WASHINGTON (Reuters) – The U.S. Food and Drug Administration issued a public health advisory on Monday to alert doctors to reports that children and teen-agers with major depression thought about or attempted suicide in several clinical trials of antidepressants.
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.
“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 .
“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 certainly not without consulting a doctor.
The FDA said it had reviewed reports about eight antidepressant drugs — Paxil, Prozac, citalopram, fluvoxamine, mirtazapine, nefazodone, sertraline, and venlafaxine.
“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 actually caused the suicide, 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.