Thursday, December 14, 2006

FDA to Issue Stronger Warning on Antidepressants

According to the LA Times:

"A Food and Drug Administration federal panel Wednesday recommended the agency issue its strongest possible warning to alert patients and doctors that antidepressants can increase the risk of suicidal thoughts and behavior in young adults. The panel called for placing the so-called black-box warning on product labels and in medication guides distributed to patients.
Following the vote, FDA officials said they intended to expand the warning to include young adults."

I will need more time to think this one over, but it is certainly more than I expected. I thought nothing would happen. I am sticking with my earlier comments that the FDA review was selective in the data it included, and its trust of industry to release all relevant data was likely naive at best. Since I have not seen data that has done more than break age down into adult versus child/adolescent prior to the release of the FDA data, I really don't know what to make of it. If the data are accurate, it's certainly interesting that age has such an impact upon the drugs' propensity to sometimes cause suicidality.

My final point, for now, is that the whole panic over black box warnings is overblown. Dr. Carol Rabinowitz, president of the American Psychiatric Association, has been quoted on a few occasions saying that black box warnings will lead to less people receiving treatment, and this will increase rates of suicide. My response is that people have a right to know the risks of treatment.

For example, suppose a patient named Bill is prescribed an antidepressant. Within two weeks, he becomes agitated and suicidal. If his physician does not warn him, at the time of prescription, that there is a small chance that the drug will cause him to feel agitated and/or suicidal, then he may believe that the new feelings of suicidality are due to his depression getting worse. Now Bill is thinking, "Wow, even WITH treatment my depression is getting worse. This is hopeless." On the other hand, if Bill is warned, he may think "OK, this drug is not helping -- it might be making me feel worse. Maybe I should call my doctor and see what's happening here." Which line of thinking do you think is more apt to induce suicide?

If you've read my site with any regularity, you know what is coming next... We could sidestep the issue of suicidality, sexual side effects, and the like entirely. We could even have better long term treatment outcomes. It's called psychotherapy instead of medication for depression. Some patients might consider trying it out...

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