Adverse events in 583 valproate-treated patients

Abstract

Double-blind placebo-controlled studies indicate that valproate is an effective therapy for bipolar mania. The objective of this research was to evaluate the profile of adverse events associated with the medical management of bipolar disorder when valproate was administered with routine adjunctive psychotropic agents. A structured retrospective chart review for adverse events was done in 583 valproate-treated bipolar patients across five medical centers. Valproate was used for 3 months by 392 patients and >1 year in 168. For 961 patient-years, 97% patients were treated concomitantly with other medications. Eighty-three percent of patients were comorbid, with clinically significant medical illnesses. The average total daily dose of valproate was approximately 1400 mg and serum level was 82 μg/ml. Consistent with prior reports in epilepsy, adverse events associated with valproate included (in order of decreasing prevalence) tremor, nausea, somnolence, hair changes/thinning, asthenia, diarrhea, weight gain, dizziness, abdominal pain/stomach cramping, benign thrombocytopenia, headaches, and vomiting. These data suggest that when valproate is openly administered with a wide array of other psychiatric medications over relatively long periods, as is frequently the case in routine clinical practice, the profile of valproate-related adverse events is similar to those already observed in the treatment of epilepsy. Depression 3:257–262 (1995/1996). © 1996 Wiley-Liss, Inc.