Why is there a black box warning on Paxil?

Paxil (paroxetine) and other antidepressant medications have a black box warning because research indicates that they can increase the risk of suicidal thoughts and attempts in children, teens and young adults up to and including age 24. Paxil belongs to a category of drugs called selective serotonin reuptake inhibitors, or SSRIs, which improve depression, anxiety and other mental health problems by adjusting the level of the chemical serotonin in the brain.

In 2005, the Food and Drug Administration (FDA) began requiring a black box warning on all packages of SSRIs after a review of clinical trials of children and teens who were being treated for mental health issues with an SSRI found that 4% experienced suicidal thinking or behaviors, about twice the rate of children and teens who took a placebo. However, the benefits of taking Paxil for children and teens who are depressed may outweigh the risks. Research shows that major depressive disorder affects about 5% of teens and that depression improves in more than 60% of teens who take an SSRI alone, and in more than 70% of those who take an SSRI and get cognitive behavioral therapy.

Paxil is approved to treat depression in adults, but doctors often prescribe it "off label" to treat depression and other mental health illnesses in children and teens as well. Parents, their children, and their children's doctors need to work together to weigh the potential risks and benefits of Paxil for children and teens who are experiencing depression and other mental health problems.

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Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.