RESUMEN
BACKGROUND: Growing evidence indicates that amoxicillin induces herpesvirus replication in vitro. As these play a central pathophysiological role in Drug Reaction with Eosinophilia and Systemic Symptoms syndrome (DRESS), amoxicillin could present with specific DRESS features. OBJECTIVE: To characterize the onset patterns of amoxicillin-associated DRESS. METHODS: All cases of DRESS (Kardaun score ≥4) involving amoxicillin and reported in the French Pharmacovigilance Database between January 1, 2004 and November 30, 2019 were included. Onset circumstances for these cases were categorized considering the onset delay from amoxicillin initiation, and the presence of concomitant medications with a compatible time to onset. RESULTS: A total of 146 probable cases or definite cases of DRESS were included. Three onset circumstances were identified: (i) 'amoxicillin clear culprit' where amoxicillin was the sole suspect drug or when concomitant drugs of compatible time to onset were not reported to cause DRESS (n = 62); (ii) 'amoxicillin possible culprit' in the presence of other potentially culprit drugs in addition to amoxicillin (n = 44) and (iii) 'flare' where amoxicillin, used after DRESS onset, induced flare-up reactions (n = 40). The median time to onset was 5 days (IQR 2-11) in 'clear culprit', and 18 days (IQR 7-26) in 'possible culprit' cases. In 'flare' cases, the median latency between amoxicillin initiation and flare-up reactions was 3 days (IQR 2-5). CONCLUSIONS: Amoxicillin can induce DRESS with a specific early onset and exacerbate DRESS from another drug.
Asunto(s)
Síndrome de Hipersensibilidad a Medicamentos , Eosinofilia , Amoxicilina/efectos adversos , Bases de Datos Factuales , Síndrome de Hipersensibilidad a Medicamentos/epidemiología , Síndrome de Hipersensibilidad a Medicamentos/etiología , Eosinofilia/inducido químicamente , Humanos , FarmacovigilanciaAsunto(s)
Amitriptilina/efectos adversos , Analgésicos no Narcóticos/efectos adversos , Industria Farmacéutica/tendencias , Trastornos Migrañosos/prevención & control , Topiramato/efectos adversos , Adolescente , Adulto , Factores de Edad , Amitriptilina/administración & dosificación , Analgésicos no Narcóticos/administración & dosificación , Antiinflamatorios no Esteroideos/administración & dosificación , Antiinflamatorios no Esteroideos/efectos adversos , Anticonvulsivantes/administración & dosificación , Anticonvulsivantes/efectos adversos , Niño , Úlcera Duodenal/tratamiento farmacológico , Femenino , Francia , Reflujo Gastroesofágico/tratamiento farmacológico , Humanos , Masculino , Farmacovigilancia , Fenitoína/administración & dosificación , Fenitoína/efectos adversos , Fenitoína/análogos & derivados , Sustitutos del Plasma/administración & dosificación , Sustitutos del Plasma/efectos adversos , Poligelina/administración & dosificación , Poligelina/efectos adversos , Inhibidores de la Bomba de Protones/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Factores Sexuales , Úlcera Gástrica/tratamiento farmacológico , Topiramato/administración & dosificaciónAsunto(s)
Antagonistas Adrenérgicos beta/uso terapéutico , Bloqueadores del Receptor Tipo 1 de Angiotensina II/uso terapéutico , Fármacos Antiobesidad/efectos adversos , Anticonvulsivantes/efectos adversos , Aorta/efectos de los fármacos , Aneurisma de la Aorta/prevención & control , Atenolol/uso terapéutico , Fisura del Paladar/inducido químicamente , Fructosa/análogos & derivados , Hemangioma/congénito , Hemangioma/epidemiología , Losartán/uso terapéutico , Síndrome de Marfan/tratamiento farmacológico , Efectos Tardíos de la Exposición Prenatal , Neoplasias Cutáneas/congénito , Neoplasias Cutáneas/epidemiología , Femenino , Humanos , Masculino , EmbarazoAsunto(s)
Antiinflamatorios/efectos adversos , Anticonvulsivantes/efectos adversos , Peso al Nacer/efectos de los fármacos , Sistema Inmunológico/efectos de los fármacos , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Adalimumab , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales Humanizados/efectos adversos , Susceptibilidad a Enfermedades , Femenino , Fructosa/efectos adversos , Fructosa/análogos & derivados , Humanos , Sistema Inmunológico/embriología , Recién Nacido , Infecciones/etiología , Infliximab , Embarazo , Efectos Tardíos de la Exposición Prenatal , TopiramatoRESUMEN
Lenalidomide is an immunomodulating drug structurally similar to thalidomide. It is indicated for patients with relapsing or refractory multiple myeloma in combination with dexamethasone, and for patients with myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality. It is also used to treat other myelodysplastic syndromes such as myelofibrosis and lymphoma. We report a case of organizing pneumonia leading to acute respiratory distress syndrome (ARDS) after long-term administration of lenalidomide, along with a review of the literature.
Asunto(s)
Factores Inmunológicos/efectos adversos , Síndrome de Dificultad Respiratoria/inducido químicamente , Talidomida/análogos & derivados , Humanos , Lenalidomida , Pulmón/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Mielofibrosis Primaria/tratamiento farmacológico , Síndrome de Dificultad Respiratoria/diagnóstico por imagen , Talidomida/efectos adversos , Tomografía Computarizada por Rayos XRESUMEN
Drug safety in children must take into account the frequency of « off label ¼ prescriptions, children's growth dynamics, and possible long-term consequences (growth, neurodevelopment). The pharmacovigilance methodology is based on spontaneous notification and pharmacoepidemiology studies usually included the in risk management plan. Despite an increased drug risk (pharmacokinetic and pharmacodynamic specificities), drug safety is better in children than in adults. The incidence of drug side effects depends on the country, the type of study (in or out of the hospital), and age. Antibiotics, central nervous, respiratory and dermatologic drug systems are most often involved. The target organs are gastrointestinal and neurologic. In neonates, the most frequent side effects are due to pregnancy exposure to psychotropic drugs, beta-blockers, and antiepileptics. Some studies have shown an increased risk of off-label prescriptions in children. During the last 6 years in France, pediatric alerts (desmopressin, metoclopramide, bronchial mucolytic drugs, first-generation anti-H1, Uvesterol D(®), and Uvesterol A.D.E.C(®), rotavirus vaccines, growth hormone, cisapride) have been less frequent than in adults.
Asunto(s)
Farmacovigilancia , Sistemas de Registro de Reacción Adversa a Medicamentos , Niño , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , Lactante , Uso Fuera de lo IndicadoAsunto(s)
Enfermedades Cerebelosas/inducido químicamente , Quelantes del Hierro/efectos adversos , Sobrecarga de Hierro/tratamiento farmacológico , Piridonas/efectos adversos , Niño , Deferiprona , Femenino , Humanos , Quelantes del Hierro/administración & dosificación , Masculino , Piridonas/administración & dosificación , Talasemia beta/tratamiento farmacológicoAsunto(s)
Antihipertensivos/efectos adversos , Neoplasias de la Coroides/inducido químicamente , Melanoma/inducido químicamente , Prostaglandinas F Sintéticas/efectos adversos , Neoplasias Cutáneas/inducido químicamente , Anciano de 80 o más Años , Antihipertensivos/administración & dosificación , Neoplasias de la Coroides/patología , Femenino , Humanos , Latanoprost , Melanoma/patología , Persona de Mediana Edad , Prostaglandinas F Sintéticas/administración & dosificación , Neoplasias Cutáneas/patologíaRESUMEN
INTRODUCTION: Temozolomide is an alkylating agent approved for treatment of glioblastoma in association with radiotherapy. CASE REPORT: We report the case of a 56 year old woman presenting with alveolo-interstitial pneumonia after treatment with Temozolomide. Initially she received induction treatment with Temozolomide and concomitant radiotherapy for bifocal high grade glioblastoma. A month later she received, as scheduled, the first course of Temozolomide maintenance chemotherapy. Grade II dyspnoea developed a few days later. High resolution computed tomography showed alveolo-interstitial opacities with basal predominance, associated with alveolar nodules. Broncho-alveolar lavage showed a lymphocytosis. No bacteria were isolated from microbiological samples. A final diagnosis of drug-induced pneumonia was based on the time sequence and absence of other causes. CONCLUSION: There is little literature concerning the pulmonary toxicity of Temozolomide. However, our case report of drug-induced pneumonia and similar observations in the databases of regional pharmacovigilance centres suggest that this side effect should be included in the summary of product characteristics.
Asunto(s)
Antineoplásicos Alquilantes/efectos adversos , Dacarbazina/análogos & derivados , Enfermedades Pulmonares Intersticiales/inducido químicamente , Neoplasias Encefálicas/tratamiento farmacológico , Lavado Broncoalveolar , Dacarbazina/administración & dosificación , Dacarbazina/efectos adversos , Femenino , Glioblastoma/tratamiento farmacológico , Humanos , Enfermedades Pulmonares Intersticiales/diagnóstico por imagen , Linfocitosis , Persona de Mediana Edad , Radiografía Torácica , Temozolomida , Factores de Tiempo , Tomografía Computarizada por Rayos XRESUMEN
Safety of vaccines must be excellent to make vaccine's strategy acceptable, since it usually has a deferred individual benefit but immediate adverse drug reactions (ADRs). Pharmacovigilance of vaccines after their marketing is crucial because, prior to its availability on the market, the size of clinical trials is insufficient to identify rare or deferred adverse effects. The Pharmacovigilance is based on "spontaneous reporting" of ADRs to the Pharmacovigilance Regional Centre (PVRC) which establishes a relationship between each drug taken by the patient and the ADRs occurrence (imputability). This method is crucial to generate alerts, but under-estimates the real frequency of ADRs (1 to 10% of severe ADRs are reported). Thus pharmacoepidemiology studies are necessary to confirm the alerts identified by spontaneous reporting. ADRs can be specific, related to the antigen of an attenuated alive virus vaccine (lymphocyte meningitis after anti-mumps vaccine) or non-specific, related to a component different from the antigen (aluminium hydroxide involved in the "macrophagic myofasciitis", allergic reactions to neomycin, latex, egg or gelatine). Importance of Pharmacovigilance of vaccines is illustrated. Data, especially case-control studies, about the relationship between multiple sclerosis and hepatitis B vaccine are summarised. Data about the relationship between Crohn's disease or autism and MMR vaccine are analysed. As vaccines are used in healthy people, their safety must be excellent to be accepted. To monitor them after their marketing is the unique way to detect rare ADRs. This surveillance is made through reporting of ADRs to the PVRC. However, an active and intensive surveillance of ADRs as the one set up from the marketing of Prevenar should be systematic.