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Antidepressants Black-Box Warning

Written by Dr. Sireesha Kolli

When it comes to treating depression, especially in children, adolescents, and young adults, it’s crucial to understand the risks and benefits. One major concern is the risk of suicidal thoughts and behaviors. Let’s look at how this risk compares between those taking antidepressants and those left untreated.

Risk of Suicidal Thoughts and Behaviors with Antidepressant Use

SSRIs, which include common medications such as Prozac, Zoloft, Lexapro, Celexa, and Paxil, are frequently prescribed to treat depression, anxiety, and other mental health conditions. While these medications can be very effective, it’s crucial to understand the “black box warning” that comes with them.


Black Box Warning

Children, Adolescents, and Young Adults– Antidepressants can increase the risk of suicidal thinking and behavior (suicidality) during the initial treatment period, usually the first few months. Studies show a 2-4% increase in risk compared to placebo.

Lack of Increased Risk in Adults (25-64 years): Studies, including those reviewed by the FDA, indicate that there is no increased risk of suicidality in adults over 24 years of age.

Decreased Risk in Older Adults (65 years and older): There is a decrease in the risk of suicidality among older adults taking antidepressants, suggesting a protective effect in this age group.


Important Considerations for Antidepressants


Initial Treatment Phase:

Early Weeks: The initial few weeks to the first couple of months of treatment are particularly important. During this time, close monitoring can help identify any changes in mood or behavior early on.

Dose Adjustments:

Elevated Risk: The risk can also be elevated during periods of dose changes, either increases or decreases. Close monitoring during these times is essential.


Regular check-ins with the person taking the medication can help identify these changes early. Keeping a journal to track mood, behavior, and physical symptoms can be useful for noticing patterns and addressing issues promptly. It’s essential to communicate any concerns with healthcare providers, as they can provide guidance and adjust the treatment plan as necessary.

Signs to Watch For:

When starting an antidepressant like Prozac, it’s important to be vigilant for any changes in mood or behavior, particularly in children, adolescents, and young adults. Emotional changes such as increased anxiety, agitation, irritability, or panic attacks should be closely monitored.

 Behavioral changes like hostility, impulsivity, and restlessness can also be significant indicators that need attention. Additionally, sleep disturbances, including insomnia or excessive sleeping, and mood swings, such as hypomania or mania, where there is an unusually high level of energy and decreased need for sleep, can occur.

One of the most critical signs to watch for is new or worsening thoughts of self-harm or suicidal ideation, where the person may express thoughts about suicide, make plans, or take steps towards attempting suicide.

Immediate Action:

Seek Help: If any of these symptoms or other concerning behaviors emerge, it is important to contact a healthcare provider immediately.


Weighing Risks and Benefits


Clinical Judgment: Psychiatrists must balance the risks of antidepressant treatment with the clinical need. For many patients, the benefits of managing depression or anxiety outweigh the risks of potential side effects.

Informed Decisions: Patients and their families should be involved in the decision-making process regarding the use of antidepressants, understanding both the potential risks and benefits.


Key Findings from Research


Risk with Antidepressants:

      • Increased Risk in Young People: Studies show that antidepressants can increase the risk of suicidal thoughts and behaviors by about 2-4% in young people (under 24 years old). This increase is mainly observed during the first few months of treatment.
      • Research: A meta-analysis published in JAMA found this increased risk but also highlighted the importance of monitoring and appropriate clinical management to mitigate these risks.

Risk with Untreated Depression:

      • Higher Suicide Risk: Untreated depression itself is a major risk factor for suicide. People with untreated depression have a significantly higher risk of suicide compared to those receiving treatment.
      • Research: Research published in the Archives of General Psychiatry showed that while antidepressants slightly increase the risk of suicidal thoughts in young people, untreated depression carries a much higher risk of severe outcomes, including suicide.

Impact of FDA Warnings:

  • Balanced View Needed: After the FDA issued black box warnings about the risk of suicidal thoughts with antidepressants, some studies found that fewer prescriptions were written, but this led to concerns about higher suicide rates due to untreated depression.
  • Research: An article in the American Journal of Psychiatry discussed this delicate balance, emphasizing the importance of not leaving depression untreated while also being mindful of the risks associated with medication.


Parental Advice


Benefits of Taking Antidepressants

  • Effective Symptom Management: Antidepressants can significantly reduce the symptoms of depression, helping improve mood, energy levels, and daily functioning.
  • Reduced Overall Suicide Risk: By alleviating severe symptoms of depression, antidepressants can lower the overall risk of suicide.


Risks of Leaving Depression Untreated

  • Increased Suicide Risk: Without treatment, depression can worsen, leading to a higher risk of suicidal thoughts and behaviors.
  • Impact on Quality of Life: Untreated depression can severely affect one’s ability to work, maintain relationships, and enjoy life.



While antidepressants do carry a risk of increased suicidal thoughts, especially in younger patients, the risks of untreated depression are often greater. Effective treatment, combined with careful monitoring and open communication with healthcare providers, can help manage these risks. Always discuss any concerns with your doctor to make the best decision for your health.

For an in-depth understanding of Prozac, we have compiled a comprehensive article on Prozac, covering everything from dosage to side effects. You can read it here

Moreover, many of our patients and caregivers have numerous questions about starting Prozac, including its uses, side effects, and how it works. To provide detailed answers to the most common queries, we’ve compiled an extensive Frequently Asked Questions about Prozac guide. This resource aims to help you make informed decisions and manage your treatment effectively.



  1. Bridge, J. A., Iyengar, S., Salary, C. B., Barbe, R. P., Birmaher, B., Pincus, H. A., & Brent, D. A. (2007). Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: A meta-analysis of randomized controlled trials. JAMA, 297(15), 1683-1696.
  2. Hammad, T. A., Laughren, T., & Racoosin, J. (2006). Suicidality in pediatric patients treated with antidepressant drugs. Archives of General Psychiatry, 63(3), 332-339.
  3. Gibbons, R. D., Brown, C. H., Hur, K., Marcus, S. M., Bhaumik, D. K., Erkens, J. A., Herings, R. M., & Mann, J. J. (2007). Early evidence on the effects of regulators’ suicidality warnings on SSRI prescriptions and suicide in children and adolescents. American Journal of Psychiatry, 164(9), 1356-1363.
  4. FDA Analysis of Suicidality in Pediatric Trials of Antidepressant Medications. 2-339.

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