title: [Drug safety warnings in psychiatry: adverse drug reactions' signaling from 2002 to 2014].
abstract: OBJECTIVE
  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 comorbidity with organic illnesses requiring the prescription of other drugs are causes of pharmacokinetic/pharmacodynamic interactions. These vulnerability factors result in a certain increase in adverse drug reactions (ADRs).
  
  
  METHODS
  This study performes an analysis of Italian Medicine Agency 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 (antiepileptics), N05 (antipsychotics), N06 (psycho-analectic drugs). Then we analysed, 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.
  
  
  RESULTS
  In the last years, among the new 25 ADRs, 10 were related to antidepressant drugs (8 SSRI, 1 mirtazapine, 1 agomelatine). In relation to antipsychotic drugs, 6 new correlations were found between drug and ADR onset, mainly among atypical antispychotics. Other correlations (6 above all) were found among antiepileptic 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.
  
  
  CONCLUSIONS
  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. The clinician in charge must report this because he is the key figure in the drugs' safety process.
  
  
  CONCLUSIONS
  In psychiatry, in which a long-term pharmachological therapy is frequent, clinicians are requested to find and signal ADRs to the competent authority.
authors.affiliation: Dipartimento di Salute Mentale e Fisica e Medicina Preventiva, Università di Napoli SUN.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Prisco
authors.affiliation: Dipartimento di Salute Mentale e Fisica e Medicina Preventiva, Università di Napoli SUN.
authors.forename: Teresa
authors.initials: T
authors.lastname: Iannaccone
authors.affiliation: Dipartimento di Salute Mentale e Fisica e Medicina Preventiva, Università di Napoli SUN.
authors.forename: Adriano
authors.initials: A
authors.lastname: Tusciano
authors.affiliation: Dipartimento di Salute Mentale e Fisica e Medicina Preventiva, Università di Napoli SUN.
authors.forename: Mariangela
authors.initials: M
authors.lastname: Boccardi
authors.affiliation: Dipartimento di Salute Mentale e Fisica e Medicina Preventiva, Università di Napoli SUN.
authors.forename: Francesco
authors.initials: F
authors.lastname: Perris
authors.affiliation: Dipartimento di Medicina Sperimentale, Università di Napoli SUN.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Capuano
authors.affiliation: Dipartimento di Salute Mentale e Fisica e Medicina Preventiva, Università di Napoli SUN.
authors.forename: Francesco
authors.initials: F
authors.lastname: Catapano
authors.affiliation: Dipartimento di Salute Mentale e Fisica e Medicina Preventiva, Università di Napoli SUN.
authors.forename: Michele
authors.initials: M
authors.lastname: Fabrazzo
mesh_terms: D000927:Anticonvulsants / Q000009:adverse effects; D000928:Antidepressive Agents / Q000009:adverse effects*; D014150:Antipsychotic Agents / Q000009:adverse effects*; D011307:Drug Prescriptions; D006801:Humans; D007558:Italy; D011570:Psychiatry
chemical_list: D000927:Anticonvulsants; D000928:Antidepressive Agents; D014150:Antipsychotic Agents