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Policy Statement
Pediatrics
Volume 108, Number 3
September 2001, pp 776-789
El Paso de medicamentos y otros productos químicos a la leche
materna

AMERICAN ACADEMY OF PEDIATRICS
RESUMEN. La Academia Americana de Pediatría tiene como objetivo incrementar las tasas de
lactancia materna en los Estados Unidos de América. Un motivo común para el cese de la lactancia
materna es el uso de medicación por la madre que lacta y el consejo de su medico que deje de
lactar. Esta declaración fundamentada suministra al pediatra, obstetra y medico de familia el
conocimiento actualizado sobre la excreción de medicamentos en la leche humana. La mayoría de
los medicamentos que se prescriben a la madre que lacta no tiene efecto sobre la lactancia o el
bienestar del niño. Esta información es importante no sólo para proteger a los niños lactados de
efectos adversos de la medicación materna sino porque también permite el efectivo tratamiento
farmacológico de la madre que lacta. Nicotina, Drogas Psicotropas e implantes de silicona son tres
importantes temas revisados en esta declaración.

INTRODUCCION
Una declaración sobre el paso de medicamentos y productos químicos a la leche humana fue publicadapor primera vez en 1983 1, con revisiones en 1989 2 y 1994 3. La información continua disponible. EstaDeclaración actual tiene la intención de revisar la lista de agentes que pasan a través de la leche humana ydescribir los posibles efectos sobre el niño o sobre la lactancia, si se conocen, ( tablas 1-7) Si un productofarmacológico o agente químico no aparece en las tablas, ello no significa que no pase a la leche humanao que no tenga efecto sobre el lactante, ello sólo indica que no hay estudios publicados en la literatura.
Estas tablas deben de asistir al medico en el consejo a la madre que lacta con relación a la lactanciamaterna cuando la madre tiene una condición a consecuencia de la cual el medicamento esta indicado LACTANCIA MATERNA Y EL TABACO
En ediciones previas de esta declaración, el Comité de Medicamentos colocó la nicotina (Tabaquismo) enla Tabla 2, " Drogas de Abuso para la que se describen Efectos adversos sobre el Lactante." Las razonespara colocar nicotina y, de esa manera, Tabaquismo en la Tabla 2 se basaban en la disminución de laproducción de leche y de la ganancia de peso en el niño de la madre fumadora y la exposición del niño alambiente de humo como demostraba la presencia de nicotina y su metabolito primario, cotinina, en laleche humana. 4-12, Existe controversia con respecto a los efectos de nicotina en el tamaño de niño al añode edad.13, 14. En el humo del tabaco hay centenares de componentes; sin embargo, nicotina y sumetabolito cotinina son los marcadores mas frecuentes usados en la exposición al tabaco. La Nicotina noes necesariamente el único componente que puede causar un aumento de enfermedades respiratorias através dela leche materna (incluyendo otitis media) además en el lactante se debe considerar también laexposición al ambiente de humos. La Nicotina esta presente en la leche en concentraciones entre 1.5 a3.0 veces la concentración simultanea del plasma materno, 15 y la eliminación intermedia es similar 60 a90 minutos en la leche y el plasma. 7. No hay evidencia para decir que esta cantidad de nicotina representeun riesgo para la salud del niño.
El Comité de Medicamentos desea apoyar el énfasis de la Academia Americana de Pediatría por elincremento de la lactancia materna en los Estados Unidos. El embarazo y la lactancia son las ocasionesideales para que los médicos recomienden el abandono del tabaco. Debemos aceptar que hay mujeresque son incapaces de abandonar el tabaco. Un estudio informó que, entre mujeres que continuaban fumando y lactando, la incidencia de enfermedades respiratorias agudas era menor que en las madresfumadoras que alimentaban a sus hijos con lactancia artificial 16 Esto puede se debe a que lactar y fumares menos dañino para el niño que el biberón más el hábito del tabaco. El Comité de Medicamentos esperaobtener más datos sobre este tema. El Comité de Medicamentos no ha colocado la nicotina (ytabaquismo) en ninguna de las Tablas pero espera que el interés por la alimentación al pecho de unamadre fumadora servirá como un punto de la discusión acerca del abandono del habito del tabaco entre elpediatra y la madre que va a lactar o que lacta al niño. Sin embargo no se han estudiado suficientementepor el Comité de Medicamentos las fuentes alternativas de nicotina(oral, transcutanea) que ayudan adejar el habito del tabaco para hacer una recomendación a favor o en contra en la mujer que lacta.
DROGAS PSICOTROPAS
Los ansiolíticos, antidepresivos, y neurolépticos se han colocado en la Tabla 4, "Medicamentos en losque el Efecto sobre el niño lactado es desconocido pero puede ser de preocupación." Estos medicamentosaparecen en concentraciones bajas (generalmente con una relación de leche a plasma de 0.5-1.0) en laleche después de la ingestión materna. Como consecuencia de la larga vida media de estos componentesy algunos de sus metabolitos, los niños lactados pueden tener cantidades medibles en su plasma y tejidos,así como en el cerebro. Esto es particularmente importante en niños lactados en los primeros meces de lavida, con inmadurez hepática y de la función renal. Las madres que lactan deben ser informadas que siellas toman uno de estos medicamentos, el niño estará expuesto a ello. A causa de que estosmedicamentos afectan la función de los neurotransmisores en el sistema nervioso en desarrollo y puedeque no sea posible predecir los efectos a plazo largo del desarrollo neurológico IMPLANTES DE SILICONA EN LA MAMA Y LACTANCIA MATERNA
Aproximadamente de 800 000 al 1 millón de mujeres en los Estados Unidos han recibido implantesmamarios que contienen silicona (silicio elemental con lazos químicos al oxígeno) en la cubierta o en elgel interior del implante. Se ha incrementado la preocupación acerca de los posibles efectos al niñolactado si la madre que lacta es portadora de implantes. Esta preocupación se origino en informes quedescribieron disfunción esofágica en 11 niños cuyas madres tenían implantes .17,18. Este hallazgo no hasido confirmado por otros informes. La química de la Silicona es extremadamente compleja; el polímeroimplicado en la cubierta y el interior del injerto de seno se compone de un polímero de silicio alternante yátomos de oxígeno con grupos de metilo conectados a los grupos del oxígeno (methylpolydimethylsiloxane). 19 La longitud del polímero determina si es un sólido, un gel o un liquido. Haysolo unos pocos ejemplos del polímero que hayan sido experimentados en la leche de mujer conimplantes; las concentraciones no son mas elevadas que las muestra de control 20 No hay evidencia en elmomento actual que este polimero sea directamente toxico en los tejidos humanos; sin embargo tambienexiste preocupación de que la toxicidad pueda ser mediada por mecanismo inmunológico. Esto no ha sidotodavía confirmado en humanos. Excepto por el estudio citado arriba, no hay mas informes de problemasclinicos en madres con implantes de silicona 21. Es improbable que el silicio cause problemas porque estapresente en la leche de vaca y de formula en una concentración más alta que en la leche procedente demadre con implantes. 22 La simeticona ( anticolico) tiene una estructura muy semejante al polidimetilsiloxane del seno. Simeticona se ha utilizado por décadas en este país y Europa sin ninguna evidencia detoxicidad en niños. El Comité de Medicamentos no cree que la evidencia disponible actualmentejustifique clasificar los implantes de silicona como una contraindicación de la lactancia materna TERAPIA CON MEDICAMENTOS SOBRE LA MUJER QUE LACTA
Antes de prescribir medicamentos a las mujeres que lactan se debería realizar esta consideración: 1. ¿Es el medicamento absolutamente necesario? Si se precisa el medicamento una consulta entre elpediatra y el medico de la madre puede ser más útil para determinar que opciones escoger . 2. Se debe escoger el medicamento más seguro, por ejemplo, acetaminofen antes que aspirina para laanalgesia.
3. Si hay una posibilidad de que un medicamento pueda presentar un riesgo para el niño, debe tomarseen consideración la medida de las concentraciones plasmáticas en el niño lactado.
4. La exposición al medicamento puede ser disminuida haciendo que la madre tome el medicamentoinmediatamente después de que ella haya amamantado o inmediatamente antes de que el lactante tenga unlargo periodo de sueño Los datos se han obtenido de una búsqueda de la literatura médica. Porque las metodologías usadas paracuantificar los medicamentos mejoran continuamente, esta información requiere actualización frecuente.
Los medicamentos citados en las tablas 1 a 7 están ordenados en orden alfabético por su nombregenérico, los nombres comerciales están disponibles citado en Tablas 1 por 7 en Physicians' DeskReference,23 USP DI 2001: Drug Information for the Health Care Professional, Volume I,24 and USPDictionary of USAN and International Drug Names. La lista de referencia no incluye todos los artículospublicados sobre el tema. Para la traducción Española se ha consultado en Martindale “ The completedrug reference “ 32 edition Pharmaceutical Press 1999 y Catalogo de Especialidades Farmacéuticas.
Consejo General de Colegios Oficiales de Farmacéuticos 2001 Los médicos que encuentren efectos adversos en niños de medicamentos-contaminantes en la lechehumana se les insta a que documenten estos efectos en una comunicación a la Food and DrugAdministration (http://www.fda.gov/medwatch/index.html) y al Comité de Medicamentos. Estacomunicación debe incluir el genérico y los nombres comerciales del medicamento, la dosis de la madrey la posología, la concentración del medicamento en la leche materna y en el plasma del niño relacionadocon el tiempo de la ingestión, el método usado para la identificación del laboratorio, la edad del niño, y delos efectos adversos. Tales informes pueden aumentar sustancialmente el conocimiento de la comunidadpediátrica con relación a la trasferencia de los medicamentos en la leche humana , y los riesgospotenciales o actuales en el lactante.
COMMITTEE ON DRUGS, 2000-2001Robert M. Ward, MD, ChairpersonBrian A. Bates, MDWilliam E. Benitz, MDDavid J. Burchfield, MDJohn C. Ring, MDRichard P. Walls, MD, PhDPhilip D. Walson, MDLIAISONSJohn Alexander, MD Food and Drug Administration AlternateDonald R. Bennett, MD, PhD American Medical Association/United States PharmacopeiaTherese Cvetkovich, MD Food and Drug AdministrationOwen R. Hagino, MD American Academy of Child and Adolescent PsychiatryStuart M. MacLeod, MD, PhD Canadian Paediatric SocietySiddika Mithani, MD Bureau of Pharmaceutical Assessment Health Protection Branch, CanadaJoseph Mulinare, MD, MSPH Centers for Disease Control and PreventionLaura E. Riley, MD American College of Obstetricians and GynecologistsSumner J. Yaffe, MD National Institutes of HealthSECTION LIAISONSCharles J. Coté, MD Section on AnesthesiologyEli O. Meltzer, MD Section on Allergy and ImmunologyCONSULTANTCheston M. Berlin, Jr, MDSTAFF ACKNOWLEDGMENT
The Committee on Drugs would like to thank Linda Watson for her work in referenceidentification, document retrieval, and manuscript preparation.
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391. Bagnell PC, Ellenberg HA. Obstructive jaundice due to a chlorinated hydrocarbon in breast milk. Can Med Assoc J . 1977;117:1047-1048 392. Higginbottom MC, Sweetman L, Nyhan WL. A syndrome of methylmalonic aciduria, homocystinuria, megaloblastic anemia neurologic abnormalities in a vitamin B12-deficient breast-fed infant of a strict vegetarian. N Engl J Med. 1978;299:317-323 TABLA 1
Drogas citotóxicas que pueden interferir con el Metabolismo celular del Niño Lactante
Motivo de preocupación, Se informa de signos y síntomas en el Referencia Posible supresión inmunitaria; efecto desconocido sobre el crecimiento o asociación con carcinogenesis , neutropenia Posible supresión inmunitaria; efecto desconocido sobre el crecimiento o asociación con carcinogenesis Posible supresión inmunitaria; efecto desconocido sobre el crecimiento o asociación con carcinogenesis Posible supresión inmunitaria; efecto desconocido sobre el crecimiento o asociación con carcinogenesis, neutropenia * El medicamento se concentra en la leche humana TABLA 2
Drogas de abuso en las se ha informado efectos adversos sobre el niño lactado *
Efecto informado o motivo de preocupación Intoxicación cocaína: irritabilidad, vómitos, diarrea, Temblores, inquietud, vómitos, alimentación pobre Solo 1 informe en la literatura, no efectos mencionados; larga 35vida media para algunos componentes • El Comité de Medicamentos cree fuertemente que las madres no deben ingerir drogas de abuso, porque ellos son peligrosas para la el niño y la salud de la madre • †La Drogas se concentran en la leche humana • TABLA 3
Componentes Radioactivos que requieren cese temporal de la Lactancia * Radiactividad en leche presente durante 2 Muy pequeña cantidad presente por 20 horas 39 Radiactividad en leche presente hasta 36 Si es usado para tratamiento de Cáncer de tiroides, la alta radiactividad puedeprolongar la exposición en el niño Radiactividad en leche presente 15 h a 3 d *Consultar con medico de medicina nuclear antes de realizar un estudio diagnostico para que seutilice el radionucleido que tenga más corta excreción por la leche humana. Antes del estudio lamadre debe extraerse mediante bomba en su pecho y almacenar la suficiente leche en elfrigorífico para alimentar al niño, después del estudio la madre debe extraerse su leche paramantener la producción de la misma, pero debe descartarse para su uso toda la leche obtenidadurante el tiempo que permanezca la radiactividad en la misma. Las muestras de leche puedenser analizadas por departamentos de radiología antes de la reanudación de la lactancia.
TABLA 4
Medicamentos que el efecto sobre el niño lactado es desconocido pero puede ser de
preocupación *
Cólico, irritabilidad, desordenes sueño y alimentación, Galactorrea en madre; somnolencia y letargia en niño; Posible supresión idiosincrasia de medula ósea Potencial por trasferirse en alto porcentaje de la dosis maternal, posible incremento de la pigmentación de lapiel Potencial concentraciones terapéuticas sericas en niños Ninguno descrito; agentes bloqueantes dopaminergico Efecto mutágeno In Vitro; puede suspenderse la lactancia 113, 114por 14-24 horas para permitir la excreción de la dosis,cuando a la madre se le administra una única dosis • Los medicamentos Psicotropicos, los compuestos listados bajo la categoría de ansiolíticos, antidepresivos y antipsicoticos son de especial preocupación cuando se dan a madres quelactan por largos periodos. Aunque hay muy pocos casos que informen de efectos adversosen niños con lactancia materna estos medicamentos aparecen en la leche humana y de estamanera pueden alterar a corto y largo plazo la función del Sistema Nervioso central.56 Verdiscusión en el texto de drogas psicotropicas.
† El medicamento se concentra en la leche humana en concentraciones próximas a lasconcentraciones plasmáticas simultaneas de la madre.
TABLA 5
Medicamentos que han estado asociados con efectos significativos sobre algunos niñoslactados y debe ser dados con preocupación a las madres que lactan* Suprime la lactancia; puede ser peligroso para Somnolencia, irritabilidad, rechazo a la alimentación, grito agudo, rigidez del cuello (1caso) Vómitos, diarrea, convulsiones (dosis usadas en 131medicación de la migraña) 1/ 3 a 1/2 de la concentración terapéutica protombina y tromboplastina en 1 niño: no seusa en Estados Unidos Sedación; espasmos infantiles después del destete de leche conteniendo fenobarbital,metahemoglobinemia ( 1 CASO) * La concentración en sangre puede ser de importancia clínica.
TABLA 6
Medicación Maternal usualmente compatible con la lactancia*
Signos informados o síntomas en el niño diaforesis sueño profundo, debilidad,disminución de velocidad de crecimiento,anormal ganancia de peso, la ingestiónmaternal de 1 g/kg diariamentedisminuye el reflejo de eyección de leche Irritabilidad, patrones pobres de sueño, excretada lentamente, no efecto coningesta moderada de bebidas de café (2-3tazas por día) disminución en la producción de leche ycontenido proteico ( no confirmado envarios estudios) sericos de calcio si la madre recibe dosisfarmacológicas Isoefedrinapheniramine maleato con d- madre que lacta; los niños no deben serlactados por 48 horas materna , olor de yodo en la piel del niño Ninguno; su metabolito acetilo sé excreta 214, 261pero no se informa de hepatotoxicidad enlactantes glucosa-6-fosfato deshidrogenasa (G-6-PD) Precaución en lactantes con Ictericia o deficit G-6 Fosfato deshidrogenasa conictericia o deficit G-6-PD y enfermos ,estresados o lactantes prematuros apareceen la leche materna deficit G-6 Fosfato deshidrogenasa conictericia o déficit G-6-PD y enfermos ,estresados o lactantes prematuros apareceen la leche materna Ninguno; absorción insignificante por el * Los medicamentos de la lista que se ha informado con efectos en la literatura o no efecto. Lapalabra “ ninguno” significa que no se observan cambios en niño lactado mientras la madretoma el medicamento. La línea indica que no se menciona efecto clínico sobre el lactante. Sedebe resaltar que mucha de las citas se refiere a un único caso o una pequeña serie de lactantes.
† Medicamento se concentra en la leche humana.
TABLE 7
Alimentos y Agentes ambientales : Efectos sobre la lactancia materna
Irritabilidad o incremento de la motilidad intestinal si se excede la cantidad de ( >16oz/d) consumida por la madre Hemólisis en pacientes con déficit G-6-PD 371 Rash cutáneo , diarrea, vómitos, orina Ninguna; posible contaminación de la leche 376del lavado del pezón Falta de resistencia, hipotonía, malhumor, The recommendations in this statement do not indicate an exclusive course of treatment or serveas a standard of medical care. Variations, taking into account individual circumstances, may beappropriate.
Copyright 2001 by the American Academy of Pediatrics. No part of this statement may bereproduced in any form or by any means without prior written permission from the AmericanAcademy of Pediatrics except for one copy for personal use.
Esta traducción ha sido realizada por Juan Ruiz-Canela , revisada por Juan Aº Guerra ( Medicode Familia ) y Teresa Rodríguez (Farmacéutica) con un objetivo docente y divulgativo. Serecomienda a los clínicos verificarla con la traducción original en caso de duda.
En Algunas ocasiones el medicamento no respeta el orden alfabético y algunos productos noestán disponibles comercialmente en España

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CURRICULUM VITAE Emmerentia Margaretha van Schalkwyk M.B.,Ch.B. (U.S.), B.Sc.Med.Sc.Hons.(Epidemiology) (U.S.), Dip. Occ. Health (U.S.) Personal details : First Language Afrikaans, Fluent in English ACADEMIC QUALIFICATIONS Matriculated, La Rochel e Girls High School, Paarl BScMedScHons(Epidemiology), University of Stel enbosch Dip. Occupational Health, University of Stel enbosc

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