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

Y. Grace Wang, Todd J. Swick, Lawrence P. Carter, Michael J. Thorpy, Neal L. Benowitz

Research output: Contribution to journalArticle

60 Citations (Scopus)

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 ≥ 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.

Original languageEnglish (US)
Pages (from-to)365-371
Number of pages7
JournalJournal of Clinical Sleep Medicine
Volume5
Issue number4
StatePublished - Aug 15 2009

Fingerprint

Sodium Oxybate
Safety
Diagnostic and Statistical Manual of Mental Disorders
Substance-Related Disorders
Cataplexy
Narcolepsy
Substance Withdrawal Syndrome
Traffic Accidents
Terminology
Causality

Keywords

  • Abuse
  • Death
  • Dependence
  • Diversion
  • Overdose
  • Sexual assault
  • Sodium oxybate
  • Suicide
  • Traffic accident
  • Xyrem

ASJC Scopus subject areas

  • Clinical Neurology
  • Pulmonary and Respiratory Medicine
  • Neurology

Cite this

Safety overview of postmarketing and clinical experience of sodium oxybate (Xyrem) : Abuse, misuse, dependence, and diversion. / Wang, Y. Grace; Swick, Todd J.; Carter, Lawrence P.; Thorpy, Michael J.; Benowitz, Neal L.

In: Journal of Clinical Sleep Medicine, Vol. 5, No. 4, 15.08.2009, p. 365-371.

Research output: Contribution to journalArticle

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abstract = "Study Objectives: This study reviewed the cumulative postmarketing and clinical safety experience with sodium oxybate (Xyrem{\circledR}), 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 ≥ 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.",
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