Did Antidepressant Black Box Warnings Increase Suicides?
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.
Tracy, N. (2015, May 20). Did Antidepressant Black Box Warnings Increase Suicides?, HealthyPlace. Retrieved on 2022, August 15 from https://www.healthyplace.com/blogs/breakingbipolar/2015/05/did-antidepressant-black-box-warnings-increase-suicides
Author: Natasha Tracy
Well, I was one of the gineau pigs for the black box warning. My psychiatrist prescribed zoloft for depression when I was 20. I went from being depressed to feeling like I was living in the twilight zone and couldn't function at all. My doctor kept telling me that it takes time for the medication to work, keep taking them. Well, after a couple of months, I couldn't take the torment any longer. I Really believed it was due to my "broken brain", but what do you know? 5 years after my massive and very painful/traumatizing suicide attempt, l find out it was the drug. Well, glad lives are now being saved with the warning. Too bad for all the lives that were lost before 2004. Makes me wonder about future black box labels. I think the general public should really educate themselves and be very careful when starting, or withdrawing from any medication. Unfortunately, prescribing doctors only know so much about the potential side effects.
The correlation between antidepressant therapy and suicide is most intrigued issue on current psychiatric treatment of depression, as common mood disorder. There are a lot of clinical investigation that confirm the data that desinhibitor antidepressant such are so called noradrenalin re uptake inhibitors could be dangerous for suicide implications. But these kind of investigation are more based on statistical and theoretical data than in others bio-psycho-social features of patient with depression. Furthermore, these numerous clinical psychiatric researches are often contestant and unreliable, as well. However, it is well known fact that there are many patient whose antidepressant therapy end with suicide, especially after decline of first first attack of depressive phenomenology. I think that the best way to avoid suicidal consequences of antidepressant therapy is multi axial approaching along psychiatric treatment of respective patient with depression. To achieve this promising goal, it should to explain all aspect of global life functioning to patient who is in antidepressant medication: age, sex, profession, commorbid status, social and economic features and so on. This complex treatment of depression is in accordance with last one recommendation of multidimensional aspect of real nature of humane beings. Without this mindful remark antidepressant therapy would be insufficient and with many complications, among them suicide, as most worst outcome.
I am one of the reasons there is a black-box on Paxil. Thankfully, I'm alive to share that with you. Many young men from the early 90's didn't live through their experience with Paxil, and I consider myself lucky not to be one of them.
Back in 1994, at age 22 I went on Paxil. Within 5 months of starting Paxil, I nearly died by suicide, was in ICU for 4 days and on the ward for two weeks afterward. It took me a year to recover.
There's a lot more to the story, the direct cause and effect with Paxil, and the reporting of my case and cases like mine than can be adequately covered in a blog comment.
I wish there had been a black box on Paxil in 1994. Then perhaps my doctor would have prescribed it to me more carefully, watched me more closely, and would have potentially save my family and me immense pain and suffering.
Thanks for all your great work, Natasha and thank you for reading my comment. Have a nice day.
Interesting thought. It is the law of unintended consequences. Before safety caps for med bottles, people were safe where they left them. With safety caps people over estimated their abilities and left them lying around. Soon enough kids figured them out and overdoses by kids exceeded before safety caps.
I agree with Rose
Better off using coffee than antidepressants anyway. Coffee is usually cheaper, you don't need a prescription to get, it's all natural, it increases mental alertness, increases energy, helps with weigbt loss, lessens depression and has anti-oxidant properties. I've never heard of anyone saying that coffee has increased suicidal ideation/suicide in anyone before. Have you?
Shouldn't we be figuring out WHY antidepressants cause an increase in suicidal thoughts/ideation rather than promote the taking of them first.
Well, as I said, I don't think they really do, overall. That said, I can tell you the current theory (which I happen to believe). Basically, antidepressants increase energy in people, sometimes before mood improvement, and in those who are suicidal, this can give them the energy to complete the action they have been wanting all along. It's not about the antidepressant as much as it is the person. Also, sometimes before mood improvement there may also be psychomotor agitation and this could, again, make a person complete a suicide when they couldn't before due to their extreme lack of energy and motivation because of the depression.
- Natasha Tracy