Citation

Bygdell M, Brunlöf G, Wallerstedt SM, Kindblom JM. Pharmacoepidemiol. Drug Saf. 2012; 21(1): 79-86.

Affiliation

Clinical Pharmacology, Institute of Medicine, the Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.

Copyright

(Copyright © 2012, John Wiley and Sons)

DOI

10.1002/pds.2265

PMID

22076661

Abstract

PURPOSE: Psychiatric Adverse Drug Reactions (ADRs) are frequent in the pediatric population. The aim of the present study was to analyze spontaneously reported psychiatric ADRs in children during a 10-year period. METHODS: All spontaneously reported Individual Case Safety Reports (ICSRs) concerning children (<18 years old) and psychiatric adverse reactions assessed as at least possible, registered in the Swedish Drug Information System (SWEDIS) during the period 2001-2010, were extracted and characterized. Age and sex distribution and labeling/registration status were studied. RESULTS: A total of 600 ICSRs concerning 744 psychiatric adverse reactions were identified and included in the analysis. Boys were overrepresented among included ICSRs (60.3% vs. 39.7%; p < .001). After exclusion of vaccines, the three most frequently suspected drugs were montelukast, centrally working sympathomimetic drugs, and inhaled glucocorticoids. Serious adverse reactions were reported more frequently for drugs used off-label than for drugs used according to the Swedish Physician's Desk Reference. Aggressiveness was reported more frequently for boys than for girls as were suicidal conditions. CONCLUSIONS: Psychiatric ADRs in the pediatric population have been reported for a wide range of reactions and drugs and display age and sex differences including a higher number of suicidal reactions in boys. An association was seen between serious reactions and off-label drug use. Further studies are needed to elucidate safety aspects of unlicensed drugs and drugs used off-label and whether there are differences in children's susceptibility to develop ADRs. Copyright © 2011 John Wiley & Sons, Ltd.

Language: en