New FDA Warning on Antidepressants: What Does It Mean to the Depression Patient?

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New FDA Warning on Antidepressants: What Does It Mean to the Depression Patient?

THE NEW "BLACK BOX WARNING" ON ANTIDEPRESSANTS: WHAT DOES IT MEAN TO ME AS SOMEONE WITH DEPRESSION?

by Harry Croft, MD
Medical Director of HealthyPlace.com

On May 2, 2007 the FDA required a label change for antidepressant medications. This was the second time such a change had been required. The first was in 2004, when the FDA required that a black box warning (the most serious warning) appear on the package insert advising of a possible increase in suicidality in children and teens taking antidepressant drugs. The most recent action increased the age of those included from below 18 years to age 25.

As a clinician, I have already heard from many patients and family members worried about this recent change. Their concern basically is "what does this really mean to me or my loved one? Should we avoid taking the depression medicines, or stop them?" Before answering this concern, let me acquaint you with the background that led to the change.

WHAT IS A BLACK BOX WARNING, ANYWAY?

In the package insert sheets that come with a box of medication (which is usually thrown away by the pharmacist before you get the medicine), there are warnings about the use of the drug being prescribed. The strongest of these warnings is a "black box warning" (called such because of the bold black border around the wording). It is rarely read by patients, but news reports or patient brochures often mention the warnings. The "black box warning" for children and adolescents taking antidepressants can be found here. This FDA mandated wording warned of the possibility of increased suicidality and other symptoms which might be experienced by patients early in treatment with antidepressants. Beside suicidality, the following other symptoms might appear:

increase in anxiety or panic attacks
trouble sleeping
worsening anger-irritability or aggressive behavior
abnormal increase in activity or talkativeness, or "other unusual changes in behavior."

SO WHAT IS SUICIDALITY?

Suicidal refers to thinking of taking one's life, or actions towards this end. It is not the same as suicide itself. In fact in the 4400 children and adolescents studied in the clinical trials that led to this warning, there was not a single suicide. So, it was rather an expression of suicidal thinking or behaviors, rather than the actual taking of one's life, that was being referred to.

During the trials, in the group of children and adolescents on active antidepressant drug, there was a doubling of suicidality compared to those on placebo (sugar pills). That sounds ominous until one looks at the real numbers-4% on active drug vs. 2% on placebo. Increased to be sure, but not in actuality by a large number. That means in a group of 1000 kids taking the antidepressant drug, the number with suicidality is around 18. In the young adults aged 18-25 studies, it was an additional 5 cases of suicidality. No increase in suicides, but in suicidality. By the way, in adults over 25 there was no increase in suicidalty and in seniors age 65 and above, there was actually a decrease in suicidality.

continue with: The impact of the child/adolescent warnings

Harry Croft, MD is a practicing psychiatrist and medical researcher. He also conducts clinical trials on behalf of American pharmaceutical companies and is Medical Director of HealthyPlace.com.

Last updated 05/07

New FDA Warning on Antidepressants: What Does It Mean to the Depression Patient?

THE NEW "BLACK BOX WARNING" ON ANTIDEPRESSANTS: WHAT DOES IT MEAN TO ME AS SOMEONE WITH DEPRESSION?

WHAT IS A BLACK BOX WARNING, ANYWAY?

SO WHAT IS SUICIDALITY?

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