| nomdeplume1000@yah00.com 2004-09-21, 3:08 am |
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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.
--
Nom dePlume, Ph.D
Why, yes, in fact, I am a rocket scientist.
Guide to Medications for Mental Illness:
http://www.geocities.com/nomdeplume1000
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