A proposal that antidepressants carry a prominent warning that the drugs can increase the risk of suicide in children has made some family practitioners and pediatricians hesitant to prescribe the medications.
But doctors said they will likely send young patients to psychiatrists, many of whom believe in the drugs and will continue prescribing them.
Based on a recommendation this week by two federal advisory panels, the Food and Drug Administration is likely to order drug makers to include the most stringent warning label -- a "black box" -- in packaging, advertisements and information sent to doctors.
The committees analyzed data from nearly two dozen clinical trials and concluded that minors given the drugs were 2% to 3% more likely to have suicidal thoughts than those given placebos. The same trials also failed to show that the drugs worked in children, with the exception of Prozac. Nobody in the clinical trials committed suicide.
Some psychiatrists said they were unlikely to be dissuaded from writing prescriptions. They consider the trials too limited in scope and argue that it is far from clear that the drugs do no good. In 2002, 10.8 million antidepressant prescriptions were for children, about 7% of the total, according to the FDA.
The recommendation from the FDA committees "is going to force more discussion between doctors and patients," said Dr. Carl Feinstein, a child psychiatrist at Stanford University. "Doctors are reluctant to change prescribing practice because they have a lot of experience that tells them the drugs are effective."
The most important message from the debate, doctors said, is that young patients taking the medications should be closely monitored, particularly when they are starting a regimen or changing dosage.
That is why nonpsychiatrists said they would be more likely to defer to their expert peers rather than prescribe the drugs themselves.
According to the FDA's most recent statistics, from 2002, psychiatrists already write about 65% of antidepressant prescriptions for people under age 18.
Family practitioners and pediatricians account for just over 25%. Some of those doctors, such as Dr. Eleanore Meyer, a Santa Monica pediatrician, prescribe the drugs only in consultation with psychologists or social workers, who provide therapy but are not licensed to offer medication.
With the new proposal, she said she would refer depressed patients to psychiatrists. "We're going to be pretty hesitant to use these medicines," she said.
When British medical authorities last year warned that the antidepressant Paxil increased the risk of suicide in youths, Meyer ordered that her patients be weaned off it.
"It's really hard when a patient is already on a medicine [and] doing well," she said.
But it is far from clear that a labeling requirement would result in fewer overall prescriptions of antidepressants for children. After the FDA ordered drug makers to include a milder warning of a possible suicide link in March, antidepressant prescriptions for minors rose at the same pace as prescriptions overall -- about 7%.
Drug industry analysts do not believe a black box warning would have much effect on demand for antidepressants.
Other black box warnings have led to a shift to drugs without the warning and not an overall decline in prescriptions for a particular class of drugs. But the current recommendation would apply to all antidepressants. There are no alternative drugs.
"This time next year there should be very little difference in the growth rate for these drugs in the U.S.," said Neil Sweig, a pharmaceutical analyst at Fulcrum Global Partners, a stock research firm in New York.
Nor is the warning likely to spark a legal backlash that could stall sales, experts said. Suicide is a complex behavior related to many factors, and it would be difficult to prove in a specific case that a drug caused an already depressed person to commit suicide.
"Maybe in the entire country you can find 30 children who died from this, and that is 30 too many, but it isn't something that all of a sudden is going to gin up an industry for the plaintiffs' bar," said Jonathan M. Zasloff, a UCLA law professor.
While the warnings could deter some parents from agreeing to put their children on antidepressants, most would likely follow the advice of their physicians, doctors predicted.
It could, however, become more cumbersome for children to get the medications.
Managed-care administrators may find themselves having to process more referrals to psychiatrists. There are just 6,000 child psychiatrists nationwide and 1 million to 2 million minors taking antidepressants.
Nonpsychiatrists will eventually have to "educate themselves as to what constitutes a major depression," said Dr. Richard Gorman, a pediatrician in Baltimore and a representative of the American Academy of Pediatrics. Antidepressants are not for people who are "blue or a little sad for a while."
Dr. Donald Errante, a behavioral pediatrician in Greenbrae, Calif., has been giving parents an information sheet warning of the side effects of the antidepressants he prescribes to dozens of patients. Now, he is considering having them sign a waiver accepting the risks.
"I can live with the black box warning," he said, "as long as they don't take the drugs away."