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

Sodium oxybate/GHB approved for cataplexy

United States of America - The Food and Drug Administration has approved sodium oxybate or gamma hydroxybutyrate (also known as GHB) (Xyrem ®) for treatment of patients with narcolepsy who experience episodes of cataplexy, a condition characterized by weak or paralysed muscles. Because of safety concerns associated with the use of the drug, distribution will be highly restricted.

In the early 1990s, GHB was marketed as a dietary supplement with claims for enhancing athletic performance, sexual activity and for inducing sleep. It was also abused as a recreational drug and is well-known for use in date rape. As a result of a number of serious adverse events, including death, FDA intervened to prohibit marketing of GHB.

Sodium oxybate has been designated as a Schedule III Controlled Substance for medical use, meaning it cannot be sold, distributed, or provided to anyone other than for its prescribed use. Illicit use will be subject to penalties under Schedule I, the most restrictive schedule of the Controlled Substances Act.

Narcolepsy affects about 120 000 people in the United States. This rare condition causes an irresistible tendency to fall asleep even in unlikely circumstances such as in the middle of a conversation or at a meal. Cataplexy, a symptom of this condition, is a sudden loss of muscular control and weakness usually triggered by emotions such as amusement, anger or excitement, and is estimated to affect about 20 000 to 50 000 individuals. The effects of cataplexy range from dropping of the jaw and slumping of the head, to buckling of the legs and even collapse of the whole body. These effects can last for a few seconds or up to many minutes.

Side effects associated with sodium oxybate include confusion, depression, nausea, vomiting, dizziness, headache, bedwetting, and sleepwalking. Abuse could also lead to dependence, i.e, craving for the medicine, and severe withdrawal symptoms. A medication guide further advises patients about proper use, administration and disposal of the drug.

Reference: http://www.fda.gov/medwatch

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Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 29 octobre 2018