Reacciones Adversas Graves Relacionadas con la Inyección Intramuscular de Penicilina Benzatínica

Diciembre 2008

09/12/08

FARMACOVIGILANCIA

COMUNICADO A LOS PROFESIONALES DE LA SALUD

REACCIONES ADVERSAS GRAVES RELACIONADAS CON LA INYECCIÓN INTRAMUSCULAR DE PENICILINA BENZATÍNICA


La aplicación intramuscular de medicamentos es utilizada cuando la enfermedad del paciente y/o las propiedades farmacocinéticas del medicamento excluyen otras vías. La vía intramuscular tiene grandes ventajas cuando las demás vías no pueden utilizarse, como en el caso de drogas irritantes, soluciones concentradas, suspensiones oleosas, acuosas y de depósito. Pero junto con los beneficios se deben reconocer los riesgos: nervios, huesos, tejidos y vasos sanguíneos pueden ser lesionados o convertirse en la puerta de entrada de microorganismos.

Casos clínicos de pacientes con eventos graves por la administración de penicilina benzatínica reportados al Programa Nacional de Farmacovigilancia.

Caso No. 1: Paciente de 18 meses de edad afectado de angina, recibe inyección intramuscular de 1.200.000 UI de penicilina G benzatínica. Inmediatamente después de la administración del agente (10 min) se observa cianosis generalizada en todo el miembro homolateral, e impotencia funcional de los miembros superiores e inferiores. Perdió la sensibilidad, con hipotonía de ambos miembros inferiores, que impidieron la marcha normal que nunca fue recuperada. El desarrollo psicológico del niño fue normal. Luego de 9 meses de evolución conservaba una cicatriz retractila con hundimiento de masa muscular glútea, atrofia e hipotonía muscular. Actualmente es lucido, el desarrollo psíquico y la maduración son acordes con la edad, aunque los miembros inferiores permanecen hipotónicos, con atrofia muscular a predominio derecho (el sitio de la aplicación de la penicilina G benzatínica), la cicatriz glútea es retractil, rojiza y fibrosa.

Caso No. 2:
Paciente de 7 años de edad, con diagnostico de angina pultácea a repetición. Es tratado con Penicilina benzatínica 1.200.000 UI con el agregado de 2 cc de lidocaína al 2%, vía intramuscular. Cinco minutos después de la aplicación de la penicilina benzatínica aparece bruscamente un cuadro isquémico en el hemiabdomen del sitio de la aplicación, glúteo, testículo, escroto, muslo y pierna. La piel del pie del mismo lado, se presenta cianótica, pálida y sin pulso arterial. Treinta minutos después de la aplicación, el paciente desarrolla epigastralgia intensa, palidez y sudoración generalizadas. A los 3 meses de la reacción refería dolor y dificultad al caminar del lado de la aplicación. Un año después esta recuperado y sin secuelas.

Caso No. 3:
Paciente de 16 años de edad, es tratada con 2.400.000 UI de Penicilina benzatínica por una faringitis. La paciente desarrolla dolor en el sitio de la inyección, cuadrante superior externo de la región glútea, que aumenta de intensidad progresivamente y dificulta la marcha. A los 2 días presenta una induración en el glúteo del sitio de la administración, posteriormente, necrosis y un absceso purulento que termina evacuando espontáneamente. El dolor se extendió a todo el miembro inferior. Finalmente cura dejando una cicatriz retractil de 4 a 5 cm de diámetro de color negro.

Caso No. 4:
Paciente de 12 años, que recibe 50.000 UI/Kg de Penicilina G Benzatínica por un flemón paramigdalino. A los 30 minutos de la aplicación IM, presenta fenómenos vásculo motores en la región glútea, que se extiende al muslo, con pérdida de la sensibilidad de los miembros inferiores; luego presenta paraplejía. A partir de las 3 horas, recupera la sensibilidad, pero no la motricidad. Los estudios complementarios fueron negativos. El paciente padeció como secuela una marcha en Stepage.

La patología derivada de la inyección intraarterial de penicilina benzatínica son efectos adversos graves, de baja frecuencia. Lo preocupante de este hecho es que aun con una buena técnica de inyección no es posible aspirar sangre cuando la aguja se encuentra en la luz de un vaso, posiblemente debido a la producción de vasoespasmo o a la misma viscosidad del preparado. El fluido aparentemente seguiría por un camino retrogrado superando la presión de la inyección a la presión intraarterial, pudiendo llegar el fluido a la bifurcación de las iliacas. Los factores que podrían favorecer el accidente serían la escasa masa muscular por la edad del paciente (sobre todo en menores de 2 años) y/o por la desnutrición. El mecanismo por el cual se desencadena la isquemia y posterior necrosis no es bien conocido, aunque existen varias teorías, como la liberación local de noradrenalina que puede producir vasoespasmo, la precipitación del medicamento en pequeñas arteriolas y oclusión mecánica de las mismas o lesión irritativa directa del medicamento.

Como la prevención de estos accidentes es muy difícil, dado que se han producido casos de inyección intraarterial aún con buena técnica de administración, la prevención debe basarse en una correcta indicación para limitar el número de pacientes de riesgo:

    * Infecciones leves a moderadas de las vías respiratorias superiores por Streptococos Grupo A (especialmente en áreas endémicas de Fiebre reumática, especialmente cuando se duda de la adherencia del paciente a cualquier esquema oral)
    * Infecciones venéreas: sífilis, frambesia, bejel y pinta (siempre y cuando no haya evidencia de neurolúes)
    * Tratamiento preventivo de fiebre reumática y/o corea
    * Tratamiento preventivo de reumatismo cardíaco
    * Tratamiento preventivo de glomerulonefritis (Especialmente cuando la adherencia del paciente a otro régimen antimicrobino es cuestionable)

Muchas veces estos accidentes son impredecibles, ya que pueden producirse aun con una buena técnica de administración, por lo que la prevención de los mismos se debe basar en el Uso Racional del Medicamento, es decir evitar su utilización en menores de 2 años y en desnutridos, realizar una correcta indicación, evitando exponer a los pacientes a riesgos innecesarios.

Reacciones adversas informadas al Sistema Nacional de Farmacovigilancia, desde el año 2005 relacionadas con la aplicación de Penicilina Benzatínica: reacción alérgica, erupción cutánea, prurito, exantema generalizado, rash, edema de glotis, shock anafiláctico, nauseas, temblor, dolor en sitio de inyección, incontinencia fecal, incontinencia urinaria.


Bibliografía:


-Alerta por reacciones no alergicas graves a penicilina benzatinica en el nordeste argentino
Valsecia; Malgor; Ramonda; Zubryzcki; Godoy
-Efectos adversos graves por inyección intramuscular de penicilina benzatínica
Bologna, Foppiano, Godoy., Lombardo, Malgor, Ramonda, Valsecia, Zubrizcki
-Informe Farmacovigilancia ANMAT 2008
-Martindale 2008
-Micromedex 2008


Fuente: Ministerio de Salud. Dirección Provincial de Bioquímica, Farmacia y Droguería Central. Programa Provincial de Farmacovigilancia. Boletín Informativo: Nº 24/08.

Este y otros artículos relacionados con FARMACOVIGILANCIA se encuentran disponibles en www.colfarsfe.org.ar

Se recuerda la importancia de notificar todas las sospechas de reacciones adversas mediante la hoja amarilla a: cfstafe@satlink.com Puede solicitarla en el DAP o bajarla de la página web del Colegio www.colfarsfe.org.ar




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