Depression Diagnoses Dropped After FDA Antidepressant Warnings

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Following the government’s 2003 warnings about suicide among children taking antidepressants , it seems that unintended and ongoing changes have been taking place in the diagnosis and treatment of both adult and pediatric depression. The findings appear in this month’s issue of Archives of General Psychiatry and have some experts concerned that depression treatment might be affected.

According to background information on the article, “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 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.”

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 for an eight-year period from July 1999 through June 2007. Libby discovered that in this time period, 91,748 children (ages five to 18), 70,311 young adults (ages 19 to 24) and 630,748 adults (ages 25 to 89) were diagnosed with depression.

The research also revealed that from 1999 through 2004, the rate of diagnosed episodes of depression increased steadily in each group; however, after the warning, in 2004, “the observed national rate of pediatric case-finding fell significantly,” said the authors. “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.”

These findings, said the Associated Press (AP), looked at about 100 managed care plans and over 55 million patients and found, said US News and World Report, that new diagnoses of depression cases significantly dropped in this country following the warning. Regarding the change, Robert J. Valuck—study co-author and a professor of clinical pharmacy at the University of Colorado Denver’s School of Pharmacy—said, “We don’t know why; we just do know after the warnings these things did change, so it had an effect on treatment patterns for depression.”

Following the FDA warning and based on trending data, it seems that primary-care physicians wrote 44 percent fewer SSRI prescriptions for pediatric patients and 37 percent fewer for young adults, said US News. What is of concern is that there is no correlative upswing in “alternative medications or psychotherapy” replacing the SSRI decline, noted US News.

“It does look concerning, that the patients are not getting treated,” said John F. Curry, director of clinical psychology training at Duke University Medical Center. The authors concluded that the warning’s initial unintended consequences continued through 2007, saying, “Diagnosing decreases persist … Substitute care did not compensate in pediatric and young adult groups, and spillover to adults continued … Policy actions are required to counter the unintended consequences of reduced depression treatment.” The question remains if the warnings, meant to help patients, are actually increasing cases of suicide because depression diagnoses and treatment have been affected, said US News. Of note, a 2008 study conducted in Ohio revealed that “youth suicides” increased in 2005 and 2005 following a 15-year decline, US News pointed out.

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