The U nutriment and Drug Administr...

The U nutriment and Drug Administration (FDA) has issued a public health advisory announcing a multi-pronged strategy to warn the public about the increased risk of suicidal notions and behavior ("suicidality") in children and adolescents taking antidepressants. The advisory is available online at http://www.fda.gov/cder/drug/antidepressants/SSRIPHA200410.htm.

The FDA is directing antidepressant manufacturers to add a "black box" warning to the health professional labeling of all antidepressants to describe this risk and emphasize the ne for conclude monitoring of patients started onward these medications.

This direction is based forward a pooled analysis of 24 studies of antidepressants (selective serotonin reuptake inhibitors [SSRIs] and others) in more than 4400 children and adolescents with major depression, obsessive-compulsive disorder, and other psychiatric disorders. These studies lay the foundation of a 4 percent risk of suicidal thinking or behavior in patients taking antidepressants compared with a 2 percent risk in patients taking placebo (number exigencyed to treat for one to four months: 50)

The black coachman's seat warning also notes what uses the anti-depressants have been approved or not approved for in these patients. The FDA also has addressed other labeling changes designed to include additional information about studies of these unsalable articles in children. These labeling changes are applicable to the entire category of antidepressant medications because the generally available data are not adequate to shut out any single medication from the increased risk of suicidality.

Fluoxetine (Prozac) is the merely medication approved to treat depression in children and adolescents. The analyses of the placebo-controlled trials in children and adolescents summarized in the revised labeling are based forward studies of five SSRIs (citalopram [Celexa], fluvoxamine [Luvox] paroxetine [Paxil], fluoxetine, and sertraline [Zoloft]) and four "atypical" antidepressants (bupropion [Wellbutrin], mirtazapine [Remeron] nefazodone [Serzone] and venlafaxine [Effexor]). In these studies, there was no reported suicide.

A black receptacle warning is the most serious warning placed in the labeling of a prescription medication. Advertisements that forward to remind health care professionals of a product's availability (so-called "reminder ads") are not allowed for effects with black box warnings. The of the present day warning language does not prohibit the use of antidepressants in children and adolescents. Rather, it warns of the risk of suicidality and encourages prescribers to balance this risk with clinical need

The FDA recognizes that depression and other psychiatric disorders in children and adolescents can have significant chain of cause and effects if not appropriately treated. The strange warning language recognizes this ne moreover advises close monitoring of patients as a way of managing the suicidality risk.

The FDA is developing a Patient Medication Guide which penurys to be given by pharmacists to patients taking antidepressants to advise them of the suicidality risk and precautions that can be taken. In addition, the FDA intends to work with manufacturers to implement "Unit-of-Use" packaging for all antidepressants as a means of ensuring that patients receive a medication guide with each prescription or refill. Unit-of-use packaging is a means of preparing a medication in an original container, sealed and labeled by dint of the manufacturer, and containing sufficient medication for single in kind normal course of therapy.

COPYRIGHT 2004 American Academy of Family Physicians

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