FDA warnings led to unintended changes in depression diagnosis

Government warnings about suicidality among children taking antidepressants appear to be associated with unintended and persistent changes in the diagnosis and treatment of depression in children and adults, according to a report in the June issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

“In October 2003 the Food and Drug Administration (FDA) issued a Public Health Advisory about the risk of suicidality for pediatric patients taking antidepressants; a boxed warning, package insert and medication guide were implemented in February 2005,” the authors write as background information in the article. “The warning was extended to young adults aged 18 to 24 years in May 2007. Immediately following the 2003 advisory, unintended declines in case finding and non?selective serotonin reuptake inhibitor substitute treatment were shown for pediatric patients, and spillover effects were seen in adult patients, who were not targeted by the warnings.”

To determine whether these unintentional consequences have persisted, Anne M. Libby, Ph.D., and colleagues at the University of Colorado Denver’s School of Medicine analyzed patterns in a national integrated managed care claims database from July 1999 through June 2007. During this time period, 91,748 children (ages 5 to 18), 70,311 young adults (ages 19 to 24) and 630,748 adults (ages 25 to 89) were diagnosed with depression.

Between 1999 and 2004, the rate of diagnosed episodes of depression increased steadily among each group. “After 2004 the observed national rate of pediatric case-finding fell significantly, with the post-advisory decline persisting such that the rate per 1,000 enrollees in 2007 (3.5) approached the 1999 level (3.2),” the authors write. “Based on the historical trend established in the five years prior to the advisory, the 2007 rate per 1,000 enrollees would have been 15.6 for young adults and 20.3 for adults; the actual observed rate was 9.6 for young adults and 12.4 for adults.”

In addition, primary care clinicians specifically continued to diagnose fewer cases of depression, with a 44 percent lower rate of diagnosis among pediatric patients, 37 percent lower among young adults and 29 percent lower among adults. This trend is particularly important because the general medical sector sees the largest proportion of patients seeking mental health care in the United States, the authors note.

“Substitution of other forms of treatment might have been an expected outcome of a decrease in first-line treatment for the acute phase of depression,” they write. “There was a small but significant increase in the proportion of new depression cases that received at least one visit for psychotherapy within 180 days of diagnosis for adults only. Antidepressant alternatives — atypical antipsychotics and anxiolytics — did not increase statistically or in clinically meaningful ways from their very low base rates in the pre-advisory period.”

The findings suggest that initial unintended consequences of the FDA warnings have continued through 2007, the authors conclude. “Diagnosing decreases persist,” they write. “Substitute care did not compensate in pediatric and young adult groups, and spillover to adults continued, suggesting that unintended effects are nontransitory, substantial and diffuse in a large national population. Policy actions are required to counter the unintended consequences of reduced depression treatment.”

(Arch Gen Psychiatry. 2009;66[6]:633-639. Available pre-embargo to the media at www.jamamedia.org.)

Editor’s Note: Dr. Libby and co-authors Dr. Orton and Dr. Valuck report unrestricted investigator-initiated research grants from Eli Lilly and Company, Forest Pharmaceuticals, Lundbeck and the American Foundation for Suicide Prevention. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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