What are precautions in the use of medications to treat persistent depressive disorder (dysthymia) in children and adolescents?

Updated: Oct 01, 2019
  • Author: Jerry L Halverson, MD; Chief Editor: David Bienenfeld, MD  more...
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Answer

Physicians should be aware of the US Food and Drug Administration (FDA) black box warning regarding antidepressant treatment in children and younger adults and use appropriate caution when considering the risks and benefits of antidepressant treatment in these populations.

In December 2003, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued an advisory that most SSRIs are not suitable for use by persons younger than 18 years for treatment of "depressive illness." After review, this agency decided that the risks to pediatric patients outweigh the benefits of treatment with SSRIs, except fluoxetine (Prozac), which appears to have a positive risk-benefit ratio in the treatment of depressive illness in patients younger than 18 years.

In October 2003, the FDA issued a public health advisory regarding reports of suicidality in pediatric patients being treated with antidepressant medications for major depressive disorder. This advisory reported suicidality (ideation and attempts) in clinical trials of various antidepressant drugs in pediatric patients. The FDA has asked that additional studies be performed because suicidality was noted in treated and untreated patients with major depression and thus could not be definitively linked to drug treatment.


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