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Are Antidepressant Warnings Causing Harm?

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.

Consequences of Fewer Depression Diagnoses

The danger is that people who need to be treated for depression may neither be receiving guidance nor prescriptions from doctors, or even seeking it, Shannon Croft, MD, assistant professor of psychiatry at Emory University School of Medicine in Atlanta, tells WebMD.

“There may be more reluctance among primary care doctors to treat depression,” he says. “The principle of the warnings is reasonable, but the way the warnings have been perceived is tragic.”

He tells WebMD that many people who need treatment aren’t getting it, and many parents are afraid of having their children take SSRIs.

Croft says SSRIs, when used properly, are “good medicines” that may carry “small risks, which is true of all medicines,” but that the public reaction — among some doctors and individuals — has been overwrought.

Valuck tells WebMD that failing to prescribe SSRIs to youngsters who need it may be more dangerous than putting them on the medications.

Crystal Rice of the FDA’s Center for Drug Evaluation and Research says in an emailed statement that the FDA’s intent in adding warnings was to “fully inform prescribers” of risks and benefits and “not to discourage appropriate prescribing.”

“As well, it is important to note,” the statement reads, “that the advisory committee recommended that balancing language be added to the boxed warning to make sure prescribers understand that depression itself is a serious illness that is associated with suicidal thoughts and actions.”

Croft says he worries that the public’s overreaction to the FDA advisories and warnings may cause an increase in suicides.

A 2007 study published in the American Journal of Psychiatry not only showed a steep drop in antidepressant prescriptions for children and teens, but an unprecedented spike in child and teen suicides.

Valuck says new suicide data for 2006 will be available soon and will be analyzed for correlations with declines in diagnosis and drug treatment.

Croft is more blunt, asserting that “the reaction to the black box warning could lead to more suicide.” The warning “has caused this furor, which is tragic because people are not getting treated and are afraid of trying to get treated.”

“While the trends presented by the authors [Valuck, et al.] are a concern … it isn’t clear what the solution would be even if the agency [FDA] did not conclude that there is some connection between the warnings and these trends,” Rice’s statement says. “It’s hard to argue with alerting prescribers when the agency sees an important risk. Broader education about the correct interpretation of warning language might be one approach.”

Meantime, the FDA says it will continue to examine impacts of warnings and study the situation.

Libby and Valuck both report receiving research grants from the drugmakers Eli Lilly, Forest Pharmacueticals, and Lundbeck. Those companies are makers of SSRIs.

Posted by: Dr.Health

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