Do Antidepressants Increase Suicidality? Does The Black Box Warning Help or Hurt People? – Bipolar Burble Blog

Because of the black box warnings (also known as boxed warnings) of antidepressants, many people think that antidepressants cause suicidal thoughts, suicidal behavior, and suicide. The black box warning on antidepressants is, after all, the strongest warning the Food and Drug Administration (FDA) can place on a medication. However, the black box warning about antidepressants was written almost 20 years ago, and since then we have learned a lot and synthesized a lot of data. Does this more recent data indicate that antidepressants increase suicidality or cause suicides? What can we learn from this new information? Should we be afraid of the risk of suicide with antidepressants? (TL;DR here.)

What is the black box warning on antidepressants and how is it related to suicide?

As mentioned above, a black box warning is the strongest warning the FDA can place on a drug. Warnings themselves are common, but black box warnings are less so.

According to the Cleveland Clinic:

The U.S. Food and Drug Administration requires black box warnings, also called boxed warnings, for certain drugs that carry serious safety risks. Often, these warnings communicate possible rare but dangerous side effects, or may be used to communicate important instructions for safe use of the medication.

They appear printed in bold type surrounded by a black border on the insert that comes inside a drug package and on the drug manufacturer’s website, if it has one.

As an example, black. warning box for fluoxetine (Prozac) says:

In short-term studies, antidepressants increased the risk of suicidal thoughts and behaviors in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses.

This increase was not observed in patients >24 years; A slight decrease in suicidal thinking was observed in adults over 65 years of age.

In children and young adults, the risks versus benefits of taking antidepressants must be weighed.

Patients should be closely monitored for behavioral changes, clinical worsening, and suicidality; This should be done during the first 1-2 months of therapy and dose adjustments.

The patient’s family should report any abrupt changes in behavior to the healthcare provider.

Worsening behavior and suicidal tendencies that are not part of the present symptoms may require discontinuation of treatment.

As you can see, the boxed warning talks about suicide with antidepressants and other important prescribing information. Black box warnings are really for doctors, but patients usually also learn about them through medication brochures (the ones they hopefully receive at the pharmacy). Black box warnings tend to scare both doctors and patients.

Antidepressants and suicidal tendencies: latest data

The black box warning was placed on antidepressants in 2004. It made sense at the time. The FDA’s job is to be conservative about people’s safety. Attention should be paid to figures, even preliminary ones, when they show something as serious as suicide.

However, people are now questioning not only the appropriateness of the black box warning but also its benefits.

This is an excellent review. (2014) in Psychiatric Times about the risks of suicidal tendencies, suicidal actions, and suicide after starting an antidepressant. Conclusions include the following:

• Analysis of data from the FDA’s Adverse Event Reporting System (MedWatch; where adverse events are reported after the drug is on the market) from 1998 to 2004 showed that, as a class, selective reuptake inhibitors serotonin reuptake inhibitors (SNRIs) had a lower suicide rate than tricyclic antidepressants (TCAs). (Note that TCAs are an older class of antidepressants that are no longer commonly used.)
• In some cases, higher rates of TCA prescription are actually associated with higher rates of suicide. This may be due to the toxicity of TCA drugs, making them more deadly in the case of a suicide attempt.
• An increase in antidepressant use has been shown to correlate with a decrease in suicide rates over time worldwide. For example, in Sweden, a doubling of SSRI prescriptions was correlated with a 25% decrease in the incidence of suicide.
• US county-level data on suicide rates and antidepressant prescription rates were analyzed between 1996 and 1998. After adjusting for sex, race, age, income, and county-level unobservable effects, the analyzes revealed that increases in SSRI and SNRI prescriptions were associated with decreases in suicide rates both between and within counties over time.
• A cohort study of 226,866 veterans with newly diagnosed depression indicated that the rate of suicide attempts was lower in those treated with an SSRI than in those who did not receive an antidepressant.

What about suicide in youth?

Data on suicidal thoughts and actions in young people are less conclusive. Some data show that there is no increased risk of suicide in young people treated with antidepressants; Other data show that there may be a small increase in risk for those under 18 years of age (not 24). However, the risk is lower than previously thought. It appears that suicidal thoughts and actions are driven by factors other than depression in youth. (The idea is that antidepressants relieve depression in young people, but that’s not what drives their suicidal behavior.)

Even worse, This 2020 study found increases in suicide deaths among youth following black box warnings and decreased attention to depression.

After the black box warning, did suicides increase?

Unfortunately, the initiation of the black box warning on antidepressants may have increased suicides as professionals chose to use fewer antidepressants. Furthermore, among young people, less depression was diagnosed after the black box warning, suggesting that doctors were not only less willing to prescribe antidepressants, but were less willing to even make a diagnosis, which is unfortunate considering the other types of help that young people could receive. would have received if they had been diagnosed.

These reflectances may have been an error:

• Researchers looked at 845 suicides in the 10-19 age group in Sweden from 1992 to 2010. After the 2004 warning, the suicide rate increased for 5 consecutive years (60.5%), mainly in those who were not treated. with antidepressants. .

As the Psychiatric Times article says:

The FDA’s implementation of a black box warning was aimed at reducing suicide rates in children, adolescents, and young adults. The picture following the FDA warning and the implementation of the black box warning is not one of a lower suicide rate as the FDA intended or expected. Instead, we see fewer antidepressant prescriptions, an increase in youth suicides, and negative effects on human capital.

This report in Frontiers in psychiatry Describes the real-world damage that the black box warning can cause.

TL;DR: Do antidepressants increase suicides? Did the black box warning decrease suicide rates?

Simply put, it appears that antidepressants don’t actually increase the risk of suicide in adults. There may be a small risk for young people (even that is uncertain), but there are significant benefits to consider in that group. Furthermore, it appears that issuing such a stern warning about antidepressants actually had the unfortunate effect of increasing suicides, not decreasing them.

I’m not going to say what kind of warning the FDA should put on a drug. What I would say, however, is that our concern about suicides due to antidepressants was overblown. With incomplete information, we needed to do so at the time, but the same level of concern does not seem justified now, given the most up-to-date data we have. We should always, always maintain high supervision when a person starts taking any medication because we don’t know how they will react to it, but it is very unlikely that an antidepressant will actually cause suicide, and overreact to this possibility to the point of Denying the person. people an antidepressant or even a diagnosis is a mistake.

Note: I am not a doctor and each person’s individual risk profile varies. Always discuss all your concerns openly with your doctor.

Image by Nick Youngson through Pix4free.org.

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