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Anti–depressants and labels
Eye on FDA, 12-14-06

Eye on FDA, an FDA related blog, published a very thoughtful post on recent FDA advisory committee hearings that explored strengthened suicide warning labels for antidepressant drugs.

At issue is whether or not stronger labeling should be added to anti–depressants warning of the potential for drugs to raise suicidal ideation or suicides in those taking the drugs. The outcome was a recommendation for stronger labeling.

The treatment of people suffering from depression is a very complex issue and one that is not easily addressed by studies, and risk management interventions, of the treatments for non–mental health diseases. There are a number of other factors at work.

First, depression is caused by many factors, often acting in concert. It has no single cause that is easily addressed by a pill. Second, consider that the population of those suffering from a condition that, by its very nature may cause sufferers to be pre–disposed to these thoughts and actions. But consider also the many complex factors that go into the treatment of depression.

There is still a stigma on mental illness in this country. The very idea that one has crossed a line in treatment, to seek help with medical intervention, is a big line to cross for many. It is an admission of a problem that society stigmatizes. Many people on anti–depressants would not want to admit it. Seeking treatment may signify to many that they have a serious problem—a milestone that can be a heavy burden.

And that leads to another factor—the very thought of taking the step to take drug therapy may be saved by many as a last resort or last hope. If the drug does not work, that alone may prompt a person to a position of greater hopelessness. It may not be the drug, but the failure of the drug. For some, anti–depressants work for a time, and then diminish in their effectiveness. The thought then of returning to a life of depression may be too much for some to bear...

I am admittedly a layperson. But it appears to even the most casual observer that it is a lot to expect of labeling to convey the complexity of both risk and benefit in the use of anti–depressants—especially where we are not talking about the medication alone, but the condition and the level of mental health understanding of the prescriber, who is most likely a physician and not a psychiatrist.

A Black Box Warning may serve notice to a prescriber, but until there is a great deal more study in all the nuances of the treatment of depression, a label alone cannot answer the many questions that may persist. In short, I'm not sure that it is the class of drugs that needs re–labeling as much as the condition that they treat.

Project FDA.
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