Beware of Suicide with Depression Drugs - FDA
Mon Oct 27, 5:46 PM ET
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WASHINGTON (Reuters) - The U.S. Food and Drug Administration (news - web sites) 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 (news - web sites), 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.