This database analysis suggests a low association with DRAEs for aripiprazole, haloperidol and ziprasidone, and more frequent associations with DRAEs for olanzapine, clozapine, quetiapine and risperidone. However, as spontaneous reporting of AEs cannot determine causality or definitely determine the relative risk with each agent, the results must be interpreted with caution. Nevertheless, these results are indicative of differential effects of atypical antipsychotics in their propensity to cause DRAEs, are consistent with previously published epidemiological studies and reinforce guidance on the need for metabolic monitoring in patients taking antipsychotic drugs.
Authors wish to thank Ogilvy Healthworld Medical Education for editorial assistance.Funding information
This study was supported by Bristol-Myers Squibb (Princeton, NJ, USA) and Otsuka Pharmaceutical Co., Ltd. (Tokyo, Japan). Funding was provided by Bristol-Myers Squibb.
AE = adverse event; AERS = Adverse Event Reporting System; ATC = Anatomical Therapeutic Chemical Classification System; CVD = cardiovascular disease; DRAEs = diabetes-related adverse events; EBGM = Empiric Bayes Geometric Mean; FDA = US Food and Drug Administration; MGPS = Multi-item Gamma Poisson Shrinker; MedRA = Medical Dictionary for Regulatory Activities; RR = reporting ratio.
Ross A. Baker PhD, MBA. Associate Director, Neuroscience, Bristol-Myers Squibb, 777 Scudders Mill Road, Plainsboro, NJ, 08536, USA. Tel: +1 609 897 4191; Fax: +1 609 897 6042; Email: firstname.lastname@example.org
Psychopharmacol Bull. 2009;42(1):1-21. © 2009 MedWorks Media Global
Cite this: Atypical Antipsychotic Drugs and Diabetes Mellitus in the US Food and Drug Administration Adverse Event Database: A Systematic Bayesian Signal Detection Analysis - Medscape - Jan 01, 2009.