On May 2, 2007, the Food and Drug Administration (FDA) ordered that all antidepressant medications carry an expanded black-box warning incorporating information about an increased risk of suicidal symptoms in young adults 18 to 24 years of age. The so-called “black-box warning” appears as one of the first things listed on a medication’s insert — you know, that tiny piece of paper that has something like 10,000 words on it that virtually nobody reads.
So such warnings are perceived as doing more harm than good, because they scare people away from effective treatments. But it’s probably not the warnings themselves that scare people away from treatment, since few people take the time to read those book-length inserts — adding more words to an already-bloated piece of paper that’s supposed to inform and help people understand their medication really won’t make much difference. (Assumedly, too, that if the person was already prescribed and has the antidepressant medication, they wouldn’t be amongst the datapoints that show prescriptions drop off after the warnings are added.)
Instead, it appears the publicity, press releases, shallow news coverage, and ten-second-formed opinions are what are more likely to change a person’s perceptions about an effective treatment option, such as antidepressant medications.
But yesterday, Richard Friedman, M.D. and Andrew Leon, Ph.D., published an editorial in The New England Journal of Medicine which analyzes the FDA’s decisions making process for this latest warning, with some insightful commentary about what drives such warnings to be made in the first place and its likely effects:
The new black-box warning is clearly an attempt to balance the small risk posed by antidepressants against their well-documented benefits. But this new label has the potential to confuse both patients and physicians. After all, if depression and other psychiatric illnesses are “associated with increases in the risk of suicide,” as the warning states, and antidepressants are known to be effective treatments for such disorders, why not just state the obvious: that untreated depression and psychiatric illness carry a significant risk? Because such a statement would too closely resemble a treatment recommendation, which is outside the purview of the FDA.
Their point, and it’s a good one lost on the media coverage when the FDA announced its decision a month ago, is that untreated depression is far more serious a risk for suicide than taking an antidepressant medication:
There may be controversy about the risk posed by antidepressants, but there is none about the risk associated with untreated depression: estimates of the lifetime risk of suicide in depressed persons range from 2.2 to 15%, depending on the population under study — not to mention the considerable suffering and functional impairment caused by this illness. In contrast, the FDA meta-analyses reveal an absolute risk of suicide in patients taking investigational antidepressants of 0.01%.
And since nobody seems to actually publish what is on this “black-box warning,” here’s the FDA sample of what it should look like on the package insert:
Antidepressants are an important part of a balanced treatment approach to depression, a serious and real mental health concern. Untreated depression is far more likely to result in someone’s suicide than someone who takes an antidepressant.
Reference: Friedman, R.A. & Leon, A.C. (2007). NEJM — Expanding the Black Box — Depression, Antidepressants, and the Risk of Suicide. New England Journal of Medicine, 356:2343-2346.