Rense: Anti-Depressants May Increase Teen/Child Suicides

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Anti-Depressants May

Increase Teen/Child Suicides

10-28-3

 

WASHINGTON (Reuters) - The U.S. Food and Drug Administration alerted

doctors on Monday about reports that antidepressants might raise the

risk of suicide in children and teen-agers with major depression.

 

While there is no evidence to show most antidepressants could cause

young patients to commit suicide, doctors need to carefully watch

them, the FDA said.

 

Only one drug, fluoxetine, sold by Eli Lilly and Co. under the name

Prozac, is approved for treating pediatric depression. But doctors

are free to prescribe any approved drug and several are being tested

in younger patients.

 

" The data do not clearly establish an association between the use of

these drugs and increased suicidal thoughts or actions by pediatric

patients, " the FDA said in a statement.

 

" Nevertheless, it is not possible at this point to rule out an

increased risk of these adverse events for any of these drugs,

including Paxil (paroxetine). " Paxil is made by GlaxoSmithKline

Plc .

 

FDA Commissioner Dr. Mark McClellan said the situation showed better

systems are needed for reporting drug side effects. Doctors

voluntarily report side effects to the FDA or a drug manufacturer if

and when time permits.

 

" We need a more efficient and effective program to uncover problems

early, " McClellan told a meeting of the Institute of Medicine, an

independent group that advises the federal government on health

matters. " We are working to do this at FDA. We are working to

complete active reporting. "

 

Electronic medical records linked directly to an FDA database would

help do this, he said, allowing computers to automatically collect

data as it is noted in a patient's record.

 

The FDA said there was not enough information to tell whether

patients taking antidepressants were more likely to try to take

their own lives.

 

" The labeling of antidepressant drugs already carries precautionary

language that the possibility of a suicide attempt is inherent in

major depressive disorder and may persist until significant

remission occurs. Close supervision of high-risk patients should

accompany initial drug therapy, " the FDA advised.

 

It said no one should stop taking the drugs abruptly, and not

without consulting a doctor.

 

The FDA said it had reviewed reports about eight antidepressants --

Paxil; Prozac; citalopram, sold by Forest Laboratories under the

brand name Celexa; fluvoxamine, sold by Belgian drugmaker Solvay

under the name Luvox; mirtazapine, sold by Akzo Nobel's

pharmaceutical unit Organon as Remeron; nefazodone, sold by Bristol-

Myers Squibb as Serzone; sertraline, sold by Pfizer under the name

Zoloft; and venlafaxine, sold by Wyeth under the name Effexor.

 

" FDA is aware of press and medical journal reports of suicide

attempts and completed suicides in pediatric patients receiving

antidepressants, and many such reports have also been submitted to

FDA as spontaneous reports, " the agency said.

 

But it said it is hard to tell whether the drugs caused the

suicides, because depression is the leading cause of suicide.

 

The FDA has scheduled a meeting on Feb. 2, 2004, of the

Psychopharmacologic Drugs Advisory Committee and the Pediatric

Subcommittee of the Anti-Infective Drugs Advisory Committee.

 

Experts say an estimated 750,000 U.S. adolescents suffer from

depression and 500,000 attempt suicide every year. About 1,700

succeed.

 

 

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