Antidepressants, Suicide Risk, and the FDA Black Box Warning

antidepressants and suicide risk: FDA black box warning

Do antidepressants increase the risk of suicide? There are certainly people out there who are very vocal in insisting that they do. However, as is so often the case, the loudmouths don’t tend to be especially well informed.

The FDA black box warning

Since 2004, the  U.S. Food and Drug Administration (FDA) has required a “black box label” (the most serious warning label they have) on antidepressants warning of an increased risk of suicidality in children and adolescents.

The FDA makes these types of decisions after considering the recommendations of its expert advisory committees. In the case of this particular warning, 8 out of 23 members of the advisory committee recommended against the black box warning.

This all came about after the FDA conducted a series of meta-analyses, which grouped together data from 372 clinical trials involving over 100,000 pediatric and adolescent participants. The number-crunching they did on all of the pooled data showed an increased risk of suicidality in participants receiving antidepressants compared to placebo. The rate of suicidal thinking was 4% in those that took antidepressants, and 2% in those that got a placebo; there were no suicide fatalities in those clinical trials. Various researchers have since raised concerns about the soundness of the FDA’s methodology in conducting the meta-analyses.

At the same time, FDA meta-analyses showed that there was no increase in suicidality associated with antidepressants for adults 24 years and older. Antidepressants had a clear protective effect for adults 65 years and older.

Aftermath of applying the warning label

Since the warning was put in place, there’s been a decrease in antidepressant prescribing for children and adolescents, but there’s also been a decrease in the rate of new depression diagnoses, and no increase in the use of other forms of treatment. If an unintended consequence of the black box labelling is that more people are going undiagnosed and untreated, that’s a problem.

While the FDA didn’t apply the warning to the use of antidepressants in adults, and there was no research to support doing so, sometimes people do erroneously extrapolate the information that way.

Akathisia, antidepressants, and suicide risk

There has been some media attention in recent years to antidepressants possibly increasing suicidality as a result of akathisia. Akathisia involves physical restlessness, which can be quite distressing. It’s more commonly associated with antipsychotic use, particularly older antipsychotic medication.

While akathisia is reasonably common as a side effect of antipsychotics, and several medication strategies have been identified to manage it if a change in antipsychotic isn’t the preferred option, akathisia as a result of antidepressants is rare. This difference likely results because antipsychotics directly affect D2 dopamine receptors, which can trigger akathisia, whereas the mechanism by which antidepressants can produce the same effect is more indirect.

A 2018 paper in the Oxford Journal of Neuropsychopharmacology found that among 219,635 hospitalized adult patients taking antidepressants, 83 patients had “suicidal adverse drug reactions”. Most of the reactions occurred shortly after starting or increasing the dose of an antidepressant. Restlessness was documented in 42 of these patients. There were 34 attempted and 5 completed suicides. Overall, the researchers concluded that suicidality as an adverse drug reaction is rare, and restlessness and impulsiveness could be considered early warning signs.

Other factors to consider

There’s another factor that could come into play with starting on antidepressants. It’s well-known that when depressed people with suicidal ideation start to respond to treatment and feel a little better, that’s a high-risk time. Often energy starts to improve before mood does, so if someone has recently started medication, their mood could still be very low, but they may have regained enough energy and motivation that they’re more likely to follow through on suicidal thoughts.

The biggest issue, though, is the risk of suicide due to untreated depression. Even if antidepressant-related akathisia is a risk, you can’t compare that to a presumed baseline risk of zero for someone not taking antidepressants. People with depression who don’t get treatment are at serious risk of dying, and antidepressants are more effective than placebo at treating depression.

Am I suggesting that medications are the right choice for every person all of the time? Absolutely not.  Decisions regarding any form of treatment for any health condition should always be based on an individual weighing of pros and cons. Making decisions about one’s health based on misinformation and assumptions, though, is not doing anyone any good.

I think what’s far more useful than vilifying antidepressants is ensuring adequate and responsive follow-up for anyone starting on medications. That’s an onus on the health care system, but as patients, we also have a responsibility to communicate significant reactions to our health care providers.

Depriving people of treatment, though, isn’t the answer to anything.


  1. Do antidepressants increase the risk of suicide in children & youth?

    Possibly. The FDA chose to add a black box warning after pooling some data that suggested an increase in suicidal ideation (but not actual suicide) in children and youth.

  2. Do antidepressants increase the risk of suicide in adults?

    There's no evidence of that.

  3. Do the risks of antidepressants outweigh the benefits?

    That will always need to be an individual decision, but it's important to consider that untreated depression is a major risk factor for suicide. Whatever risks antidepressants might have, the alternative does not carry zero risk—not even close.


book cover: Psych Meds Made Simple by Ashley L. Peterson

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Ashley L. Peterson


Ashley is a former mental health nurse and pharmacist and the author of four books.

25 thoughts on “Antidepressants, Suicide Risk, and the FDA Black Box Warning”

  1. Sometimes I do wonder ‘does anybody knows what they are doing?’ People and media are so quick to call: that’s good, that’s bad! I think we need to take a deep breath, look at the situation from a distance and more than not we’ll see that things are good as they are but they need fine tuning and we need to progress without starting all over. Lets work with the medication we have and try to apply them the best way we know so they can help the person. Not yell: everything is bad’ but to look when what needs to be applied with caution and care.

  2. A good post you have highlighted here. Certainly one to mention.
    It’s like any medication, there are pros abd cons, it’s finding what benefits the person. I think as long as someone on antidepressants is monitored and making sure they are monitored, is the best tning you can do. Openness between patient and doctor and the right treatment can hopefully be given.

  3. My heck. Now it occurred to me that if adolescents and children are at a higher risk of suicide allegedly because they take anti-depressants, wasn’t the overall depression the cause, not the drug? Children and adolescents are still learning about their emotions and how to handle them and depression is perhaps especially harsh because they already sort of see things as black and white anyway. I’ve taken Zoloft for quite a few years now and I see a benefit. When I don’t take it (skip a day or am unable to take it because I didn’t think to take it on a trip or something), I notice my mood worsens a lot. For me it’s been a life saver. Other anti-depressants I’ve tried have not worked very well, some made me irritable, some made me hyper, some made me sleep more. If one is uninformed about a subject, it’s generally always best (IMO) to keep one’s mouth firmly closed. Thanks for the education! 🙂

  4. Medication did make me more depressed when I got older. This is what made me stop wanting to go back to taking them. From my experience, doctors always recommend keeping in touch to make sure what your taking is right for you and working.

    I thought it was the other side affects that could be a factor for suicide. Like feeling not yourself, weight gain, anxiety and things like that.

  5. I think my first episode of depression, aged sixteen, went undiagnosed because the doctor didn’t want to prescribe antidepressants, so said I was “emotionally low,” whatever that means. This was before the study you mention here though (it would have been in 1999).

  6. Anti-depressants make me more depressed because they cause me to gain weight and I have an eating disorder. So, I will not take them. Anyway, what makes me the most depressed is dating, and I’ve quit doing that. I charged myself a hefty fee for that diagnosis too! 😂

  7. It’s really nice to learn more about this – as I have seen the many headlines in the newspaper that cover it. I was always curious what exactly made it more risky, especially for younger patients. It’s nice to get a more thorough background on the why of it all.

  8. I think like with all medical interventions it’s a questions of trade-offs: Does the severity of a problem justify the treatment in awareness of possible iatrogenesis or are there less risky options available. If the possible benefits from using medication is greater than its adverse effects – go for it. Otherwise one might consider alternative ways.

  9. I think the vast majority of them are completely fucking useless and the side effects can be terrible. I’ve not found any that work and I have given up with them.

  10. We were in the hospital recently and a neuro-psychologist taught the group of patients (mix of PTSD, Major Depression, and Borderline Personality patients) that SSRIs and calming meds (ie Xanax) cure nothing by themselves. They may help coping while therapy (namely, CBT) rewires the brain, ostensibly by weakening pathway between amygdala and hind parts and strengthening pathway between amygdala and cortices.

    This was a shocking reminder that we started meds in order to lessen symptoms so that we could make progress in therapy. We are used to anti-biotics that cure an illness.

    Then we went two days forgetting to take our SSRI and had headache, body pain, and many uncomfortable symptoms.

    We’ve been on and off SSRIs during past 4 years for OCD with no perceived benefit to us. And the weaning off caused dangerously high SI in one instance.

    These experiences led us to wean off our latest SSRI that was not helping perceptibly. On our own. Slowly. We should have done it supervised. This is our arrogance with our experience and distaste for health care and psychiatric treatment.

    We think the neuro-psychiatrist should have been more careful with his comments. We were sad that the medicine isn’t a “cure.” He made it seem like it’s not even recommended for years-long use. We think Xanax keeps us safe from suicide. We will keep using as prescribed.

    Our PTSD may never resolve. Our dissociation may never fully abate. So we feel ashamed that after 5 years of therapy, we’re still disabled. There’s a lot to what we think medication can do vas what it really does. Sorry so long!

    1. Regardless of what any medication should or should not do, you know yourselves best and what keeps you safe. To me it doesn’t seem very responsible for a mental health care provider to be talking about whether things cure illness. Some people have their illness go into remission, but many people don’t, so talking about any kind of cure seems like it would just set up false expectations.

      1. We also felt very far from healing when we learned that listening for danger most nights of our childhood had strengthened our hypervigilance response. Undoing a neuropathway that is decades old—and building a new one—can only take more time.

        That’s okay. We will try to do the practice of mindfulness, of meditating, noticing feelings/sensations and the impermanent nature of these responses. Hopefully our startle response will also prove impermanent.

        You are very kind to blog about topics that can help people, so thank you for that and for replying to our comment💕

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