Sex- and age-dependency of haematological adverse reactions associated with psychotropic drugs: Analysis of the data bank of the drug safety program for psychiatric disorders AGATE

Abstract

Introduction: Blood dyscrasias are rare psychotropic drug-related adverse reactions (ADR) and are usually only identified by spontaneous and unsystematic ADR reporting systems. The aim of this study was to further determine the importance of the patients' sex and age for the risk of psychotropic drug-related agranulocytosis, neutropenia, leukopenia, and thrombocytopenia. Methods: Currently, 45 psychiatric institutions are participating in the drug safety program AGATE (Arbeitsgemeinschaft Arzneimittelsicherheit bei psychiatrischen Erkrankungen), which systematically surveys and assesses psychotropic drug-related adverse events. For each drug, sex- and age-dependent risk factors were calculated using the drug prescription numbers which were recorded for every patient on all participating wards on two reference days per year as denominators. Results: The relative risk for women compared to men to suffer from psychotropic drug-induced blood dyscrasias was almost twice as high (120 women, 61 men). Compared to younger patients women over 60 years had a slightly higher risk (+21%). In addition, women were three times more likely to suffer from severe clinical symptoms such as pneumonia, sepsis or high fever as men. Furthermore, women had a ten times higher risk for carbamazepine-related blood dyscrasias. Conclusions: Female sex and age over 60 years additively increase the risk for occurence and clinical severity of psychotropic drug-induced haematological disorders.