The FDA May Expand Warning Labels for Antidepressants - Charles Donovan

The FDA may expand warning labels for antidepressants because of fear increases in suicidal thoughts. The proposed changes were made public yesterday( December 12th) by the U.S. Food and Drug Administration.

The changes would expand a warning now on the labels that applies only to children and adolescents treated with the drugs. The proposed changes would expand the labeling to include children, adolescents and adults 24 years and younger.

A special panel is meeting this week to consider these changes. The special panel would make a recommendation to the FDA and then the FDA would issue its final and binding decision early next year.
The panel consists of experts in psychiatry, pharmacology and neuropharmacology.

Also included in the FDA proposes changes is a recommendation that patients of all ages be carefully monitored, especially when beginning antidepressant treatment.

Patients who are depressed and are put on antidepressants should be monitored regardless of FDA recommendations. If you believe that a loved one is at risk of suicidal behavior or thoughts, that patient should be monitored 24 hours a day.

Mental health experts are worried that additional warnings about the risk of suicides linked to antidepressants could curtail their use and ultimately do more harm than good. The FDA may indeed be unnecessarily scaring patients with these warnings that are called "black-box" labels. Patients who are suffering from mental illness tend to be fragile and are sensitive to alarming warnings.

The American Psychiatric Association( APA) does not endorse this type of warning. The APA's concern is that by not simply promoting good standards of care and by putting on a black-box label, the FDA may unwittingly limit further access to care.

Vagus nerve stimulation therapy, which is the only FDA approved long term treatment option for depression, is not associated with increases suicidality in patients who have had the treatment.

Charles Donovan was a patient in the FDA investigational trial of vagus nerve stimulation as a treatment for chronic or recurrent treatment-resistant depression. He was implanted with the vagus nerve stimulator in April of 2001. He chronicles his journey from the grips of depression thanks to vagus nerve stimulation therapy in his book:

Out of the Black Hole: The Patient's Guide to Vagus Nerve Stimulation and Depression

His all inclusive book prepares depression sufferers to make an informed decision about this ninety-minute out-patient procedure. It is a "must read" before you discuss this treatment with your psychiatrist. A prescription for the procedure is required from an M.D. and it is covered by most insurance plans.

He is the founder of the http://www.VagusNerveStimulation.com Web Site and Bulletin.

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