Salud
Dosis potencialmente peligrosas de melatonina y CBD encontradas en gomitas vendidas para dormir
Según un nuevo estudio, las pruebas de más de dos docenas de «gomitas» de melatonina vendidas como somníferos encontraron que algunas tenían cantidades potencialmente peligrosas de la hormona que ayuda a regular el sueño.
“Un producto contenía un 347 % más de melatonina de lo que realmente figuraba en la etiqueta de las gomitas”, dijo el coautor del estudio, el Dr. Pieter Cohen, profesor asociado de medicina en Cambridge Health Alliance en Somerville, Massachusetts.
Un frasco de gomitas también podría contener ingredientes con los que no contabas, dijo Cohen: “Uno de los productos que enumeraban la melatonina no contenía melatonina en absoluto. Era solo cannabidiol o CBD”.
Según la Administración de Drogas y Alimentos de EE. UU ., «actualmente es ilegal comercializar CBD agregándolo a un alimento o etiquetándolo como un suplemento dietético». Sin embargo, varios de los productos probados que contenían CBD en el estudio anunciaron abiertamente la adición de ese compuesto a su producto de melatonina, dijo Cohen.
“Cuatro de los productos probados contenían niveles de CBD entre un 4 % y un 18 % más altos que en la etiqueta”, dijo Cohen.
El uso de CBD en ayudas de venta libre es particularmente preocupante porque los padres pueden comprar productos gomosos para dárselos a sus hijos y ayudarlos a dormir, dijo la Dra. Cora Collette Breuner, profesora de pediatría en el Hospital Infantil de Seattle en la Universidad de Washington. .
“No hay datos que respalden el uso de CBD en niños”, dijo Breuner, quien no participó en el estudio. «Actualmente solo se recomienda para un uso muy específico en niños mayores de 1 año con trastornos convulsivos intratables».
Además del CBD, consumir una gomita que, sin saberlo, contiene niveles extremadamente altos de melatonina, muy por encima de los 0,5 a 1 miligramo diarios por noche que se ha demostrado que induce el sueño en los niños, también es peligroso, dijo Breuner, quien forma parte del comité de medicina integrativa de la Academia Estadounidense de Pediatría, que actualmente está escribiendo nuevas pautas sobre suplementos en niños.
Los efectos secundarios del uso de melatonina en los niños pueden incluir somnolencia, dolores de cabeza, agitación y aumento de la enuresis nocturna o de orinar por la noche. También existe la posibilidad de interacciones dañinas con medicamentos y reacciones alérgicas a la melatonina, según el Centro Nacional de Salud Complementaria e Integrativa , un departamento de los Institutos Nacionales de Salud.
La agencia también advierte que los suplementos podrían afectar el desarrollo hormonal, “incluyendo la pubertad, los ciclos menstruales y la sobreproducción de la hormona prolactina”, que provoca el desarrollo de los senos y la leche en las mujeres.
Elegido cuidadosamente de la base de datos del gobierno
En el estudio, publicado el martes en la revista JAMA , los investigadores enviaron 25 productos etiquetados como gomitas de melatonina a un laboratorio externo que analizó los niveles de melatonina y otras sustancias.
Sin embargo, el equipo de investigación no escogió productos de Internet «al azar», dijo Cohen. Los científicos eligieron cuidadosamente los primeros 25 productos de melatonina gomosa que se muestran en la base de datos de los Institutos Nacionales de Salud , que el público puede consultar para ver las etiquetas de los suplementos dietéticos que se venden en los Estados Unidos.
“Elegimos gomitas sobre otros productos porque pensamos que los padres elegirían comestibles para dar a sus hijos”, dijo Cohen. «»También queríamos echar un vistazo más de cerca a esos productos después del informe del año pasado de que los centros de envenenamiento han recibido más de un cuarto de millón de llamadas sobre ingestión pediátrica, miles de hospitalizaciones, visitas a la UCI e incluso algunas muertes».
Un informe de 2022 de los Centros para el Control y la Prevención de Enfermedades de EE. UU. encontró que las llamadas al control de intoxicaciones sobre la ingestión de melatonina por parte de los niños aumentaron un 530 % entre 2012 y 2021. El mayor aumento en las llamadas (38 %) ocurrió entre 2019 y 2020, según el informe.
La mayoría de las llamadas eran sobre niños menores de 5 años que accidentalmente habían comido gomitas que los cuidadores no habían guardado bajo llave.
“Las gomitas atraen a los niños pequeños, que las ven como dulces”, dijo Cohen. “Nos preguntamos si estaba pasando algo con los productos que podrían estar contribuyendo a las llamadas a los centros de control de envenenamiento”.
El nuevo estudio encontró que el 88 % de las gomitas estaban mal etiquetadas, y solo tres contenían una cantidad de melatonina que estaba dentro del 10 % de lo que figuraba en la etiqueta, dijo Cohen, quien ha estudiado el etiquetado no válido de suplementos durante años.
“El marco regulatorio para los suplementos está roto”, dijo, “los fabricantes no cumplen con la ley y la FDA no la hace cumplir. Entonces, lo que eso significa es que tenemos muchos productos de mala calidad”.
Un portavoz de la FDA le dijo a CNN que la agencia revisaría los hallazgos del estudio y agregó que la FDA generalmente no comenta sobre estudios específicos, sino que “los evalúa como parte del cuerpo de evidencia para mejorar nuestra comprensión sobre un tema en particular. ”
«Es importante subrayar que, según la ley actual, la FDA no tiene la autoridad para aprobar suplementos dietéticos antes de que se comercialicen, y las empresas tienen la responsabilidad principal de asegurarse de que sus productos no estén adulterados o mal etiquetados antes de distribuirlos», dijo el vocero. dijo vía correo electrónico.
Steve Mister, presidente y director ejecutivo del Consejo para la Nutrición Responsable, una asociación comercial para la industria de suplementos dietéticos, emitió un comunicado en el que afirma que los fabricantes pueden agregar melatonina adicional para asegurarse de que el producto permanezca en los niveles indicados en la etiqueta, ya que la degradación ocurre naturalmente con el tiempo. .
“Si bien puede haber cierta variabilidad en los excedentes a medida que las empresas se adhieren a los requisitos de la FDA con respecto a la vida útil y la potencia, eso no significa que exista un riesgo al tomar estos productos según lo previsto”, dijo Mister.
La melatonina es una hormona
Las personas a menudo ven la melatonina como un suplemento de hierbas o una vitamina, dicen los expertos. En cambio, la melatonina es una hormona producida por la glándula pineal, ubicada en lo profundo del cerebro, y liberada en el torrente sanguíneo para regular los ciclos de sueño del cuerpo.
Los estudios han encontrado que usar melatonina puede ser útil para inducir el sueño si se usa correctamente (tomar una pequeña cantidad al menos dos horas antes de acostarse), pero el beneficio real es pequeño, dijo Breuner.
En seis ensayos controlados aleatorizados sobre el tratamiento con melatonina en la población pediátrica, dijo, la melatonina redujo el tiempo necesario para conciliar el sueño, en un rango de 11 a 51 minutos.
«Sin embargo, estos fueron estudios muy pequeños con resultados muy variables», dijo Breuner. “Así que les digo a los padres: ‘Realmente están considerando tan solo 11 minutos para disminuir la cantidad de tiempo que le toma a su hijo quedarse dormido’”.
Cualquiera que esté considerando la melatonina debe asegurarse de que la botella tenga el sello de la Farmacopea de los Estados Unidos (USP), que los fabricantes contratan para probar y verificar los productos.
“Si tiene un sello de USP en la etiqueta, puede estar seguro de que el producto está etiquetado con precisión”, dijo Cohen. “Sin embargo, eso no significa que los productos de melatonina vayan a funcionar o que sea una buena idea tomarlos.
“De eso no se trata la USP”, dijo. “Pero al menos la verificación de la etiqueta debería eliminar los problemas que estamos viendo aquí en nuestro estudio”.
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