Safety Concerns

Abstract

A crucial feature of any drug development process is an appraisal of the safety of the drug in humans. The safety of CNS drugs is of particular relevance when we consider the characteristics of the population that will receive them; some of these features are summarised in Table 7.1. The psychopathology of psychiatric conditions means that many patients are at a high risk of taking their own life, and could use their prescribed drugs as a means to commit suicide. In addition, as psychiatric diseases are often diagnosed at an early age, there is the need for pharmacotherapy at the earlier stages of the lifespan, e.g. in children and adolescents. Moreover, older patients will also be likely to receive antidepressants, sedative/hypnotics and antipsychotics, in addition to treatments for the older-onset illnesses such as Alzheimer's and Parkinson's diseases. As psychiatric disease has a high prevalence in young women of child-bearing age, the effects of drug treatment on the developing foetus and the neonate is another important consideration. Most CNS disorders should be viewed as potentially life-long conditions, which as a consequence will require pharmacotherapy for a significant period of the patient's lifespan. The consequences are the potential development of toxicities over a long-term period, which might not be evident following the shorter treatment timeframe that is often employed in premarketing clinical trials. Concomitant administration of drugs to treat comorbid conditions is also extremely common, particularly amongst the older patient populations. These issues will form the basis of this chapter.