Sodium oxybate post-marketing surveillance

Journal of Clinical Sleep Medicine

Volumn 7, Issue 4, 2011, Pages 417-

  Feldman, Neil T ^a  

^a Clinical Research Group of St Petersburg   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

OXYBATE SODIUM;

DRUG FATALITY; DRUG SAFETY; HUMAN; LETTER; OBESITY; POSTMARKETING SURVEILLANCE; PRESCRIPTION;

CAUSE OF DEATH; COHORT STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG TOXICITY; FEMALE; HUMANS; MALE; PRODUCT SURVEILLANCE, POSTMARKETING; RETROSPECTIVE STUDIES; SENSITIVITY AND SPECIFICITY; SLEEP DISORDERS; SODIUM OXYBATE; SURVIVAL ANALYSIS; UNITED STATES;

EID: 80051906951     PISSN: 15509389     EISSN: 15509397     Source Type: Journal    
DOI: 10.5664/JCSM.1216     Document Type: Letter

References (6)

1. Wang Y.G., Swick T.J., Carter L.P., et al. Safety overview of postmarketing and clinical experience of sodium oxybate (Xyrem): Abuse, misuse, dependence, and diversion. J Clin Sleep Med 2009;5:365-371
2. United States Securities and Exchange Commission. Form 10-Q, Jazz Pharmaceuticals, Inc., March 31, 2011. Available: http:// www.faqs.org/sec- filings/110509/JAZZ-PHARMACEUTICALSINC- 10-Q/
3. Feldman N.T. Clinical perspective: Monitoring sodium oxybatetreated narcolepsy patients for the development of sleep-disordered breathing. Sleep Breath 2010;14:77-79
4. Figueiras A., Tato F., Fontaiñas J., Gestal-Otero J.J. Infl uence of physicians'attitudes on reporting adverse drug events: A case-control study. Med Care 1999;37:809-814
5. Bäckström M., Mjörndal T., Dahlqvist R. Under-reporting of serious adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf 2004;13:483-487 (Pubitemid 38996859)
6. Harper M.L., Helmreich R.L. Identifying Barriers to the Success of a Reporting System. In: Henriksen K, Battles JB, Marks ES, Lewin DI, eds. Advances in Patient Safety: From Research to Implementation. Rockville, MD: Agency for Healthcare Research and Quality; 2005.