FDA 'Black Box' on Antidepressants Called a Bad Idea; Mental Health Advocacy Groups Fear Patients May Be Scared Off

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Byline: Joyce Howard Price, THE WASHINGTON TIMES

The president-elect of the American Psychiatric Association will tell an advisory panel of the Food and Drug Administration today that putting black-box warnings on antidepressants taken by adults highlighting potential suicide risks would be a mistake.

Dr. Carolyn B. Robinowitz will ask the FDA's Psychopharmacologic Drugs Advisory Committee not to repeat what it did two years ago when it required strong warnings on popular antidepressants known as selective serotonin reuptake inhibitors (SSRIs) when the drugs are used by children and teens.

"The actual risk [for increasing suicidal tendencies in adults associated with SSRIs] is still to be determined," Dr. Robinowitz said in an interview yesterday. "But we know there is a 15 percent higher risk for suicide in patients with untreated depression, and we have seen a decline in suicides since SSRIs have been available.

"Black-box warning labels cause black-box panic, and we know the warnings currently on anti-depressant labels have interfered with many families being treated effectively [for depression] out of fear."

She said the labels aren't necessary as long as doctors alert patients taking SSRIs of possible side effects and monitor them.

Yesterday, the APA and 14 other nonprofit national mental health advocacy and medical professional groups signed a letter to the FDA, reminding it about the many families "unnecessarily scared away from treatment" for depression as a result of the pediatric warnings on SSRIs.

Pointing out that 19 million Americans annually face "this debilitating disease" [depression], the letter said that "untreated depression carries a much greater risk than any potential risk of adverse effects of medication. …