A series of public hearings by the Food and Drug Administration beginning Monday focuses on a difficult question, in which parents who blame the drugs for children's deaths are expected to face families who credit the same pills for saving lives.
Depression occurs in about 10 percent of youth and can lead to suicide, especially if untreated. Some 1,883 10- to 19-year-olds killed themselves in 2001, and specialists say there are 10 to 20 attempts for every suicide.
For adults, antidepressants clearly alleviate major depression, the FDA stresses.
But medicines can work differently in children. The agency has approved only one treatment — Prozac, the best known of a family of popular antidepressants called SSRIs — to alleviate pediatric depression, saying its benefits outweigh side effects.
Still, it is legal for doctors to prescribe adult medicines to children even if the FDA has not formally approved pediatric use, and child antidepressant prescriptions rose dramatically in the 1990s. The FDA ordered other manufacturers to submit research on how their drugs affect children and teenagers.
Last summer, British health authorities acted on the first of those findings, declaring that no depressed patient should use the SSRI drug Paxil, sold in Britain under the name Seroxat.
In October, the FDA warned that doctors should use a list of SSRIs and closely related competitors only with great caution in depressed children. Studies don't clearly prove a link with suicide, but it was impossible to rule out, the agency said.
In December, Britain went much farther, declaring an entire list of antidepressants unsuitable for children. Prozac was the only exception.
No suicides have occurred in studies encompassing 4,000 children. Preliminary data, however, suggest that suicidal behavior and attempts, while infrequent, might be at least twice as frequent among some antidepressant users. Britain put the risk at around 3.2 percent of children given the drugs, compared with 1.5 percent of those given dummy pills.
The FDA is analyzing those studies but doesn't expect to complete its work until summer.
The reports of suicidal behavior are a hodgepodge difficult to sort out, said Dr. Russell Katz, the FDA's neurologic drugs chief. Some cases counted as unintentional drug overdoses may not have been, for example, while others termed suicidal were caused by a mental illness called self-mutilation, where children make small cuts over their bodies. Sorting out just what happened is crucial to settling the issue, Katz said.
For Monday's hearing, the FDA brought together its scientific advisers to ask if it is analyzing the research appropriately, and if families or doctors need additional advice in the meantime.
It's a debate eliciting strong emotions.
The American College of Neuropsychopharmacology, considered the field's top specialists, last month declared evidence that links SSRIs to suicide too weak to justify not using them. The group points to evidence that suicides have dropped as SSRI use increased around the world, and to autopsy studies that show most suicides hadn't taken an anti-depressant, or the right dose, just before their deaths.
On the other side, critics claim SSRIs sometimes cause agitation and urgent anxiety, called akathisia, that could make certain people suicidal. Dr. David Healy, a Welsh physician who pushed for Britain's crackdown, says even he prescribes the drugs, but that they must come with warnings so doctors can monitor children for signs of trouble.