La FDA advierte sobre los peligros de las inyecciones epidurales de esteroides para el dolor de espalda

La Administración de Drogas y Alimentos (FDA, por sus siglas en inglés) acaba de emitir lo que se llama una alerta de “Medwatch Alert” de que las inyecciones epidurales de esteroides o “ESI” para el dolor de espalda y cuello pueden ser extremadamente peligrosas. La alerta dice: “La inyección de corticosteroides en el espacio epidural de la columna vertebral puede ocasionar eventos adversos raros pero graves, que incluyen pérdida de visión, accidente cerebrovascular, parálisis y muerte”.

Las inyecciones epidurales de esteroides, y las lesiones catastróficas causadas por ellas, fueron el tema de mi investigación de debut para  The Dr. Oz Show hace  casi exactamente un año. (Puede ver el video aquí y leer el artículo web aquí). El espacio epidural es un área entre la médula espinal y la estructura ósea de la columna vertebral.

Nuestra investigación reveló que los esteroides, llamados corticosteroides, utilizados para inyecciones epidurales ni siquiera están aprobados por la FDA para este propósito y, sin embargo, los ESI se realizan casi 9 millones de veces al año, según un análisis realizado por el Dr. Laxmaiah Manchikanti.

Además de informar al público a través de Medwatch Alert, la FDA dijo: “Estamos requiriendo la adición de una  Advertencia  a las etiquetas de medicamentos de corticosteroides inyectables para describir estos riesgos”. Los corticosteroides inyectables incluyen metilprednisolona, ​​hidrocortisona, triamcinolona, ​​betametasona y dexametasona .

La nueva advertencia será un recordatorio más importante para los médicos de que inyectar esteroides en el espacio epidural, justo afuera de la médula espinal, tiene riesgos. Pero la advertencia no logró enumerar todas las posibles reacciones adversas. Esas reacciones se mencionan en la letra pequeña de las etiquetas actuales de los medicamentos e incluyen: “aracnoiditis, disfunción intestinal / vesical, cefalea, meningitis, paraparépia / paraplejia, convulsiones, trastornos sensoriales”.

En 2009, la FDA convocó a un grupo para estudiar la seguridad de algunos tipos de inyecciones epidurales de esteroides. En su nuevo aviso, la FDA dijo que las recomendaciones del grupo aún no están listas y se publicarán cuando lo estén.

Dennis Capolongo, de EDNC, un grupo que ha estado haciendo campaña contra las inyecciones epidurales de esteroides durante años, calificó la nueva advertencia de la FDA como “amarga y dulce” porque no fue más allá. Capolongo quiere que la FDA vaya más allá de decirle a los médicos que inyectar esteroides en el espacio epidural PODRÍA tener efectos secundarios graves y, en cambio, declarar que NO DEBEN hacerlo.

En febrero de este año, las autoridades sanitarias australianas y neozelandesas publicaron exactamente ese lenguaje más fuerte, afirmando que los esteroides como este “NO DEBEN ser utilizados por las rutas intratecales, epidurales, intravenosas o de otro tipo no especificadas”. El gobierno sudafricano emitió Advertencias similares, según Capolongo.

Dado que la FDA todavía está estudiando activamente estos procedimientos, será interesante ver si la agencia toma medidas adicionales. Si y cuando lo haga, puedes apostar a que pasaré la información.

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154 thoughts on “La FDA advierte sobre los peligros de las inyecciones epidurales de esteroides para el dolor de espalda

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