Safety overview of postmarketing and clinical experience of sodium oxybate (Xyrem): abuse, misuse, dependence, and diversion.

Abstract

STUDY OBJECTIVES:

This study reviewed the cumulative postmarketing and clinical safety experience with sodium oxybate (Xyrem), a treatment approved for cataplexy and excessive daytime sleepiness in narcolepsy. Study objectives were to investigate the occurrence of abuse/misuse of sodium oxybate since first market introduction in 2002, classify cases using DSM-IV criteria for substance abuse and dependence, and describe specific characteristics of these cases.

METHODS:

We retrospectively reviewed postmarketing spontaneous adverse event (AE) reports from 15 countries for all cases containing reporting terminology related to abuse/misuse to determine its occurrence. All death cases independent of causality were reviewed to identify associated risk factors.

RESULTS:

Approximately 26,000 patients worldwide received sodium oxybate from first market introduction in 2002 through March 2008. Of those 26,000 patients, 0.2% reported > or = 1 of the events studied. These included 10 cases (0.039%) meeting DSM-IV abuse criteria, 4 cases (0.016%) meeting DSM-IV dependence criteria, 8 cases (0.031%, including 3 of the previous 4) with withdrawal symptoms reported after discontinuation of sodium oxybate, 2 confirmed cases (0.008%) of sodium oxybate-facilitated sexual assault, 8 cases (0.031%) of overdose with suicidal intent, 21 deaths (0.08%) in patients receiving sodium oxybate treatment with 1 death known to be related to sodium oxybate, and 3 cases (0.01%) of traffic accidents involving drivers taking sodium oxybate. During this period, approximately 600,000 bottles of sodium oxybate were distributed, and 5 incidents (0.0009%) of diversion were reported.

CONCLUSION:

Cumulative postmarketing and clinical experience indicates a very low risk of abuse/misuse of sodium oxybate.

• Authors: Y Grace Wang, Todd J Swick, Lawrence P Carter, Michael J Thorpy, Neal L Benowitz
• Journal: Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine (J Clin Sleep Med) Vol. 5 Issue 4 Pg. 365-71 (Aug 15 2009) ISSN: 1550-9389 [Print] United States
• PMID: 19968016 (Publication Type: Journal Article, Review)

Chemical References

• Central Nervous System Depressants
• Sodium Oxybate

Topics

• Accidents, Traffic (statistics & numerical data)
• Central Nervous System Depressants (adverse effects)
• Disorders of Excessive Somnolence (drug therapy)
• Drug Overdose (epidemiology)
• Drug Utilization
• Drug-Related Side Effects and Adverse Reactions
• Humans
• Product Surveillance, Postmarketing
• Rape (statistics & numerical data)
• Risk
• Sodium Oxybate (adverse effects)
• Substance-Related Disorders (epidemiology)