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Moving Past ‘Black Box’ Warning on Antidepressants

Moving Past ‘Black Box’ Warning on Antidepressants

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The so called “black box” warnings on antidepressants that the medications increase the risk of suicidal thinking in children are doing more harm than good, says a North Shore-LIJ Health System child and adolescent psychiatrist.

The FDA advisories – labeled on such mood-boosting medications as Prozac, Paxil and Celexa since 2004 – continue to scare many parents from having their depressed children prescribed medication and psychotherapy, said Robert Dicker, MD, associate director of Child & Adolescent Psychiatry at North Shore-LIJ Health System’s Cohen Children’s Medical Center. Families often see the black box warning and immediately become firm that they don’t want their children on drugs, he said.

“We’re not only talking about the negative effect of the black box warning on prescription writing and on parents actually taking their child for an evaluation, but we’re also seeing -- with the black box warning -- less children and adolescents being referred for psychotherapy,” said Dr. Dicker, adding that he hopes suicide awareness programs such as World Suicide Prevention Day on Sept. 10 can shed more light on the downside of the black box warning.

A Harvard study published last year in the British Medical Journal found “substantial reductions in antidepressant treatment and simultaneous, small but meaningful increases in suicide attempts” in the years since the FDA issued the black box advisory in 2004.

“We know when we’re talking about diagnosis, depression is the most common diagnosis in kids who are suicidal,” Dr. Dicker said. “If you don’t treat the depression, their risk of suicide increases.”

Worldwide, more than 800,000 people take their own lives each year, according to the World Health Organization. In the United States, the Centers for Disease Control and Prevention reports that there are 12.6 suicide deaths per 100,000 Americans. That rate has steadily increased since 2000.

“We have many studies that indicate real gains from different kinds of psychotherapy for adolescents who suffer from depression,” Dr. Dicker said. “And the best response rates come from the teenagers who receive cognitive behavioral therapy combined with the use of anti-depressant medications.”

Given that the FDA remains committed to keeping the black box warnings on antidepressants, Dr. Dicker encourages parents “to look closely at the negative impact of not treating depression versus the black box warning.”

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