Reporting on Adverse Clinical Events

Abstract

A case/noncase disproportionality analysis report using data from VigiBase (1968-2016) evaluated the cases of sialorrhea associated with the use of antipsychotics. Cases of “salivary hypersecretion” were considered cases, and those with other adverse events were defined as noncases. A total of 1 169 254 drug-adverse drug reaction pairs from 425 304 unique Individual Case Safety Reports were identified. Sialorrhea was more frequently reported with clozapine (n = 2732 [1.1%]) compared with other antipsychotics (n = 2911 [0.31%]; reporting odds ratio = 3.60; 95% confidence interval = 3.41-3.79). In addition, sialorrhea was also reported relatively more often by consumers (reporting odds ratio = 19.8; 95% confidence interval = 15.1-25.9) compared with health care professionals (reporting odds ratio = 2.44; 95% confidence interval = 2.272.63). Based on the results of this disproportionality analysis report, the authors concluded that sialorrhea was reported almost 4 times more often with clozapine use than with other antipsychotic use and was reported 8 times more often by patients than by health care professionals. Clozapine [Clozapine] Man WH et al (ER Heerdink, Division of Pharmacoepidemiology and Clinical Pharmacology, Department of Pharmaceutical Sciences, Faculty of Science, Utrecht University, PO Box 80.082, 3508 TB Utrecht, Netherlands; e-mail: E.R.Heerdink@uu.nl) Reporting patterns of sialorrhea comparing users of clozapine to users of other antipsychotics: a disproportionality analysis using VigiBase. J Clin Psychopharmacol 40:283–286 (May) 2020