FDA’s Black Box Warning On Anti-Depressants – Has It Done More Harm Than Good?

In 2004 the FDA issued a “Black Box” warning on anti-depressants indicating that these medications were associated with an increase in suicidal thinking, feelings and behaviors in young people.

Criticism

The FDA really had no choice but to issues the black box warning, as a 2004 review of 372 randomized controlled trials of anti-depressants identified a slight increase (4% as compared to 2%) in suicidal thinking and behavior among depressed adolescents and children who were prescribed anti-depressants. The increase was small but significant.

Ever since that black box warning was issued, however, there has been much criticism of the “Black Box” warning, as physicians feared it would deter patients from seeking help for depression, and would discourage doctors from prescribing necessary medication. Untreated depression is a risk factor for suicide

In response to the criticisms, in 2007 the FDA added language to the “Black Box” warning indicating that depression also increased the risk of suicide. The point of the expanded warning was to encourage physicians to weigh the benefits and risks of prescribing anti-depressants and not to withhold necessary treatment if it was indicated.

What has happened to anti-depressant prescribing rates?

We now have access to a large epidemiological study, which suggests that the primary effect of the FDA’s “Black Box” warning has been to discourage the use of anti-depressants. Even though the warning is only about adolescents and children, rates of anti-depressant use dropped in all age groups after the release of the “Black Box” warning in 2004 and continue to remain lower than expected even now.

There have been no increases in other types of treatment for depression, and there is no reason to believe that the actual rate of depression in any age group has dropped. The only logical conclusion is that since the “Black Box” warning came out, either physicians are more reluctant to prescribe anti-depressants or patients are more likely to refuse them.

Suicides?

Suicide rates across all age groups have gradually been increasing over time with no obvious sudden changes in or around 2004. However, a study of poisoning rates- using the poisoning rates as a proxy measure of the rate of suicide attempts- found a dramatic increase in rates of poisoning among both adolescents and young adults shortly after the “Black Box” warning was released in 2004.

Because all of the data about anti-depressants, suicide and depression rates are derived from observational studies, no direct causal link to the “Black Box” warning can be derived. However, the data are certainly suggestive. They seem to indicate that instead of saving lives, the warning has been harmful. Patients are not seeking treatment for depression. Doctors are not diagnosing and treating patients for depression. And patients are scared to take anti-depressants because of this black box warning.

The net effect is reduced quality of life and possibly an increase in loss of life due to suicides.

The “Black Box” warning almost certainly has made some patients believe that treatments for depression are ineffective or harmful. There are many reasons why doctors might be reluctant to prescribe anti-depressants with a “Black Box” warning on them.  A major reason is that if a depressed patient attempts suicide after being prescribed anti-depressants, the doctor is may be vulnerable to a malpractice lawsuit.

Should the FDA remove the “Black Box” warning on anti-depressants? In my opinion, the black box warning has been detrimental to the fight against depression. I’d love to hear your thoughts.