Effect of regulatory warnings on antidepressant prescription rates, use of health services and outcomes among children, adolescents and young adults
Open Access
- 8 April 2008
- journal article
- Published by CMA Impact Inc. in CMAJ : Canadian Medical Association Journal
- Vol. 178 (8) , 1005-1011
- https://doi.org/10.1503/cmaj.071265
Abstract
Background: Regulatory bodies worldwide, including Health Canada, have issued warnings about prescribing antidepressants to children and adolescents. We sought to determine whether the Health Canada warning had the desired effects on prescribing patterns and outcomes and whether it had any unintended health consequences. Methods: We examined data from prescription and health care databases representing more than 265 000 children, adolescents and young adults annually to determine changes in the rates of antidepressant prescription, use of health services and outcomes in these populations in the 9 years before and the 2 years after the Health Canada warning. We also examined the data for unintended changes in these rates among patients with anxiety disorders. We used young adults as the comparison group because they were not targeted by the warning. Results: Following the warning, the rate of antidepressant prescriptions decreased among children and adolescents (relative risk [RR] 0.86, 95% confidence interval [CI] 0.81–0.91) and among young adults (RR 0.90, 95% CI 0.86–0.93). Ambulatory visits because of depression decreased among children and adolescents (RR 0.90, 95% CI 0.85–0.96) and young adults (RR 0.91, 95% CI 0.87–0.96). The rate of completed suicides among children and adolescents rose significantly after the warning (RR 1.25, 95% CI 1.08–1.44; annual rate per 1000 = 0.04 before and 0.15 after the warning). There was no equivalent change in the rate of completed suicides among young adults (RR 1.01, 95% CI 0.93–1.10; annual rate per 1000 = 0.15 before and 0.22 after the warning). Among patients with an anxiety disorder, the prescription rates did not change among children and adolescents, except for a decrease in the use of selective serotonin reuptake inhibitors other than fluoxetine, but the rates among young adults changed similar to the pattern of changes in the overall prescribing of antidepressants. There was also a significant decrease in the rate of physician visits because of anxiety disorders among young adults after the warning. Interpretation: Health advisories and warnings issued by regulatory bodies may have unintended consequences on the provision of care, delivery of health services and clinical outcomes. Further efforts are required to ensure that health warnings do not result in unexpected harm.Keywords
This publication has 25 references indexed in Scilit:
- Effects of Food and Drug Administration Warnings on Antidepressant Use in a National SampleArchives of General Psychiatry, 2008
- The Revised Warning for Antidepressants and Suicidality: Unveiling the Black Box of Statistical AnalysesAmerican Journal of Psychiatry, 2007
- What happened to the prescribing of other COX‐2 inhibitors, paracetamol and non‐steroidal anti‐inflammatory drugs when rofecoxib was withdrawn in Australia?Pharmacoepidemiology and Drug Safety, 2007
- Early Evidence on the Effects of Regulators’ Suicidality Warnings on SSRI Prescriptions and Suicide in Children and AdolescentsAmerican Journal of Psychiatry, 2007
- Spillover Effects on Treatment of Adult Depression in Primary Care After FDA Advisory on Risk of Pediatric Suicidality With SSRIsAmerican Journal of Psychiatry, 2007
- Pediatric Primary Care Providers and Adolescent Depression: A Qualitative Study of Barriers to Treatment and the Effect of the Black Box WarningJournal of Adolescent Health, 2007
- The Effect of Antidepressant Warnings on Prescribing Trends in Ontario, CanadaAmerican Journal of Public Health, 2007
- The effect of the withdrawal of rofecoxib on prescribing patterns of COX-2 inhibitors in ScotlandBritish Journal of Clinical Pharmacology, 2006
- Effects of the Committee on Safety of Medicines Advice on Antidepressant Prescribing to Children and Adolescents in the UKDrug Safety, 2005
- Decrease in antibiotic use among children in the 1990s: not all antibiotics, not all childrenCMAJ : Canadian Medical Association Journal, 2004