Abstract
BACKGROUND: As a consequence of the greater use of agents affecting the serotonergic system, a syndrome of serotonin hyperstimulation has been recognized more frequently. The serotonin syndrome is characterized by a constellation of symptoms that include mental status changes, agitation, myoclonus, hyperreflexia, sweating, shivering, tremor, diarrhoea, lack of coordination, and fever. Deaths have been reported. AIM: To identify cases of the serotonin syndrome among patients prescribed a new antidepressant in general practice, and to determine doctors' awareness of the syndrome. METHOD: Patients who were dispensed nefazodone in England between 1996 and 1997 were identified using dispensed prescription data. Prescribing doctors were sent questionnaires as part of a post-marketing surveillance study. Patients reported to have experienced two or more features of the serotonin syndrome were identified, and specific questionnaires were sent to their general practitioners. RESULTS: There was a 96.2% return rate of serotonin syndrome questionnaires. Nineteen cases met criteria for the syndrome (incidence = 0.4 cases per 1000 patient-months of treatment with nefazodone). Eight patients developed symptoms while taking nefazodone alone. Serotonergic symptoms were reported to a similar degree with five other antidepressants studied by the same method. In total, 85.4% of responding general practitioners were unaware of the serotonin syndrome. CONCLUSION: Improved awareness of the syndrome is needed within general practice. There is a need to distinguish the relatively minor serotonergic symptoms from those of a severe, life-threatening serotonin syndrome.
Full Text
The Full Text of this article is available as a PDF (43.5 KB).
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Donoghue J., Tylee A., Wildgust H. Cross sectional database analysis of antidepressant prescribing in general practice in the United Kingdom, 1993-5. BMJ. 1996 Oct 5;313(7061):861–862. doi: 10.1136/bmj.313.7061.861. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Mackay F. J. Post-marketing studies: the work of the Drug Safety Research Unit. Drug Saf. 1998 Nov;19(5):343–353. doi: 10.2165/00002018-199819050-00002. [DOI] [PubMed] [Google Scholar]
- Mann R. D. William Withering and Lisbon. Pharmacoepidemiol Drug Saf. 1997 Oct;6 (Suppl 3):S1–S4. doi: 10.1002/(sici)1099-1557(199710)6:3+<s1::aid-pds309>3.3.co;2-1. [DOI] [PubMed] [Google Scholar]
- Mann R. D., Wilton L. V., Pearce G. L., Mackay F. J., Dunn N. R. Prescription-event monitoring (PEM) in 1996-a method of non-interventional observational cohort pharmacovigilance. Pharmacoepidemiol Drug Saf. 1997 Oct;6 (Suppl 3):S5–11. doi: 10.1002/(SICI)1099-1557(199710)6:3+<S5::AID-PDS272>3.0.CO;2-F. [DOI] [PubMed] [Google Scholar]
- Rawlins M. D., Jefferys D. B. Study of United Kingdom product licence applications containing new active substances, 1987-9. BMJ. 1991 Jan 26;302(6770):223–225. doi: 10.1136/bmj.302.6770.223. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Schatzberg A. F., Haddad P., Kaplan E. M., Lejoyeux M., Rosenbaum J. F., Young A. H., Zajecka J. Serotonin reuptake inhibitor discontinuation syndrome: a hypothetical definition. Discontinuation Consensus panel. J Clin Psychiatry. 1997;58 (Suppl 7):5–10. [PubMed] [Google Scholar]
- Sporer K. A. The serotonin syndrome. Implicated drugs, pathophysiology and management. Drug Saf. 1995 Aug;13(2):94–104. doi: 10.2165/00002018-199513020-00004. [DOI] [PubMed] [Google Scholar]
- Sternbach H. The serotonin syndrome. Am J Psychiatry. 1991 Jun;148(6):705–713. doi: 10.1176/ajp.148.6.705. [DOI] [PubMed] [Google Scholar]