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University of Colorado Denver | Anschutz Medical Campus

University of Colorado Denver, Newsroom
 

News Release

Antidepressant label warnings raise concerns


 

CHICAGO/AURORA, Colo. (June 1, 2009) – Government warnings about increased suicide risks among children taking antidepressants appear to be associated with unintended and persistent changes in the diagnosis and treatment of depression in both children and adults. The study, conducted by faculty at the University of Colorado Denver’s Schools of Medicine and Pharmacy and the Colorado School of Public Health, appears in the June issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

“In October 2003, the FDA issued a public health advisory about the risk of suicide in pediatric patients taking antidepressants which lead to a boxed warning, package insert and medication guide that were implemented in February 2005,” said Anne Libby, PhD, lead investigator on the study and associate professor of public health and psychiatry at University of Colorado Denver. “The warning was geared toward young adults, ages 25 and younger, and immediately after the 2003 advisory, there was a notable decline in depression diagnosis and treatment using antidepressants. We also saw spillover effects in adult patients, who were not targeted by the warnings.”

To determine whether these unintentional consequences persisted, Libby and colleagues at UC Denver and the Colorado School of Public Health 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 but 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 would have been 15.6 for young adults and 20.3 for adults per 1,000 enrollees; 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,” said Libby.

“Substitution of other forms of treatment was an expected outcome,” said Rob Valuck, PhD, co-investigator on the study and professor of clinical pharmacy in the UC Denver School of Pharmacy. “But antidepressant alternatives—atypical antipsychotics and anxiolytics—did not increase statistically or in clinically meaningful ways.”

The findings suggest that initial unintended consequences of the FDA warnings have continued through 2007. “Substitute care did not occur in pediatric and young adult groups, and spillover to adults has continued, suggesting that unintended effects aren’t temporary—they are substantial and occur among a large national population. Policy actions are needed to correct this,” said Libby.

The University of Colorado Denver is one of three campuses in the University of Colorado system. Located in Denver on the Downtown Campus and on the Anschutz Medical Campus in Aurora, Colo., UC Denver offers more than 100 degrees and programs in 13 schools and colleges and serves more than 28,000 students. For more information, visit the UC Denver Newsroom.

For more information, contact JAMA/Archives Media Relations at 312/464-JAMA (5262) or e-mail mediarelations@jama-archives.org
 
(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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Contact: Tonya Ewers-Maikish, 303.315.6374, tonya.ewers@ucdenver.edu