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Health

FDA Backs Warnings
on Antidepressants for Children

FRIDAY, Sept. 17 (HealthDayNews) -- The U.S. Food and Drug
Administration says it "generally supports the recommendations" of two
advisory panels that antidepressants can raise the risk of suicidal
behavior in some children.

As a result, it "has begun working expeditiously to adopt new labeling
to enhance the warnings associated with the use of antidepressants," the
FDA said in statement released late Thursday.

On Tuesday, one of the panels voted 15-8 to urge the agency to require
a "black box" warning, the strongest of its kind for prescription drugs,
to highlight the potential risk to depressed pediatric patients.

The panel said the safety concerns applied to all nine drugs that were
studied. They are Prozac, Paxil, Wellbutrin, Zoloft, Celexa, Effexor,
Luvox, Remeron, and Serzone, a drug that was taken off the market earlier
this year although generic versions are still available. Most are
selective serotonin reuptake inhibitors (SSRIs), though Serzone,
Wellbutrin, Effexor, and Remeron are not.

In response to the FDA statement Thursday, the American Psychiatric
Association said "by calling attention to the need for caution in
prescribing antidepressants in this population and by calling for more
research, the FDA has provided a valuable service in protecting the safety
of the public."

The APA's statement carried some qualifications, however. It commended
the advisory committees "for recommending that the FDA maintain access to
antidepressant medications," saying the drugs, as part of a comprehensive
treatment plan, "can be extremely helpful and even lifesaving for many
young people struggling with depression."

The APA also cited the split vote on the panel's recommendation for a
"black box" warning, saying that the dissenters' concerns that it might
limit treatment "are valid and should be taken into account by the FDA as
it proceeds."

"We believe the biggest threat to a depressed child's well-being is to
receive no care at all," the APA said.

The FDA panels that issued the recommendations Tuesday were the
Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory
Committee.

A recent FDA analysis concluded that only two or three of every 100
young people treated with antidepressants run the risk of suicidal
thoughts or actions, and that the risk had been confirmed in controlled
clinical trials of some of the drugs.

But the stronger warning will apply to all antidepressants, the FDA
said, "since the available data are not adequate to exclude any medication
from an increased risk."

An advisory panel determined that data on suicidal behavior varied
among drugs, "but we are unable to conclude that any single agent is free
from risk," the FDA said.

Panel members also noted that studies have failed to show that most of
the antidepressants are effective for children. Only Prozac, available
generically as fluoxetine, is approved by the FDA for pediatric use.

More information

To read the FDA statement on the two committees' recommendations, click
here.

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