Why is there a black box warning on Luvox?

There is a black box warning on Luvox (fluvoxamine) because research shows the drug may increase suicidal thoughts or behaviors in children, teens and young adults who take it. Luvox is prescribed to treat obsessive-compulsive disorder (OCD) in children ages 8 to 17. It belongs to a category of drugs called selective serotonin reuptake inhibitors (SSRIs), which work by adjusting the level of the chemical serotonin in the brain. Serotonin is thought to have several functions, including regulating mood.

In studies, about 4% of children and teens who took SSRIs experienced suicidal thoughts or behaviors (including attempts) compared to about 2% of similar children and teens who took placebos ("sugar" pills). If your child or teen takes Luvox, his doctor may recommend you watch for signs of potentially dangerous changes in his mental health, including:
  • new or worsening depression
  • thoughts about harming or killing himself or others
  • extreme worry or agitation
  • panic attacks
  • trouble sleeping
  • irritability
  • impulsive behavior
  • restlessness
  • increase in activity or talking
Call the doctor if your child exhibits these changes. Make sure your child does not stop taking Luvox without talking to the doctor first. Stopping Luvox suddenly may cause or worsen these or other symptoms. Your child's doctor may reduce the dose of Luvox gradually to minimize withdrawal symptoms.

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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.