Drug safety warnings in psychiatry: Adverse drug reactions’ signaling from 2002 to 2014

Monitoring drug-related side effects in psychiatric patients is highly recommended. In fact, frequent exposure to long-term polipharmacotherapy, poor compliance to pharmachological treatment and co-morbidity with organic illnesses requiring the prescription of other drugs are causes of pharmacokinetic/pharmacodynamic interactions. These vulnerability factors result in a certain increase in ADRs (adverse drug reactions). This study performs an analysis of the Italian medicine agency (AIFA) data, in the section “signal analysis”, to attempt an assessment of the safety warnings among the different psychotropic drug classes, belonging to the ATC class: N03 (anti-epileptics), N05 (anti-psychotics), N06 (psycho-analectic drugs). Then we analyzed, in a descriptive way, the different association between the drug and the related ADR, evaluating the different safety profiles, in relation to experimental studies, supporting the importance of the signal. In the last years, among the new 25 ADRs, 10 were related to antidepressant drugs (8 SSRI, 1 mirtazapine, 1 agomelatine). In relation to anti-psychotic drugs, 6 new correlations were found between drug and ADR onset, mainly among atypical anti-spychotics. Other correlations (6 above all) were found among anti-epileptic drugs. Among benzodiazepines, a signal linked to rabdomylysis onset was found. It is also recommended an evaluation of safety profile in relation to zolpidem prescription. The results of our systematic review are a motivational input, considering the continuous increase of safety warnings, to attentively monitor drug's prescription. Spontaneous ADRs’ signaling is a classical system to provide the required attention in relation to a potential risk.