Adverse events beyond the ‘usual suspects’

Abstract

Since the introduction of antipsychotic drugs into schizophrenia treatment patients complained feeling ‘fuzzy or dull’, of being ‘unable to think straight’, feeling ‘like a zombie’. All these feelings were labeled as a syndrome of ‘neuroleptic dysphoria’. Patients may even fail to distinguish adverse events from symptoms of illness; they simply classify drugs as ‘good’ or ‘bad’, or alternatively they believe that medication makes their condition worse. Negative impact of side-effects on quality of life was repeatedly confirmed in various studies. The subjective acceptance of medication is becoming increasingly important outcome measure of tolerability in trials of new drugs, naturalistic observational studies and switch studies. Similarly to the quality of life assessment, impact of drugs on patients' well-being, subjective response to treatment, attitude towards medication, or preference of medication can be measured. Variety of side-effects is associated with antipsychotic treatment. Traditionally, most of the attention is being paid to EPS, akathisia, tardive dyskinesia, and lately weight gain, metabolic, endocrinological, or ECG abnormities. However, beyond the usual list, largely overlooked adverse events, such as sedation and somnolence, orthostatic hypotension, sexual side-effects may have more severe and direct impact on patient's well-being. The outcome of illness, including treatment compliance, can be negatively affected by the group of clinically highly relevant but mostly ignored side-effects, including sexual dysfunction. Their incidence in clinical trials and everyday practice, together with their consequences, thus deserve closer scrutiny.