FDA Set to Add to Antidepressant Warnings, Allow Emotion to Sway Policy
> 12/14/2006 10:26:19 AM

It seems all but a certainty that the FDA will proceed forward with its plan to add to the existing black box warning on SSRI class antidepressants. After hearing testimony and deliberating yesterday, the FDA's advisory panel recommended that the current warnings be expanded to include warnings of increased suicidality among those receiving antidepressants up to the age of 24. The panel's recommendation follows a meta-analysis of 372 studies that incorporated 11 drugs and over 100,000 participants and found that suicidal ideation and behavior increased in young adults up to 24 years of age.

News reports from yesterday's hearings play up this research, but we've had trouble locating it anywhere on the FDA's website, and even if we could find it, there's little doubt that it would do nothing to change our previous criticism of these black box warnings. In fact, independent research (study not conducted within the FDA) has found an inverse relationship between antidepressant prescriptions and suicide. Depression treatment with antidepressants cuts suicide risks, that is a fact evidenced by another study that was published in November's edition of the American Journal of Psychiatry. As Dr. Gregory Simon points out in a definitive editorial from the same publication, the basic breakdown of this debate is that there is evidence that for some children (and now apparently young adults) beginning antidepressant treatment triggers something that increases suicidality. At the same time, research has shown that increases in antidepressant treatment corresponds directly with less suicide, even within the groups that have reported the increased suicidality.

What has happened here is that two disctinct camps have developed and created a black vs. white or good vs. evil situation. On one side are psychiatrists and doctors who have decried the initial black box warnings, and continue to fight any increases in warnings. This group is led primarily by the American Psychiatric Association, and has pushed the argument to which we adhere, that increased warnings lead to greater apprehension on the part of patients who would benefit from SSRI prescription. This decrease, and its resultant increase in depression and suicide, would easily outpace the increased suicides that have been blamed on starting antidepressant treatment. Even those advocating new warnings admit that the number of those affected by this potential side-effect is very small, and that increased warnings deter those in need from seeking help. In their minds however, the risk that anyone might experience an increase in suicidality is unacceptable, and requires the strongest possible warning.

It is here that one can find the greatest flaw in yesterday's proceedings. While doctors and those associated with the APA testified against the increases in warnings, the other side was in large part represented by individuals who had lost family members to the supposed link between SSRIs and suicidality. As the AP reported, grieving relatives marched in front of the advisory committee and using slides of dead family members, accused the FDA of literally killing people because of their inaction. With all due respect to those who have died, this type of action is unacceptable. In weighing risks versus rewards, there needs to be some level of objectivity. How does the panel benefit from seeing pictures of a dead man with his grieving wife pointing fingers? Should the APA have paraded the millions of individuals whose lives have been saved by antidepressants in front of the panel?

We don't mean to make it seem as if there aren't those doctors and psychiatrists that support the increased warnings, because there are. But in reality, these care providers are misguided. Dr. Joseph Glenmullen, author of "Prozac Backlash," defended this position by saying that the increased warnings would help patients make "informed decisions." Clearly though warnings are not the only way to ensure that patients understand the options involved in their treatment. Education about the rewards and potential risks and side-effects is standard for any medication, and any prescribing physician who fails to thoroughly discuss these with their clients is being delinquent in their duties.

This is not a black and white issue. It is clear however, that the warnings are the wrong way to go. Warnings have drastically effected the rates of prescription for antidepressants, and while the information is still coming in, what will we do if we find that the initial black box warnings led to an overall increase in suicide rates? We can achieve the actual desired effect of the warning--i.e. ensuring safety and improving outcomes--by making sure that these drugs aren't just prescribed willy-nilly by general practitioners who don't have the time or ability to provide the necessary monitoring and followup therapy. The NIMH is funding a slew of new studies that will delve further into the relationship between antidepressants and suicide, but unless new research provides resounding and unassailable proof that antidepressants cause increased suicidal behavior and thought, we need to actually air on the side of caution and make sure that those who truly need these drugs are not dissuaded from seeking the help that could save their lives.

Read our earlier discussion of this contentious topic here and here.

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