Article
Antidepressant Drug Use and Off-label Prescribing in Children and Adolescents in Germany
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Published: | September 20, 2011 |
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Background: Intensive off-label use of antidepressant medication in pediatric patients has been reported from the US and other European countries. An increased risk of suicide has been of concern particularly for selective serotonin reuptake inhibitors (SSRI), leading to a warning of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in April 2005.
Objectives: To characterize prescribing of antidepressant drugs for children and adolescents in Germany in 2004-2006
Methods: We obtained data from the German Pharmacoepidemiological Research Database (GePaRD) for the years 2004-2006.This database includes more than 14 million insurance members from 4 German health insurances. Prevalence of antidepressant use was assessed. Off-label use of all antidepressant prescribing was considered in relation to age and indication. Logistic regression analysis was used to identify predictors of off-label use.
Results: Of 2,599,685 children, we identified 9,383 who received a total of 26,543 antidepressant drug dispensations in the study period. Prevalence of antidepressant drug use (SSRI use) was 1.84 (0.47) per 1,000 person-years in 2004, 1.57 (0.45) in 2005 and 1.66 (0.54) in 2006. Of all antidepressant dispensations, 11,172 (42.09%) were tricyclic antidepressants (TCA), 9,179 (34.58%) were SSRI, 4,371 (16.47%) were drugs of St John's wort and 1,821 (6.86%) were other antidepressants. Of all children treated with antidepressant drugs, 6,353 (67.71%) ever got an off-label prescription, 3,446 (36.73%) with respect to age and 4,378 (46.66%) with respect to indication. Male sex and specialist treatment increased the risk of getting an antidepressant prescribed off-label with odds ratios of 1.56 (95% CI 1.49 to 1.64) and 1.14 (95% CI 1.08 to 1.20), respectively.
Conclusions: Our study showed considerable off-label use of antidepressants in pediatric patients in Germany. After warning of CHMP, prevalence of SSRI use did not decrease during the study period.