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.

“Probably the worst thing parents can do if they suspect their child has depression is nothing at all; the biggest risk is to be left untreated,” he tells WebMD. “The FDA is doing the right thing, because this is a very serious issue and we don’t want to make a mistake in either direction. But with all this media attention, sometimes I am concerned that parents may become reluctant to get any help for their kids.”

His advice: “If you see signs that your child might be depressed or you are concerned, get a good evaluation from a trained mental health professional,” says Fassler, of the University of Vermont. “There are treatments other than medication. Certain forms of psychotherapy, on their own, are very effective.”

Even with medication, he says counseling should be part of a multi-pronged approach to effective treatment; often, it’s not. “But in my own review of data, I’m not convinced there is an increased risk of suicide from SSRI use.”

And he’s not alone. The American Academy of Child and Adolescent Psychiatry says SSRIs can be effective in treating childhood depression. And in January, an American College of Neurophsychopharmacology Task Force found no evidence of an SSRI-suicide link after reviewing clinical trials, epidemiological studies, and toxicology results from autopsies of teenaged suicide victims. Its review of 49 adolescent suicides indicated that 24% of those kids had been prescribed antidepressants, but none had any trace of SSRIs in their system at the time of their death.

Still, Clavenna has other concerns. “Apart from the risk of suicide, evidence is lacking on long-term safety,” he tells WebMD. “Unfortunately, the clinical trials performed so far followed children for only a few weeks of therapy, so data regarding long-term safety are lacking. At least two months is needed to evaluate the effects of treatment on depressive symptoms.

“All antidepressants act on the central nervous system, and the possible long-term effects on a growing individual, on a growing body, on a growing nervous system need to be taken into consideration.”