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Are Antidepressant Warnings Causing Harm?

Study Shows Warnings About Suicidal Thoughts Led to Fewer Diagnoses of Depression

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.

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