Are Antidepressant Warnings Causing Harm?
Study Shows Warnings About Suicidal Thoughts Led to Fewer Diagnoses of Depression
June 1, 2009 -- Federal warnings about potentially dangerous and even deadly risks of antidepressant drugs may be doing more harm than good, new research suggests.
Since the FDA issued its first in a series of warnings in October 2003 about increased risk of suicidal thoughts or actions in children and teens taking antidepressants, diagnoses of new cases of depression have plunged in youths and adults, according to a study in the June 2009 issue of Archives of General Psychiatry.
What's more, prescriptions written for antidepressants also have dropped significantly, and these "unintended" consequences of the FDA's warnings are continuing, study researcher Robert J. Valuck, PhD, of the University of Colorado Denver's School of Medicine, tells WebMD.
"We think it's worrisome," says Valuck. "The warnings have had a chilling effect on diagnosing depression and on the choice of therapies." And that could be dangerous, he says, because the warnings have frightened parents of children with depression and kept many from seeking help.
The warnings, Valuck tells WebMD, also have given the jitters to pediatricians and other primary care doctors, who often make the diagnoses of depression in children and young adults.
Antidepressants and Suicide Risk
The FDA issued another advisory in October 2004, directing manufacturers to put a "black box" alert -- its highest warning level -- on packaging, advising parents and patients that children and adolescents who use the drugs have an increased risk of suicidal thoughts and behavior. In February 2005, the advisory's recommendations were implemented.
The lead author of the new study, Anne M. Libby, PhD, also of the medical school in Denver, says the warning was extended to young adults 18-24 in May 2007, even though "large and significant declines in depression treatment [already had] spilled over to the adult population."
She says her team analyzed a national integrated managed care claims database covering July 1999 through June 2007, finding that new episodes of depression were found in 91,748 young people ages 5-18, 70,311 adults ages 19-24, and 630,748 people ages 25-89.
Between 1999 and 2004, the rate of diagnosed depression increased in people ages 5-18, 19-24, and 25 to 89, the study shows. But after 2004, the national rate of pediatric diagnoses "fell significantly," and declines have persisted in all age groups.
The researchers write that primary care clinicians have continued to diagnose fewer cases of depression, with a 44% lower rate of diagnosis among pediatric patients, 37% lower among young adults, and 29% among other adults.
The findings could spell danger, Valuck tells WebMD.
"Fewer and fewer are being diagnosed, and fewer prescribed SSRIs," he says. "We are concerned. We believe the FDA should revisit the topic to be more specific."
SSRIs, or selective serotonin reuptake inhibitors, are a common type of antidepressant.