Caution Urged on Antidepressants and Children

Parents asked to delay treatment changes as FDA weighs label revisions

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HealthDay Reporter

MONDAY, Aug. 23, 2004 (HealthDayNews) -- While U.S. health officials consider imposing more warning labels on antidepressants used by children, experts recommend that parents make no treatment changes without consulting their child's doctor first.

While the new warnings won't take effect right away -- if at all -- specialists say that stopping the medication won't help, especially if the drug appears to be helping the child.

"Certainly I can understand parents' alarm from this, but I think if the child is under the care of a child psychiatrist and seeing the psychiatrist -- and hopefully a therapist -- frequently, and this means at least once a month, I think this can be managed," said Dr. Kathleen Malloy, attending psychiatrist in the child and adolescent outpatient service at Maimonides Medical Center in New York City. "I don't think this is necessarily a reason to take a child off of medication if it seems to be helping."

"At this point, I would say there is a significant signal there that we need to understand," added Dr. David Fassler, a child and adolescent psychiatrist in Burlington, Vt., and clinical associate professor of psychiatry at the University of Vermont College of Medicine. "Although there may turn out to be an increased risk of adverse effects for some children, my own sense is that we will find that for most kids there is potential for help."

The U.S. Food and Drug Administration announced on Friday that it had revisited data regarding antidepressants and suicidal thinking and behavior in children, and said the data may have enough merit to warrant new labels. Specifically, an analysis by senior FDA epidemiologist Dr. Andrew Mosholder found that, overall, children using antidepressants were 1.8 times as likely to have suicidal tendencies as depressed children taking placebos.

This is just the latest chapter in a controversy dating back to last year, when British health officials declared that all antidepressants except Prozac should not be used in children and adolescents.

The risk of suicidal thoughts in children and adolescents taking antidepressants is a bit of a chicken-and-egg situation: It is difficult to determine if the thinking and behavior is due to the drugs or to the underlying depression.

Regardless, earlier this year two expert advisory committees to the FDA recommended that labeling be changed to reflect the need to monitor all patients more closely. The agency then asked manufacturers to change the labels of 10 drugs.

The FDA will seek advice on the latest information at a public meeting of the FDA's Psychopharmacologic Drugs and Pediatric Advisory committees, scheduled for Sept. 13 and 14. It's not clear what language would be used in new warnings if they were implemented.

The current analysis presented by Mosholder was based on 25 studies involving 4,000 children and adolescents and eight antidepressants. The analysis, however, is far from the last word, Fassler said.

"The data is interesting, but far from definitive," he said. "First of all, in all of the studies that were reviewed, there were no actual suicides. Second, some of the studies with the same medication showed very significant differences. In one study there appeared to be an increased risk of suicidal thinking or behavior which wasn't present in another. None of these studies were really conducted specifically to answer these questions. They were re-analyzing data that was really collected for other purposes.

"My hope is that the FDA will look very closely at the data and will make its decision based on the science of the information currently available," Fassler continued. "Personally, I think the existing warnings may be sufficient. I would certainly be concerned about any kind of ban or limitation on the ability to use these medications, because physicians really need the ability to use the full range of treatment options."

The FDA plans to post its analysis of the data on antidepressants, children and suicide on its Web site.

More information

Visit the American Academy of Child & Adolescent Psychiatry for more on FDA developments.

SOURCES: David Fassler, M.D. child and adolescent psychiatrist and clinical associate professor of psychiatry, University of Vermont College of Medicine, Burlington; Kathleen Malloy, M.D., attending psychiatrist, child and adolescent outpatient service, Maimonides Medical Center, New York City; U.S. Food and Drug Administration statement

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