BENZOCAÍNA TÓPICA (spray  – gel  – solución)  – Anestésico tópico  –
Riesgo de Metahemoglobinemia.
(FDA – EEUU,  07/04/2011)
La benzocaína, principalmente en spray, geles y líquidos, se utiliza
habitualmente para aliviar el dolor de una variedad de condiciones tales como úlceras bucales e irritación de la boca y las encías.4/13
Recientemente, la FDA y diversas agencias internacionales advirtieron a los profesionales y al público  en  general que el uso de benzocaína se asocia con una enfermedad rara pero grave, llamada metahemoglobinemia, en la cual la cantidad de oxígeno transportado por el torrente sanguíneo se reduce
considerablemente. En los casos más graves,  esta enfermedad  puede
ocasionar la muerte.
Por ese motivo, la agencia sanitaria norteamericana recomendó que los
productos que contienen benzocaína no deben usarse en niños menores de dos años, excepto bajo la indicación y la supervisión de un profesional de la salud.
Además, se alerta a los consumidores para que almacenen los productos con dicho principio activo fuera del alcance de los niños.
En cuanto a los pacientes adultos, la FDA los instó a que consulten con los profesionales de la salud sobre el uso de benzocaína y a que sigan las
recomendaciones del prospecto del producto.
Ir a Web
En nuestro país se comercializan  los siguientes productos con
benzocaína en formas farmacéuticas tópicas: Muelita Gel Adultos
(Cabuchi)  benzocaína al 10%, Muelita Gel Pediátrico (Cabuchi)
benzocaína 2%, Muelita Kit (Cabuchi) 2% y Odontogel (E. J. Gezzi)
Es importante recalcar que las concentraciones son mucho menores a
las que causaron los casos descriptos en EEUU.

English

Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia

AUDIENCE: Family Practice, Pharmacy, Consumers

ISSUE: FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

BACKGROUND: Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.

RECOMMENDATIONS:

Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label.
Consumers should store benzocaine products out of reach of children.
FDA encourages consumers to talk to their healthcare professional about using benzocaine.
Read the two Drug Safety Communications below for other specific recommendations for Healthcare Professionals, for Consumers and Caregivers and the Data Summary which supports these recommendations.
FDA is continuing to evaluate the safety of benzocaine products and the Agency will update the public when it has additional information.
FDA will take appropriate regulatory actions as warranted.

Fuente:  FDA  y  ANMAT

 

 

 

 

 

Para más información puede acceder a los sitios oficiales del ANMAT | FDA

 

 

 
 

 

 

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