A Warning for Kids on Antidepressants
Concerns over suicidal behavior prompt 'black box' labels

(HealthDay News) -- Worries that antidepressants might put children at increased risk of suicidal behavior have prompted a change in labeling of these mood-enhancing drugs.

Beginning this spring, popular antidepressants are to begin carrying a "black box" label warning of the potential suicide risk. The U.S. Food and Drug Administration ordered the warnings to appear on labels of adult antidepressants most often prescribed to children.

Prozac is the only drug approved for use in children with major depressive disorder, but doctors legally can -- and do -- prescribe other antidepressants to kids.

"The strategy is designed to provide important new information to parents, families and health-care providers in ways to protect depressed children from the increased risk of suicidal thoughts and actions associated with antidepressant drugs," Dr. Lester Crawford, acting commission of the FDA, said at a news conference in Washington, D.C., last October.

Calls for more stringent and visible warning labels began building last year in the wake of a decision by British authorities that effectively banned all antidepressants except Prozac from use in children and adolescents.

In February 2004, the FDA's Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee recommended that labeling highlight the need to monitor people taking certain antidepressants.

Dr. Marvin Lipkowitz, chairman of psychiatry at Maimonides Medical Center in New York City, told HealthDay he favored the recommendations. "The newer drugs have been a boon in treatment of depression," he said. "However, the advertisements and the way people think about the drugs makes them sound as if they are sort of like aspirin for headache. This is an error."

Products including Prozac, Paxil, Zoloft and Celexa belong to a class of medications called selective serotonin reuptake inhibitors (SSRIs). These drugs are considered an improvement over older antidepressants and have been shown to benefit children and adolescents with major depressive disorder, according to the National Institute of Mental Health.

It is extremely difficult to know whether SSRIs boost the risk of completed suicide, the Institute notes, because depression itself increases suicide risk and completed suicides are rare. Controlled drug trials typically include only hundreds of participants, it added, not the thousands need to test for rare events. These trials also usually exclude people deemed at high risk for suicide.

In the meantime, three new studies on the degree of danger these drugs pose to youth have yielded conflicting results.

So what should parents of depressed kids do? Because major depression is a serious condition, the National Institute of Mental Health advises careful treatment, follow-up and monitoring. Specifically:

• Every child should be thoroughly and carefully monitored by a physician to determine if medication is appropriate. A child who receives an SSRI should receive ongoing medical monitoring, with especially close attention paid in the first four weeks that the child takes the drug.

• Parents should obtain a prompt evaluation by a clinician who has experience with these medications if a child exhibits suicidal behavior or other symptoms, including nervousness, agitation, irritability, mood instability or sleeplessness.

• A child already taking an SSRI should remain on that drug if it's helpful but should be carefully monitored by a physician.

• Parents should carefully weigh the benefits and risks of the drugs, and should ensure appropriate follow-up to reduce risks.

On the Web

To learn more about antidepressant use and suicide risk, check with the Mayo Clinic.

By Karen Pallarito
SOURCES: HealthDay News; Marvin Lipowitz, M.D., chairman, Psychiatry Department, Maimonides Medical Center, New York City; Oct. 15, 2004, news release, U.S. Food and Drug Administration, Rockville, Md.; National Institute of Mental Health (www.nimh.nih.gov).
Publication Date: March 31, 2005
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