared, 69 AEs (65.09 %) declared with Imatinib, 26 AEs (24.53 %) with Dasatinib and 11 AEs (10.38 %) with Nilotinib. A predominance of musculoskeletal effects 43 (40.56 %), followed by general disorders 18 (17 %), myelosuppression 14 (13.20 %) and digestive system 12 (11.32 %). AEs were responsible for permanent discontinuation of ITK in three cases (11.54 %), including two cases (07.70 %) on Imatinib because of neutropenia and one case (03.84 %) onDasatinibsuffering from pleural effusion. AEs could be controlled in 13 (50 %) of cases, including 9 (34.62%) by temporary discontinuation and 4 (15.38 %) by reducing the dosage, allowing improvement of symptoms and continuation or reintroduction of treatment. CONCLUSION: The prevalence of AEs was high in the studied population, their occurrence was inevitable, good management of AEs from the start of treatment is necessary to avoid switching to another TKI, especially in good responders. It is recommended to establish a low-sodium diet beforehand for all TKIs and a low-carbohydrate diet, especially for Nilotinib, and not to rush to stop the TKI because most often, EIs regress over time in order to allow good therapeutic adherence and obtain better results.
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Antineoplásicos , Leucemia Mielógena Crónica BCR-ABL Positiva , Adulto , Femenino , Humanos , Persona de Mediana Edad , Antineoplásicos/efectos adversos , Dasatinib/efectos adversos , Hospitales Universitarios , Enfermedad Iatrogénica , Mesilato de Imatinib/efectos adversos , Leucemia Mielógena Crónica BCR-ABL Positiva/tratamiento farmacológico , Leucemia Mielógena Crónica BCR-ABL Positiva/epidemiología , Prevalencia , Inhibidores de Proteínas Quinasas/efectos adversos , Proteínas Quinasas/uso terapéutico , Estudios RetrospectivosRESUMEN
INTRODUCTION: The aim of the vigilance system in Switzerland is the evaluation and classification of reported suspected adverse reactions of immunological veterinary medicines (IVMP), including suspected lack of expected efficacy. The Institute of Virology and Immunology (IVI) is the competent authority for marketing authorizations of immunological veterinary medicinal products in Switzerland and responsible for the vaccinovigilance system. In 2020, 130 adverse reaction reports were received (5% less compared to 2019). The reports mainly concerned dogs (41%) and cats (25%) followed by cattle (18%) and horses (7%). Many of the reports in dogs involved the application of combined vaccines against canine distemper, hepatitis, parvovirosis and parainfluenza in combination with canine leptospira components, in cats against cat flu and feline panleukopenia in combination with feline leukaemia virus infection. Causality assessments were done according to the international ABON system. In 27% of the reported cases, the causality assessments between the vaccination and the reaction described were evaluated as being probable (ABON A), in 44% as possible (ABON B).
INTRODUCTION: L'objectif du système de vaccinovigilance en Suisse est l'évaluation et la classification des effets indésirables suspectés signalés en rapport à des médicaments vétérinaires immunologiques, y compris le manque présumé d'efficacité attendue. L'Institut de virologie et d'immunologie (IVI) est l'autorité compétente pour les autorisations de mise sur le marché des médicaments immunologiques vétérinaires en Suisse et est responsable du système de vaccinovigilance. En 2020, 130 déclarations d'effets indésirables ont été reçues (5% de moins par rapport à 2019). Les signalements concernaient principalement les chiens (41%) et les chats (25%) suivis des bovins (18%) et des chevaux (7%). Chez les chiens, ces annonces impliquaient principalement l'application de vaccins combinés contre la maladie de Carré, l'hépatite, la parvovirose et la parainfluenza en combinaison avec la leptospirose, chez les chats contre le coryza et la panleucopénie féline en association avec la leucose féline. Les évaluations de causalité ont été effectuées selon le système international ABON. Dans 27% des cas rapportés, les évaluations de causalité entre la vaccination et la réaction décrite ont été évaluées comme probables (ABON A), dans 44% comme possibles (ABON B).
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Vacunas , Drogas Veterinarias , Vacunas Virales , Animales , Bovinos , Perros , Caballos , Suiza , Vacunación/efectos adversos , Vacunación/veterinaria , Vacunas/efectos adversos , Vacunas Combinadas , Drogas Veterinarias/efectos adversos , Vacunas Virales/efectos adversosRESUMEN
OBJECTIVES: The primary objective of the present study was to describe the characteristics of adverse drug reactions (ADRs) linked to self-medication that were notified to the French Pharmacovigilance Database (FPVD) during the COVID-19 outbreak in 2020 first wave. The secondary objective was to compare the characteristics of these ADRs in 2020 with those notified during the same calendar period a year previously. MATERIAL AND METHODS: We analyzed ADRs recorded in the FPVD between March 15th and May 31st, 2020 vs. the same dates in 2019. Only ADRs linked to self-medication were analyzed. Descriptive statistics were used to obtain an overview of the types and characteristics of these ADRs. RESULTS: Of 3114 ADRs notified to the FPVD during the COVID-19 period in 2020, 114 (3.7%) were linked to self-medication. The equivalent proportion in 2019 was 1.6% (113 out of 7097). Half of the ADRs notified in 2020 were "serious". The median age of affected patients was 30.5, and 22% of the ADRs concerned children. Of the 114 ADRs linked to self-medication, 107 (66%) were for prescription-only drugs. The three mostly frequently suspected ATC classes were analgesics, psycholeptics, and antibacterials for systemic use. The most frequent ADRs were general disorders, gastrointestinal disorders, and nervous system disorders. The main difference between the non-COVID-19 period and the COVID-19 period was the higher proportion of medication errors during the latter. CONCLUSION: The present study is the first to have reported on ADRs linked to self-medication and notified during a COVID-19 outbreak. Further studies of self-medication patterns and their consequences in a pandemic context are mandatory and effective information on medication use (including self-medication and its dangers) during a pandemic is essential.
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Sistemas de Registro de Reacción Adversa a Medicamentos , COVID-19 , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Pandemias , Automedicación/efectos adversos , Autoinforme , Accidentes , Adolescente , Niño , Preescolar , Sobredosis de Droga/epidemiología , Francia , Humanos , Errores Médicos , FarmacovigilanciaRESUMEN
Lithium intoxication may induce neurological complications, initially characterised by a conscience alteration and an encephalopathy clinical picture with a risk of death or sever long-term consequences. With an occurrence sometimes atypical and possibly without initial hyperlitemia, the diagnosis delay of these complications might be important. Moreover, no specific guidelines focused on these complications are available. The aim of this article is to propose an update on diagnosis and treatment of neurological complications attributable to lithium, as encephalopathy.
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Trastorno Bipolar , Encefalopatías , Enfermedades del Sistema Nervioso , Trastorno Bipolar/inducido químicamente , Trastorno Bipolar/diagnóstico , Trastorno Bipolar/tratamiento farmacológico , Encefalopatías/inducido químicamente , Encefalopatías/diagnóstico , Humanos , Litio/efectos adversos , Enfermedades del Sistema Nervioso/inducido químicamente , Enfermedades del Sistema Nervioso/diagnósticoRESUMEN
INTRODUCTION: Cancer therapy has greatly progressed in the past few years, due to development of immune checkpoint proteins. These immunotherapies, when applied to eligible patients, have significantly reduced mortality but are prone to induce immune side-effects, including pituitary disorder and low adreno-corticotropic hormone (ACTH) and cortisol levels. We aimed to assess the prevalence and etiology of corticotropic insufficiency through a systematic screening of cortisol and ACTH levels in patients with lung cancer treated with nivolumab perfusion. MATERIAL AND METHODS: All patients from our Center with indications for nivolumab treatment for pulmonary squamous cell carcinoma or adenocarcinoma resistant to chemotherapy were successively included and underwent cortisol and ACTH assay before each nivolumab perfusion. When cortisol was below normal without ACTH elevation, we screened for pituitary metastasis, hypophysitis or corticosteroid treatment that could explain the corticotropic insufficiency. RESULTS: Data from 75 patients (80.0% men, 20.0% women) showed 10.7% asymptomatic corticotropic insufficiency, with a mean cortisol level of 2.76±1.27µg/dl. Diagnosis was made during the first 2 months of nivolumab treatment in 88% of cases. Corticosteroid treatment explained the low cortisol level in 25.0% of cases. No pituitary metastases were found. Hypophysitis was suspected in 75.0% of cases. CONCLUSION: In a 75-patient cohort with non-small cell lung cancer treated with the PD1 antibody nivolumab and systematically screened for cortisol abnormalities, 10.7% of patients showed asymptomatic corticotropic insufficiency. Excluding corticotropic insufficiency secondary to corticosteroid treatment, 8.0% of patients presented cortisol level<5µg/dl attributed to hypophysitis. Cortisol screening enables hydrocortisone replacement treatment to be prescribed if necessary, preventing risk of adrenal crisis.
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Hormona Adrenocorticotrópica/deficiencia , Carcinoma de Pulmón de Células no Pequeñas , Hipofisitis/epidemiología , Hipofisitis/etiología , Neoplasias Pulmonares , Insuficiencia Suprarrenal/sangre , Insuficiencia Suprarrenal/epidemiología , Insuficiencia Suprarrenal/etiología , Hormona Adrenocorticotrópica/sangre , Anciano , Carcinoma de Pulmón de Células no Pequeñas/sangre , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Carcinoma de Pulmón de Células no Pequeñas/epidemiología , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Francia/epidemiología , Humanos , Hidrocortisona/sangre , Hipofisitis/sangre , Neoplasias Pulmonares/sangre , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/epidemiología , Masculino , Persona de Mediana Edad , Nivolumab/uso terapéutico , Prevalencia , Estudios Prospectivos , Factores de RiesgoRESUMEN
INTRODUCTION: The registration of adverse events after the use of immunological veterinary medicinal products (IVMP) is the aim of the vigilance reporting system in Switzerland. Adverse events comprise suspected adverse reactions and lack of expected efficacy. Since the Institute of virology and immunology (IVI) is the competent authority for the regulation of immunological VMP in Switzerland, the reporting system is administrated by the IVI. In 2019, 137 reports concerning authorized immunological VMP were received (15% less compared to 2018). While most of the reports were submitted by the marketing authorization holders (56%), practicing veterinary surgeons contributed to the reporting system, too (40%). This corresponds to an increase of 22% of reported adverse events by the practicing veterinary surgeons compared to the previous year. Private persons (4%) submitted five reports. In comparison to 2018, in 2019 79% of the adverse events were reported by marketing authorization holders and 18% by veterinarians. Dogs (55%) and cats (20%) were mainly affected. Further reports were related to cattle (13%) and horses (5%). Recently, the numbers of reports concerning dogs (+12%) and cats (+4%) have considerably increased. Most of the reports were based on the application of vaccines against canine distemper, hepatitis, parvovirosis and parainfluenza in combination with leptospirosis in dogs as well as cat flu and feline panleukopenia in cats. In 34% of the submitted cases, the causality assessment between the vaccination and the reaction described was evaluated as probable.
INTRODUCTION: L'enregistrement des effets indésirables après utilisation de médicaments vétérinaires immunologiques est l'objectif du système de notification de vigilance en Suisse. Les effets indésirables comprennent les effets indésirables suspectés et le manque quant à l'efficacité attendue. L'Institut de virologie et d'immunologie (IVI) étant l'autorité compétente pour la réglementation des produits vétérinaires immunologiques en Suisse, le système de déclaration est administré par l'IVI. En 2019, 137 rapports concernant des produits vétérinaires immunologiques autorisées ont été reçus (15% de moins par rapport à 2018). Alors que la plupart des rapports ont été soumis par les titulaires de l'autorisation de mise sur le marché (56%), les vétérinaires en exercice ont également contribué au système de déclaration (40%). Cela correspond à une augmentation de 22% des effets indésirables rapportés par les vétérinaires en exercice par rapport à l'année précédente. Des particuliers (4%) ont soumis cinq rapports. Par rapport à 2018, en 2019, 79% des effets indésirables ont été signalés par les titulaires d'AMM et 18% par des vétérinaires. Les chiens (55%) et les chats (20%) ont été principalement concernés. D'autres rapports concernaient des bovins (13%) et des chevaux (5%). Récemment, le nombre de signalements concernant les chiens (+12%) et les chats (+4%) a considérablement augmenté. La plupart des rapports étaient basés sur l'application de vaccins contre la maladie de Carré, l'hépatite, la parvovirose et la parainfluenza en association avec la leptospirose chez le chien ainsi que contre la grippe et la panleucopénie féline chez le chat. Dans 34% des cas soumis, l'évaluation de la causalité entre la vaccination et la réaction décrite a été jugée probable.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/veterinaria , Medicina Veterinaria/estadística & datos numéricos , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Animales , SuizaRESUMEN
INTRODUCTION: Idiosyncratic drug-induced agranulocytosis is a rare but potentially serious haematological disorder. The pathophysiological mechanisms are complex and poorly understood. We aimed at investigating agranulocytosis drug related causes from the myelograms with "myeloid maturation arrest" performed in our university hospital over the last seven years. METHODS: A retrospective analysis of myelograms collected for agranulocytosis was performed from 1st January 2010 to 31th December 2016. We used the method of Bégaud et al. for drug causality assessment. RESULTS: Among the 104 myelograms analysed, 41 agranulocytosis were drug-induced, whose 28 were idiosyncratic. Among these 28 cases, 26 different drugs were involved. Agranulocytosis was a known adverse reaction in the summary of the product characteristics for 24 drugs, mainly associated with undetermined frequency (n=7). Mean onset latency was 38.1 days after starting the drug (calculated for n=23 cases) and granulocyte growth factors were used in 50% of cases without shortening the mean delay of blood count recovery. Bone marrow presented hypereosinophilia in 29% of cases. Pharmacovigilance reporting rate was 48%. CONCLUSION: A "maturation arrest" in the myelogram is not pathognomonic for idiosyncratic drug-induced agranulocytosis. This rare event require multidisciplinary care involving haematologists, biologists and pharmacovigilance experts. Agranulocytosis reporting rate was high compared with usual adverse drug reaction reporting rate (5 to 10%), probably related to the potential severity of this event.
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Agranulocitosis/inducido químicamente , Hospitales Universitarios , Adulto , Anciano , Anciano de 80 o más Años , Agranulocitosis/epidemiología , Recuento de Células Sanguíneas , Médula Ósea/patología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Femenino , Francia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Mielografía , Farmacovigilancia , Estudios Retrospectivos , Adulto JovenRESUMEN
OBJECTIVES: Many transfused patients present severe, sometimes critical, clinical conditions. The occurrence of adverse transfusion reactions may cause the clinical condition to deteriorate. A study was conducted aimed at establishing whether the presence of neurological signs during an adverse transfusion reaction increases its severity. METHODS: From 1 January 2010 to 30 June 2019, adverse reactions with neurological signs were extracted from the French haemovigilance database system. Two signs observed at the time of the reaction were analysed: unconsciousness and convulsions. Stroke was excluded. The type of reaction, its severity, the blood product involved and its imputability were all studied. RESULTS: During the study period, 10,670 reactions were reported, including 20 (0.19%) imputed to the transfusion with unconsciousness and/or convulsions. Unconsciousness without convulsions was frequently observed (14 reports, 70.0%). Convulsions were reported in 5 cases (25.0%), with 1 case being associated with unconsciousness. Unconsciousness and/or convulsions were present in 9 allergic reactions (45.0%) and 4 transfusion-associated circulatory overloads (20.0%). Nine reactions were severe (45.0%), 7 were life-threatening (35.0%) and 1 case resulted in the recipient's death (5.0%). A red blood cell and a platelet concentrate transfusion were involved in 8 reactions (40.0%) each, although the imputability of the blood product was certain in only 2 of the reactions. CONCLUSION: Unconsciousness and/or convulsions were rarely observed in adverse reactions reported in transfused patients. Nevertheless, the presence of these signs highlights the severity of the adverse reactions (17 reactions, 85.0%).
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Hipersensibilidad , Reacción a la Transfusión , Seguridad de la Sangre , Transfusión Sanguínea , Eritrocitos , HumanosRESUMEN
Transfusion in paediatrics requires specific guidelines, because child physiology and pathology differ significantly as compared to adults. Adverse transfusion reactions in transfused children also vary in type and frequency, but there is a better understanding of these reactions in adults than in children. However, for the most frequent adverse transfusion reactions, the overall prevalence is higher in children than in adults, with the exception of post-transfusion red blood cell alloimmunisation, which is lower, excluding patients with haemoglobinopathies. In several studies, allergic reactions were the most frequently reported adverse transfusion reaction in paediatrics, and the platelet concentrate the most frequently implicated blood product. Early diagnosis of certain adverse transfusion reactions such as haemosiderosis, is essential in order to initiate the best therapy and obtain a good clinical outcome. The prevention of adverse transfusion reactions in children is required, but needs further clinical studies in paediatrics. Lastly, changes in technology, policy and clinical practices will improve transfusion safety in children.