Black Box Warnings — Read Carefully!


As far as I know, every antidepressant has the same “black box” warning on its package insert, as reported by a reputable academic psychiatrist in a reputable journal a while ago.

Incidentally, he has, in this editorial type piece, effectively logged most of the “attacks” recently made upon psychotropics.  He advises the readers, presumably other psychiatrists or at least physicians of some sort, to do “nothing.”  This is the common way of academics, to wait and gather data.  It is not a common way of doctors, at least ethical or idealistic ones, who still scramble at any chance to save people.

black-box warning

For now let’s look at the warnings about antidepressants that have merited the special FDA attention. Except that it is in a “black box”  (has a black border like a funeral announcement) and there may be a couple of things added on relative to an individual brand, this is the disclaimer: WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders.

Anyone considering the use of (Brand Name) or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

They did it again!  They have effectively deflected the liability, the advantages and risks questions about antidepressants, and dumped all of the liability on (ta da) the doctor.  The drug companies, who love package inserts and are constantly changing them, have managed once again to dump absolutely all of the risk on the doctor. I know I said it twice, but it so perfect.  Not even a chess game. The corporation (read, “drug company”) wins.

The same medication can either CAUSE an adolescent or young adult to commit suicide or help them NOT commit suicide. There are plenty of delightful terms in package inserts but they all have the same basis.  Make the doctor be very sure that he or she takes it all on their shoulders. The original FDA warning has generally been criticized for being unusually broad, maybe even unnecessary, given the amount and type of data available when it was made.

Are they really that dangerous??

Americans love to think about things in political ways.  Now it is true that there is relatively little data that shows that antidepressants prevent suicide.  But frankly, I think the author of this article, who is actually a bit radical anti-prescription medication, is playing a little fast and loose. I do not think that the high suicide rate in the military is ONLY because of prescription antidepressants. When Harry S. Truman, one of my idols, said “war is hell,” he did not know all the extenuating circumstances of our current situation. There are other reasons to commit suicide during wartime, although handing out truckloads of antidepressants is not necessarily the optimum endpoint of military psychiatry.

The question is how you TELL if somebody is going to be pushed toward suicide or saved from it by this exciting set of medications that a tremendous amount of the population takes — Enough to find them in the water supply.

First thing to do is to read the package insert.  My spies tell me about a colleague who in a staff meeting was asked by a lowly staff member (formerly a patient) why he did not take some time to read package inserts, as she did –and seemed to know things that he didn’t. So, antidepressants can go either way.

In clinics for indigents, I have prescribed them when they are all that is available.  But I do not think they are necessary for all depressions, and there are plenty of other ways to treat a depression. There are therapies, both natural substances, talk related, and alternative, that work fine.

People have a right to decline antidepressants. “Whatever you suggest” is always answered by “They go in your mouth, sweetie, and you gotta sign the informed consent.”

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