DanceTherParkinsonV1, Main, Exploration, bibRecord, 000274

Safety Overview of Postmarketing and Clinical Experience of Sodium Oxybate (Xyrem): Abuse, Misuse, Dependence, and Diversion

Identifieur interne : 000274 ( Main/Exploration ); précédent : 000273; suivant : 000275

Safety Overview of Postmarketing and Clinical Experience of Sodium Oxybate (Xyrem): Abuse, Misuse, Dependence, and Diversion

Auteurs : Y. Grace Wang [États-Unis] ; Todd J. Swick [États-Unis] ; Lawrence P. Carter [États-Unis] ; Michael J. Thorpy [États-Unis] ; Neal L. Benowitz [États-Unis]

Source :

Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine [ 1550-9389 ] ; 2009.

RBID : PMC:2725257

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.

Citation:

Wang YG; Swick TJ; Carter LP; Thorpy MJ; Benowitz NL. Safety overview of postmarketing and clinical experience of sodium oxybate (xyrem): abuse, misuse, dependence, and diversion. J Clin Sleep Med 2009;5(4):365-371.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2725257

PubMed: 19968016
PubMed Central: 2725257

Affiliations:

Le document en format XML

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<sec><title>Methods:</title>
<p>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.</p>
</sec>
<sec><title>Results:</title>
<p>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.</p>
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<p>Cumulative postmarketing and clinical experience indicates a very low risk of abuse/misuse of sodium oxybate.</p>
</sec>
<sec><title>Citation:</title>
<p>Wang YG; Swick TJ; Carter LP; Thorpy MJ; Benowitz NL. Safety overview of postmarketing and clinical experience of sodium oxybate (xyrem): abuse, misuse, dependence, and diversion. <italic>J Clin Sleep Med 2009</italic>
;5(4):365-371.</p>
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Danse-thérapie et Parkinson

Safety Overview of Postmarketing and Clinical Experience of Sodium Oxybate (Xyrem): Abuse, Misuse, Dependence, and Diversion

Safety Overview of Postmarketing and Clinical Experience of Sodium Oxybate (Xyrem): Abuse, Misuse, Dependence, and Diversion

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