WHO Drug Information Vol. 16, No. 2, 2002
(2002; 91 pages) Voir le document au format PDF
Table des matières
Ouvrir ce répertoire et afficher son contenuHerbal Medicines
Ouvrir ce répertoire et afficher son contenuCurrent Topics
Ouvrir ce répertoire et afficher son contenuGood Clinical Practices
Ouvrir ce répertoire et afficher son contenuSafety Information
Fermer ce répertoireRegulatory Action
Afficher le documentAlosetron hydrochloride: restricted marketing
Afficher le documentBaclofen: abrupt discontinuation dangerous
Afficher le documentIrinotecan: prescribing changes
Afficher le documentSodium oxybate/GHB approved for cataplexy
Afficher le documentRofecoxib: new indication and label changes
Ouvrir ce répertoire et afficher son contenuEssential Medicines
Ouvrir ce répertoire et afficher son contenuRecent Publications and Sources of Information
Afficher le documentProposed 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

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