Magazine article Clinical Psychiatry News

Suicidality Reports Prompt Advisory: FDA Sets Stage for Debate on Antidepressants, Kids; Expert Panels to Discuss Data Next Year

Magazine article Clinical Psychiatry News

Suicidality Reports Prompt Advisory: FDA Sets Stage for Debate on Antidepressants, Kids; Expert Panels to Discuss Data Next Year

Article excerpt

The Food and Drug Administration's public health advisory about the reports of suicidality among pediatric patients treated with antidepressant drugs for major depressive disorder is a result of a preliminary review of such reports in patients on various antidepressants.

The FDA released the advisory to alert physicians to reports of suicidality in clinical studies of various antidepressants in pediatric patients with major depressive disorder (MDD). Although cases of suicidality "are not unexpected in patients with MDD, preliminary data suggest an excess of such reports" among patients who have been on some of those drugs compared with those on placebo, the advisory states. The advisory emphasizes that these data "do not clearly establish an association between the use of these drugs and increased suicidal thoughts or actions by pediatric patients," but that an increased risk cannot be ruled out at the present time.

The reports were in patients on the following antidepressants: selective serotonin reuptake inhibitors (SSRIs), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), and citalopram (Celexa); as well as venlafaxine (Effexor), mirtazapine (Remeron), and nefazodone (Serzone).

All eight brand name antidepressants have been studied under the pediatric exclusivity provision of the FDA Modernization Act of 1997, which created a financial incentive for manufacturers to study their products in children.

There were no reports of completed suicides in the 20 placebo-controlled trials of these drugs in more than 4,100 pediatric patients. Cases of suicide attempts and completed suicides in pediatric patients have been reported in the press and in medical journals but "are very difficult to interpret, in the absence of a control group, as these events also occur in untreated patients with depression," the advisory says.

The FDA's Psychopharmacologic Drugs Advisory Committee and a pediatric subcommittee will hold a joint meeting in February, when the data and possible regulatory actions will be discussed by the panels, made up of outside experts in the related fields. …

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