TY - JOUR
T1 - Are non-serious adverse reactions to psychiatric drugs really non-serious?
AU - Pozzi, Marco
AU - Bertella, Silvana
AU - Cattaneo, Dario
AU - Molteni, Massimo
AU - Perrone, Valentina
AU - Carnovale, Carla
AU - Antoniazzi, Stefania
AU - Clementi, Emilio
AU - Radice, Sonia
PY - 2013/8/1
Y1 - 2013/8/1
N2 - Objective: The EudraVigilance Pharmacovigilance system classifies the seriousness of adverse drug reactions (ADRs) based on the requirement of hospital care. To date, no systematic study has been conducted on the impact of non-serious ADRs, in terms of therapy continuation and course of the underlying disease. We analyzed a pediatric population receiving psychiatric care and subjected to drug treatment, to assess whether non-serious ADRs do or do not have a relevant clinical impact. Methods: Data from a 1 year period were collected, which included: Administered drugs, choices made to manage the ADRs, the long-term (6 month) effect of these interventions on the course of the reaction, and their impact on the drug treatment for the underlying pathology. Results: Observed ADRs were concordant with those previously described for the same drug classes, and mainly comprised alterations of behavior, mood, and sleep (53%) and excessive variations of appetite and body weight (39%). The type of drug influenced the management decision, as we found that drug discontinuation was the most frequent strategy employed to resolve ADRs, especially with drugs employed in the treatment of attention-deficit/hyperactivity disorders (63%, p
AB - Objective: The EudraVigilance Pharmacovigilance system classifies the seriousness of adverse drug reactions (ADRs) based on the requirement of hospital care. To date, no systematic study has been conducted on the impact of non-serious ADRs, in terms of therapy continuation and course of the underlying disease. We analyzed a pediatric population receiving psychiatric care and subjected to drug treatment, to assess whether non-serious ADRs do or do not have a relevant clinical impact. Methods: Data from a 1 year period were collected, which included: Administered drugs, choices made to manage the ADRs, the long-term (6 month) effect of these interventions on the course of the reaction, and their impact on the drug treatment for the underlying pathology. Results: Observed ADRs were concordant with those previously described for the same drug classes, and mainly comprised alterations of behavior, mood, and sleep (53%) and excessive variations of appetite and body weight (39%). The type of drug influenced the management decision, as we found that drug discontinuation was the most frequent strategy employed to resolve ADRs, especially with drugs employed in the treatment of attention-deficit/hyperactivity disorders (63%, p
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U2 - 10.1089/cap.2012.0094
DO - 10.1089/cap.2012.0094
M3 - Article
C2 - 23952186
AN - SCOPUS:84882787944
VL - 23
SP - 394
EP - 400
JO - Journal of Child and Adolescent Psychopharmacology
JF - Journal of Child and Adolescent Psychopharmacology
SN - 1044-5463
IS - 6
ER -