WHO Drug Information Vol. 16, No. 2, 2002
(2002; 91 pages) View the PDF document
Table of Contents
Open this folder and view contentsHerbal Medicines
Open this folder and view contentsCurrent Topics
Open this folder and view contentsGood Clinical Practices
Open this folder and view contentsSafety Information
Close this folderRegulatory Action
View the documentAlosetron hydrochloride: restricted marketing
View the documentBaclofen: abrupt discontinuation dangerous
View the documentIrinotecan: prescribing changes
View the documentSodium oxybate/GHB approved for cataplexy
View the documentRofecoxib: new indication and label changes
Open this folder and view contentsEssential Medicines
Open this folder and view contentsRecent Publications and Sources of Information
View the 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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