Safety of psychotropic drug prescribed for attention-deficit/hyperactivity disorder in Italy

Abstract

The drugs prescribed to treat attention-deficit/hyperactivity disorder, one of the most prevalent psychiatric disease affecting children and adolescents, may risk causing harm. Recently, the U.S. Food and Drug Administration (FDA) has warned about liver and cardiovascular risks, and the European Medicines Agency (EMEA) had performed an assessment of risk–benefit ratio of psychostimulants. Pharmacovigilance in an Italian population aged 6–17 years suggests that atomoxetine is more likely to be reported as causing harm than methylphenidate.