WHO Drug Information Vol. 16, No. 2, 2002
(2002; 91 pages) Ver el documento en el formato PDF
Índice de contenido
Abrir esta carpeta y ver su contenidoHerbal Medicines
Abrir esta carpeta y ver su contenidoCurrent Topics
Abrir esta carpeta y ver su contenidoGood Clinical Practices
Abrir esta carpeta y ver su contenidoSafety Information
Cerrar esta carpetaRegulatory Action
Ver el documentoAlosetron hydrochloride: restricted marketing
Ver el documentoBaclofen: abrupt discontinuation dangerous
Ver el documentoIrinotecan: prescribing changes
Ver el documentoSodium oxybate/GHB approved for cataplexy
Ver el documentoRofecoxib: new indication and label changes
Abrir esta carpeta y ver su contenidoEssential Medicines
Abrir esta carpeta y ver su contenidoRecent Publications and Sources of Information
Ver el documentoProposed International Nonproprietary Names: List 87
 

Baclofen: abrupt discontinuation dangerous

United states of America - The prescribing information for baclofen injection (Lioresal® Intrath-ecal) has been updated to include a warning about rare cases of withdrawal that can lead to life threatening sequelae and/or death in patients who abruptly discontinue therapy.

Baclofen injection is indicated for use in the management of severe spasticity of cerebral and spinal origin. A warning has been added to the prescribing information as follows.

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomy-olysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to proper programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).

In the first 9 years of post-marketing experience, 27 cases of withdrawal temporally related to the cessation of baclofen therapy were reported; six patients died.

Reference: Novartis Pharmaceuticals Corporation letter posted on the FDA’s MedWatch program at http://www.fda.gov/medwatch

Ir a la sección anterior
Ir a la siguiente sección
 
 
El Portal de Información - Medicamentos Esenciales y Productos de Salud de la OMS fue diseñado y es mantenido por la ONG Human Info. Última actualización: le 29 octubre 2018