Fair warning on antidepressants

On Tuesday, a Food and Drug Administration advisory panel urged that antidepressants carry explicit warnings about an increased risk of suicidal behaviors in young people. The move is a win for families with depressed children — but only if they and their physicians use the new tool with discretion. The issue of antidepressant use has long been hampered by what was known about the medication but not openly told, and by what was openly told but perhaps not truly understood. For several years, families and some physicians have publicly questioned the drugs' safety. The FDA met this concern, first with a promise of further study, then with suppression of their own drug-safety expert's finding of a link to suicidal tendencies, and finally this week with an admission of the connection. It was neither a responsible nor respectful response. The new warning would come in the form of a black box on the label and in drug advertisements, and a pamphlet that helps parents decide if use is appropriate for their child and that lays out warning signs of suicide. While the warnings are welcome, and overdue, they still offer no definitive answer for worried parents.

Physicians have been prescribing the medication liberally even with what critics might call abandon. This year, spending on antidepressants and behavioral drugs outpaced money spent on antibiotics or asthma or allergy medication. This is especially troubling in the face of clinical trials that failed to show antidepressants' benefit. Doctors can legally prescribe all the drugs, but only Prozac has been shown to be effective for children and is FDA-approved. This is medical science unfolding at its messiest, and it would be easy for any parent to get lost in the maze. That is why we urge caution but not an immediate rejection or embrace of antidepressants for children.

Parents should:

• Arm themselves with research and with reality.
   
• Understand that suicidal tendencies appear to increase when children first go on an antidepressant or when their dosage is increased.
   
• Pay attention to agitated behavior and to talk or writings about suicide.
   
• Take medicating their children seriously, insisting their physician not begin it casually. Counseling and support should not be shortchanged.

That said, parents should not confuse caution with an automatic dismissal of the medication. At the FDA hearing, many families and physicians testified of the drugs' effectiveness and, while advocating for the new warning, the panel emphasized the risk to children was quite small. Placed alongside the estimated 15 percent risk of suicide in depressed youth who receive no treatment, the use of antidepressants can make sense. With all parents, we await the day when depression will be a better understood and more easily treated disease. Wisely used warnings on antidepressants are an acceptable step along that path, but they are no solution.

Antidepressants in use today have been developed for and tested on adults. We need research aimed at children and a clean, objective space — free of drug company marketing and FDA stalling — to view it in.

16 September 2004
http://www.enquirer.com/editions/2004/09/16/editorial_ed1a.html

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