David Baxter PhD
Late Founder
Did Antidepressant Black Box Warnings Increase Suicides?
by Natasha Tracy, HealthyPlace
May 20, 2015
The antidepressant black box warning was issued to reduce suicide in youth but has the antidepressant black box warning actually increased suicides?
In 2004, the Food and Drug Administration (FDA) issued a black box warning (the most serious type of warning) on antidepressants advising of the risk of suicide in children taking antidepressants. In 2006, the FDA expanded this warning to include youth under the age of 24. The goal of these black box warnings was to reduce suicides in these populations. Unfortunately, the antidepressant black box warnings appear to have had unintended consequences. The antidepressant black box warnings appear to have actually increased the rate of suicide.
Why Was the Antidepressant Black Box Warning Issued?
Black box warnings are the FDA?s way of giving doctors critical information about a drug when the effects of that drug can be life-threatening. In the case of antidepressants, it was originally alleged in 2004 that antidepressants (specifically, selective-serotonin reuptake inhibitors (SSRIs)) could increase the risk of suicide in children under the age of 18.
At the time, there was conflicting data about whether this really was the case. One analysis showed it was while one analysis showed it wasn?t. The FDA, however, chose to act cautiously and issue a black box warning even with conflicting and insufficient data.
In 2006, another analysis was done by the FDA and it showed no increased risk of suicide with antidepressant treatment. However, when age was taking into consideration, the age group 18-24 appeared to have an increased risk that approached significance. (This means that statistically it wasn?t significant but it was close.) Based on this, the FDA altered the black box warning to warn of increased suicidal behavior and suicidality in youth (under the age of 25) as well as children.
New Data on Antidepressants and Suicide
Since then, many, many analyses have been done and while there is conflicting data in some areas, what is clear is that: in adults (over the age of 18) the risk of suicide on antidepressants is far less than for those not treated. In adults, this statement is significant and in the elderly this effect is even more pronounced.
In children, it?s a little more complicated. The data shows that the suicide rate can be the same in those on antidepressants and those not. I suspect this is because:
Did the Antidepressant Black Box Warning Increase Suicides?
While the FDA made the cautious decision, and we all want them to protect our health in the best way possible, the black box warning on antidepressants may have been a mistake. I believe the antidepressant black box warning has actually increased suicide and suicidal behavior in people.
In study after study four things have become clear:
What Should Be Done about the Black Box Warning on Antidepressants and Suicide?
I?m not a doctor so these things really aren?t up to me, but if I were the FDA I would:
And I would also make very clear the steps that need to be taken to avoid suicide in those taking antidepressants. Namely, much better monitoring over the initial period of prescription and talking to the patient about the possibility and what to look for that may put them at a greater risk. (The people primarily at risk of suicidal behavior and action, by the way, are people with bipolar depression being inappropriately treated with monotherapy antidepressants and nowhere does any black box warning take this into consideration. See this study from 2013.)
Look, I?m not for children or grandparents or anyone being prescribed more antidepressants. Antidepressants should be used only in the right cases and for the right people, but what I am for is accurate information so that doctors have the tools to determine who the right patients are. Right now the public, and doctors, are acting out of antidepressant black box warning fear instead of what studies support to be the truth.
For all the details and references for the above information, please see Psychiatric Times article, The Relationship Between Antidepressant Initiation and Suicide Risk.
by Natasha Tracy, HealthyPlace
May 20, 2015
The antidepressant black box warning was issued to reduce suicide in youth but has the antidepressant black box warning actually increased suicides?
In 2004, the Food and Drug Administration (FDA) issued a black box warning (the most serious type of warning) on antidepressants advising of the risk of suicide in children taking antidepressants. In 2006, the FDA expanded this warning to include youth under the age of 24. The goal of these black box warnings was to reduce suicides in these populations. Unfortunately, the antidepressant black box warnings appear to have had unintended consequences. The antidepressant black box warnings appear to have actually increased the rate of suicide.
Why Was the Antidepressant Black Box Warning Issued?
Black box warnings are the FDA?s way of giving doctors critical information about a drug when the effects of that drug can be life-threatening. In the case of antidepressants, it was originally alleged in 2004 that antidepressants (specifically, selective-serotonin reuptake inhibitors (SSRIs)) could increase the risk of suicide in children under the age of 18.
At the time, there was conflicting data about whether this really was the case. One analysis showed it was while one analysis showed it wasn?t. The FDA, however, chose to act cautiously and issue a black box warning even with conflicting and insufficient data.
In 2006, another analysis was done by the FDA and it showed no increased risk of suicide with antidepressant treatment. However, when age was taking into consideration, the age group 18-24 appeared to have an increased risk that approached significance. (This means that statistically it wasn?t significant but it was close.) Based on this, the FDA altered the black box warning to warn of increased suicidal behavior and suicidality in youth (under the age of 25) as well as children.
New Data on Antidepressants and Suicide
Since then, many, many analyses have been done and while there is conflicting data in some areas, what is clear is that: in adults (over the age of 18) the risk of suicide on antidepressants is far less than for those not treated. In adults, this statement is significant and in the elderly this effect is even more pronounced.
In children, it?s a little more complicated. The data shows that the suicide rate can be the same in those on antidepressants and those not. I suspect this is because:
- Children behave irrationally and impulsively ? far more than adults.
- Children are subject to lifestyle factors like bullying and abuse that are not solved by the prescribing of antidepressants and these may greatly impact the decision to attempt suicide.
Did the Antidepressant Black Box Warning Increase Suicides?
While the FDA made the cautious decision, and we all want them to protect our health in the best way possible, the black box warning on antidepressants may have been a mistake. I believe the antidepressant black box warning has actually increased suicide and suicidal behavior in people.
In study after study four things have become clear:
- Fewer children are diagnosed with depression than previously ? meaning that fewer children are getting any kind of help for their mental illness.
- Antidepressant prescriptions have declined.
- The decline in antidepressant prescriptions is linked to an increase in suicides.
- The risks of treatment with antidepressants are vastly less than the risk of suicide with no treatment.
What Should Be Done about the Black Box Warning on Antidepressants and Suicide?
I?m not a doctor so these things really aren?t up to me, but if I were the FDA I would:
- Clarify the black box warning based on current data.
- Make sure people understand the risk of not treating depression is much greater than the risk of treating.
And I would also make very clear the steps that need to be taken to avoid suicide in those taking antidepressants. Namely, much better monitoring over the initial period of prescription and talking to the patient about the possibility and what to look for that may put them at a greater risk. (The people primarily at risk of suicidal behavior and action, by the way, are people with bipolar depression being inappropriately treated with monotherapy antidepressants and nowhere does any black box warning take this into consideration. See this study from 2013.)
Look, I?m not for children or grandparents or anyone being prescribed more antidepressants. Antidepressants should be used only in the right cases and for the right people, but what I am for is accurate information so that doctors have the tools to determine who the right patients are. Right now the public, and doctors, are acting out of antidepressant black box warning fear instead of what studies support to be the truth.
For all the details and references for the above information, please see Psychiatric Times article, The Relationship Between Antidepressant Initiation and Suicide Risk.
