Sospecha de reacciones adversas a la vacuna triple vírica notificadas al Centro de Farmacovigilancia de la Comunidad Valenciana / Suspected adverse events to measles, mumps and rubella vaccine reported to the Community of Valencia Pharmacovigilance Centre

Introducción: El sistema de Farmacovigilancia de Medicamentos de Uso Humano constituye un importante mecanismo para el seguimiento postautorización de la seguridad de las vacunas. La vacuna triple vírica es una vacuna combinada de virus vivos atenuados de sarampión, rubéola y parotiditis. A pesar de que los episodios adversos asociados son considerados generalmente leves, la vacuna ha sido ampliamente cuestionada. Nuestro objetivo fue describir las notificaciones de sospecha de reacciones adversas relacionadas con esta vacuna, realizadas al Centro de Farmacovigilancia de la Comunidad Valenciana. Material y métodos: Estudio descriptivo a partir de los casos notificados entre el 15 de mayo de 2005 y el 15 de mayo de 2010.Tras agrupar las sospechas de reacciones adversas por criterios diagnósticos, fue realizado un análisis descriptivo de las variables. Resultados: Tras la administración de 545.830 dosis fueron notificadas 96 sospechas de reacciones adversas (1,76 notificaciones/100.000 dosis), que incluyeron un total de 181 reacciones. Las reacciones descritas con más frecuencia fueron fiebre (42,7%) e inflamación en la zona de inyección (36,5%). Fueron clasificadas como graves el 8,3% de las notificaciones. En todos los casos la recuperación fue completa. Conclusiones: Las sospechas de reacciones adversas notificadas coinciden con las reacciones descritas en las fichas técnicas de las vacunas. La frecuencia de notificaciones es notablemente inferior a la descrita en la literatura, no obstante, a pesar de las probables limitaciones y con los datos obtenidos podemos afirmar que la vacuna triple vírica ofrece un buen perfil de seguridad, acorde con los datos publicados hasta ahora (AU)

Introduction: A Pharmacovigilance system is an important tool for post-marketing monitoring on vaccine safety. Measles, mumps, rubella (MMR) vaccine is a combined vaccine of live attenuated virus. Since its approval, and although the adverse events are considered generally mild, the vaccine has been widely questioned for the controversies arising around its safety. Our objective was to describe suspected adverse events related to MMR vaccine reported to the Valencian Pharmacovigilance Centre. Material and methods: Descriptive study from cases reported between May 15th, 2005 and May 15th, 2010. After grouping the suspected adverse events by diagnostic criteria, a descriptive analysis of variables was performed. Results: After 545,830 doses administered, 96 notifications were reported (1.76 notifications/100,000 doses) including 181 adverse events. Fever (42.7%) and local inflammation (36.5%) were the most reported events. There were 8.3% notifications classified as severe. Recovery was complete in all cases. Conclusions: The suspected adverse events reported coincided with those described in the Summary of Product Characteristics of the vaccine. The frequency of reports was lower than previously published estimates. Despite the limitations, the data obtained allowed us to conclude that MMR vaccine has a good safety profile, according to previously published studies (AU)

[Suspected adverse events to measles, mumps and rubella vaccine reported to the Community of Valencia Pharmacovigilance Centre]. / Sospecha de reacciones adversas a la vacuna triple vírica notificadas al Centro de Farmacovigilancia de la Comunidad Valenciana.

INTRODUCTION: A Pharmacovigilance system is an important tool for post-marketing monitoring on vaccine safety. Measles, mumps, rubella (MMR) vaccine is a combined vaccine of live attenuated virus. Since its approval, and although the adverse events are considered generally mild, the vaccine has been widely questioned for the controversies arising around its safety. Our objective was to describe suspected adverse events related to MMR vaccine reported to the Valencian Pharmacovigilance Centre. MATERIAL AND METHODS: Descriptive study from cases reported between May 15th, 2005 and May 15th, 2010. After grouping the suspected adverse events by diagnostic criteria, a descriptive analysis of variables was performed. RESULTS: After 545,830 doses administered, 96 notifications were reported (1.76 notifications/100,000 doses) including 181 adverse events. Fever (42.7%) and local inflammation (36.5%) were the most reported events. There were 8.3% notifications classified as severe. Recovery was complete in all cases. CONCLUSIONS: The suspected adverse events reported coincided with those described in the Summary of Product Characteristics of the vaccine. The frequency of reports was lower than previously published estimates. Despite the limitations, the data obtained allowed us to conclude that MMR vaccine has a good safety profile, according to previously published studies.

Gastroenteritis vírica en niños hospitalizados. Estudio prospectivo multicéntrico / Viral gastroenteritis in hospitalized children. A multicentre prospective study

Introducción: El objetivo de este estudio fue determinar prospectivamente la etiología vírica de la gastroenteritis aguda (GEA) en lactantes hospitalizados, así como describir las características clínicas de los principales virus. Pacientes y métodos: Desde octubre de 2006 hasta marzo de2007, se realizó el seguimiento de todos los niños de 1-23 meses de edad hospitalizados en tres hospitales, desde el momento de la admisión hasta las 72 horas tras el alta, para detectarla presencia de GEA. Se analizó una muestra de heces de los niños con GEA para la detección de rotavirus, calicivirus (norovirus y sapovirus), astrovirus y adenovirus mediante transcripción inversa y reacción en cadena de la polimerasa. Resultados: De un total de 1.576 pacientes hospitalizados, se pudo realizar el seguimiento de 1.300 (82,5%), que han constituido nuestra cohorte de estudio. Un total de 242 niños tuvieron GEA (un 18,6% de la cohorte), obteniéndose muestra de heces de 217 (89,7%). En 91 casos (42%) se detectaron rotavirus, en 72 norovirus (33,2%), en 7 astrovirus (3,2%) y en2 adenovirus; no se detectó sapovirus en ningún caso. Trece niños (6%) presentaron infecciones mixtas por dos o más virus, y 32 (14,7%) resultaron negativos para todos los virus analizados. En los casos de GEA por norovirus se observa menor apatía y pérdida de peso que en los casos de rotavirus, pero mayorporcentaje de heces con sangre.Conclusiones: Los virus son una causa frecuente de GEA enlos niños menores de 2 años hospitalizados; el principal virus hallado es el rotavirus, seguido del norovirus. Debido a las escasas diferencias clínicas observadas entre rotavirus y norovirus, es necesaria su determinación analítica para su diferenciación (AU)

Introduction: The objective of this study was to determine prospectively the viral etiology of acute gastroenteritis (AGE) in hospitalized weaning babies and describe the clinical characteristics of the principal virus detected. Patients and methods: All children aged 1 to 23 months admitted to 3 hospitals during October 2006-March 2007 were followed for the presence of AGE from the time of hospital admission until 72 hours after hospital discharge. A stool sample of children with AGE was tested for calicivirus (norovirus and sapovirus), rotavirus, adenovirus and astrovirus by RT-PCR. Results: Of the 1,576 hospitalized children, 1,300 (82.5%)were fully monitored being our study cohort. A total of 242children had AGE (18.6% of the cohort) and stool samples from217 children were obtained (89.7%). In 91 cases (42%) were positive to rotavirus, 72 (33.2%) to norovirus, 7 (3.2%) to astrovirus, and in 2 to adenovirus, not detecting sapovirus in any case, 13 children (6%) showed mixed infections by two or more viruses and 32 (14.7%) cases were negative for the analyzed virus. Norovirus AGE have less apathy and weight loss than thecases of rotavirus but a higher percentage of stools with blood. Conclusions: The viruses are a frequent cause of AGE among the hospitalized children of less than 2 years of age being rotavirus the principal virus found followed by norovirus. Few clinical differences were observed between rotavirus and norovirus and analytical determination is necessary for their differentiation (AU)

Gastroenteritis aguda por rotavirus. Un problema en nuestros hospitales / Acute gastroenteritis due to rotavirus. A problem in our hospitals

La gastroenteritis aguda provocada por rotavirus es un problema constante cada invierno debido a que existe un elevado porcentaje de pacientes pediátricos hospitalizados en un periodo en el que, además, suele haber un aumento de los ingresos hospitalarios por otras patologías, como la bronquiolitis debida al virus respiratorio sincitial y la gripe; ello acaba ocasionando una sobrecarga asistencial y el hacinamiento de los niños y familiares en los servicios de pediatría, por lo que aumenta el riesgo de contagio al resto de niños hospitalizados. El rotavirus es un virus muy infectivo y con una elevada variabilidad antigénica, en el que se detectan importantes variaciones en la distribución de los genotipos circulantes entre diferentes poblaciones o periodos de tiempo. Su tratamiento es principalmente sintomático y, a pesar de que existen diferentes medidas de prevención frente a esta patología, la más destacada es la utilización de vacunas seguras y eficaces (AU)

Rotavirus acute gastroenteritis is a constant problem each winter due to the high percentage of pediatric patients hospitalized during a period of time which coincides besides with the hospital admission for other pathologies as bronchiolitis due to the Respiratory Syncytial Virus (RSV) and influenza, causing the assistance overload and the overcrowding of children and relatives in the pediatric wards, which poses a major risk of virus transmission among hospitalized children. Rotavirus is a very infectious virus and has a high antigenic variability with important variations detected in the distribution of the circulating genotypes among different populations or periods of time. Its treatment is mainly symptomatic and in spite of the fact that different measures of prevention exist against this pathology the most outstanding is the use of safe and effective vaccines (AU)