In the wake of a U.S. Food and Drug Administration (FDA) Advisory in 2003 about the increased risk of suicidality for children taking antidepressant medications, diagnosis and treatment of depression in both children and adults has significantly declined from expected rates.
The new research examined the PHARMetrics health care claims database from 1999 to 2007 of 643,313 patients and 792,807 episodes of possible diagnosis and treatment for depression. The researchers examined rates of depression diagnoses, antidepressant use for depression, use of psychotherapy after diagnosis, and the use of antidepressant alternatives after diagnosis for the periods before and after the FDA advisory was issued.
After steady increases in depression diagnoses among children between 1999 and 2004, the diagnoses of depression began to decline in 2005, dropping to 3.5 per 1,000 enrollees in 2007. This rate was, according to the researchers, nearly back to 1999 levels.
The study cannot answer the question of whether the FDA warning actually caused the decline in diagnosis and treatment of depression; the researchers only observed a correlational effect as reported by claims data. However, the researchers strongly suggested that the FDA warning was the cause of this decline.
“Regulating the safety of pharmacological agents is part of the FDA’s mission,” wrote the researchers, “and the boxed warning, medication guide, and package insert are all policy tools for communicating
“All of these were used to communicate risk of suicidality in the absence of a single death in a randomized clinical trial for antidepressants; yet, the medication guide and package insert are considered the strongest form of warning short of pulling drugs off of the market.”
In addition to the decline in diagnosis and treatment of depression in children, the researchers — led by Anne Libby and her colleagues at the University of Colorado, Denver — found a spillover effect for adults. They found that the 12.4 per 1,000 rate for the diagnosis of depression in 2007 was significantly less than their predicted trend rate of 20.3 per 1,000 people.
The researchers also identified changes in the type of providers who diagnosed depression. In the post-advisory period from 2004 through June 2007, the case finding of depression decreased significantly among both pediatricians and primary care providers.
During the post-advisory period, diagnoses of new episodes of depression by primary care providers also dropped 37% for young adults and 29% for adults.
Other mental health providers who were not psychiatrists — mental health professionals such as psychologists or clinical social workers — was the only provider category that increased following the issuing of the FDA advisory.
Prescriptions for selective serotonin reuptake inhibitors (SSRIs) also declined following the FDA warning. Prescriptions for SSRIs within 30 days of the new depression episode fell by 10% for children and 15% for adults from the post-advisory period through 2007.
The drop in SSRI use, however, did not mean that depressed patients were getting alternative treatments. There was not a statistically significant or clinically meaningful increase in the use of atypical antipsychotics and anxiolytics in the period following the FDA warning.
There was a small increase in the use of psychotherapy within 180 days of diagnosis, but the increase occurred only in adults, the researchers found.
The researchers reported receiving unrestricted research grants from Eli Lilly and Company, Forest Pharmaceuticals, Lundbeck, and the American Foundation for Suicide Prevention.
The findings were published in the June issue of Archives of General Psychiatry.
Source: Archives of General Psychiatry