Advisories led to 'unintended consequences,' researchers say
MONDAY, June 1 (HealthDay News) -- Newly diagnosed cases of depression in America have dropped sharply since the government's warning of an increased risk of suicidal behavior among children and teens taking antidepressants, a new analysis finds.
Researchers at the University of Colorado say the U.S. Food and Drug Administration's advisories about the use of selective serotonin reuptake inhibitors (SSRIs) appear to be associated with "unintended" and "persistent" changes in the diagnosis and treatment of depression, especially in children and teens. They also observed a "spillover effect" on adult depression care.
"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," said study co-author Robert J. Valuck, a professor of clinical pharmacy at the University of Colorado Denver's School of Pharmacy.
The report appears in the June issue of the Archives of General Psychiatry.
From the time the FDA issued its warning in 2003 through June 2007, primary-care physicians wrote 44 percent fewer SSRI prescriptions for pediatric patients than historical trends predicted, and 37 percent fewer for young adults. Yet there was no change in alternative medications or psychotherapy to compensate for the decline in SSRI prescriptions for these patients.
"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 in Durham, N.C.
In October 2003, the FDA warned about the increased risk to children and teens of taking SSRIs, citing an increased risk of attempted suicide and suicidal behavior. A little over a year later, the agency directed pharmaceutical manufacturers to add a "black box" warning to medication labels, urging close monitoring of patients taking these drugs.
In May 2007, the FDA extended warnings on antidepressants to young adults aged 18 to 24.
The FDA's intent was to avert the use of these drugs in certain cases where they could be risky, Valuck explained. "We're also concerned, though, that the policies are kind of blunt instruments and can have unintended effects that go beyond maybe what the FDA was even hoping they would do," he added.
In an earlier study published in 2007, Anne M. Libby, Valuck and colleagues reported a significant reduction in diagnosis and treatment of pediatric depression. But some wondered whether that pattern was just a blip.
As a follow-up, the team examined trends over time using health insurance claims data for more than 91,000 children, 70,000 young adults and 630,000 adults diagnosed with depression.
Among the pediatric population, the national rate of diagnosed episodes of depression rose steadily from 1999 to 2004 before returning to 1999 levels. Diagnosis rates went below historical levels for young adults and adults, too.
What remains unclear is whether the well-intentioned warnings will have the perverse consequence of boosting suicidal behavior by impeding depression diagnoses and treatment.
If the results of a 2008 study are any indication, that might indeed be the case. In that report, Ohio researchers found that youth suicide rates increased in 2004 and 2005, after 15 years of decline.
"Some people say it's a good thing that [diagnoses and treatment rates are] falling and some people say it's a bad thing, and the $64,000 question is, 'What does it lead to?'" Valuck said. "A number of people are studying that."
In Curry's view, there's been an overreaction to the risk of suicidal behavior.
"Primary-care doctors and other health-care providers need to be given the full story about what the level of risk is with SSRIs and what are some of the ways to mitigate that risk," he said. "There is a risk; it's a small risk, and it can be mitigated by careful monitoring and combining antidepressant treatment with psychotherapy."
Parents and caregivers can learn more about antidepressants for children and adolescents by visiting the National Institute of Mental Health.
SOURCES: Robert J. Valuck, Ph.D., R.Ph., professor, clinical pharmacy, University of Colorado Denver, School of Pharmacy; John F. Curry, Ph.D.; professor and director, clinical psychology training, Duke University Medical Center, Durham, N.C.; June 2009, Archives of General Psychiatry
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