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More Concern on Antidepressants in Children

As FDA Considers Their Place, Antidepressant Use Skyrockets Among Italian Youths
WebMD Health News

March 18, 2004 -- The increasing use of antidepressants in children -- and associated worry among some -- is not unique to the U.S. Italian health officials are the latest to express worry over kids being prescribed these drugs.

"The concern is due to the fact that the data supporting the effectiveness and the safety of antidepressant therapy in children and adolescents are still limited -- in particular regarding SSRIs," Antonio Clavenna, MD, tells WebMD. "As a consequence, there is a growing number of youths exposed to medications that could cause harm or be ineffective."

Clavenna, of the Laboratory for Mother and Child Health at Mario Negri Institute for Pharmacological Research in Milan, is worried because his research team notes a nearly fivefold increase in SSRI use among children and teens in Italy in recent years. After reviewing prescription records of more than 500,000 young patients in 2000, he reports in this week's British Medical Journal that three in 1,000 Italian youths take antidepressants -- two thirds of them teenage girls.

Worldwide Use

As in the U.S. and elsewhere, most are being prescribed popular SSRI antidepressants (selective serotonin reuptake inhibitors) such as Prozac, Paxil, Zoloft, and Celexa, which are proven to help adult depression. But some charge there is little evidence of their safety and effectiveness for childhood depression -- but plenty of controversy.

Last summer, health officials in the U.K. and Canada banned the use of Paxil in patients under age 18 after British researchers noted a higher suicide rate among depressed youths taking it. An FDA panel followed with a warning in February -- recommending that the FDA put out a stronger warning about the risk of suicide in kids who take antidepressants.

Since then, the FDA has been examining that and other data, and is expected to decide this summer about the use of antidepressants -- and especially SSRIs -- in children. FDA-designated researchers are now analyzing 24 studies involving more than 4,000 depressed children and nine antidepressants. Some studies suggest the drugs increase suicide risk, while others find no such evidence. In fact, one linked widespread use of SSRIs to a reduced suicide rate in Australia.

Although most SSRIs are not specifically approved as a childhood depression treatment, worldwide, they are considered the first line of defense against depression in all age groups. Prozac is the only SSRI specifically approved by the FDA for use in those under 18.

Two FDA advisory panels met last month to hear from experts and parents, some detailing their children's suicides after starting SSRI treatment and others claiming that the controversial drugs had saved their kids' lives.

Medication Better Than Taking No Action

At least 1 million children and teens in the U.S. are currently taking SSRIs for depression, says child and adolescent psychiatrist David Fassler, MD, who testified before the FDA panels as an expert for the American Psychiatric Association. In the U.S., childhood depression affects about one in 20 kids -- and about one-third of them will attempt suicide at some point during the course of their illness, regardless of their medication.

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