FDA 'black box' on antidepressants called a bad idea

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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."

Those signing included the American Academy of Child and Adolescent Psychiatry, American Association of Suicodology, American Foundation for Suicide Prevention, American Psychotherapy Association and the National Alliance on Mental Health.

After ordering that warnings about the pediatric risk of suicidal tendencies be put on antidepressant labels in 2004, the FDA began analyzing the risk for adults.

Those at risk, the FDA said, are adults between the ages of 18 and 25. The information came from a mass review of 372 studies involving roughly 100,000 patients and 11 SSRI drugs, including Lexapro, Zoloft, Prozac and Paxil.

The FDA's review of the medical literature found that using antidepressants elevates the risk of suicidal thoughts and behavior in young adults but lessens it for seniors.

Although the black-box warning language is largely specific to pediatric patients, it says adults "being treated with antidepressants should be observed similarly for clinical worsening and suicidality," especially during the first few months of treatment.

In July 2005, the FDA issued a public health advisory that said there could be increased suicidal behavior in adults treated with antidepressants.

"All medicines have risks," said Dr. Robinowitz. "But the bottom line is depression is a serious disorder, and there are effective treatments for it ... you don't want to remove access to life-saving treatments."

c Researcher Amy Baskerville contributed to this report.