Updated June 08, 2015.

September 14, 2004

A U.S. Food and Drug Administration (FDA) commission voted 15-8 today to recommend that the FDA require makers of SSRI antidepressants to add a "black box" label warning that the drugs can be linked to suicidal thoughts and behavior in children and adolescents. Such warnings, highlighted in a black box, are the toughest that can be ordered. All magazine and television ads would also be required to carry the warning text.

The panel reviewed published and unpublished research on these medications and concluded that 2-3 out of every 100 young people treated with antidepressants might be at increased risk of suicidal behavior. The types of problems found ranged from from writing a suicide note to attempting an overdose.

The panel found problems in all nine drugs studied, including Prozac (Eli Lilly & co.), Paxil and Wellbutrin (GlaxoSmithKline), Zoloft (Pfizer), Celexa (Forest Laboratories), Effexor (Wyeth), Luvox (Solvay), Remeron (Akzo Nobel) and Serzone (Bristol-Myers Squibb). Serzone is no longer marketed in the U.S. While Lexapro and Cymbalta were not named in press reports, they could be subject to the same requirements.

Some members of the panel voted against the recommendation, warning that the risk of suicide from untreated depression is probably greater than the increased risks posed by these medications.

I believe that these warnings will bring a needed balance back to the treatment of youth depression.

With the exception of Prozac, none of these medications are FDA-approved for treatment of depression in children. Numerous studies have shown that psychotherapy is also effective for depression, and that the combination of medications and psychotherapy may work even better.

Most antidepressant prescriptions are written by family practitioners and they are most commonly written without a concurrent referral for psychotherapy. This is not the best approach if the patient is a child or adolescent.

If your child or teenager is depressed, get them professional help. Your family doctor is a good place to start, and a school guidance counselor can also help. If your doctor prescribes antidepressants, ask him or her about psychotherapy as an alternative, or as something to try in conjunction with the medications.

Last updated 11/5/05