BlackBoxRX
 
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Fluoxetine

Antidepressant and Suicidality

Antidepressant and Suicidality

  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluoxetine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Fluoxetine is approved for use in pediatric patients with MDD and Obsessive Compulsive Disorder (OCD).

Sexual Dysfunction

  • Use of SNRIs may cause symptoms of sexual dysfunction. In male patients, SNRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SNRI use may result in decreased libido and delayed or absent orgasm.
  • It is important for prescribers to inquire about sexual function prior to initiation of SNRI's and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported. When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder. Discuss potential management strategies to support patients in making informed decisions about treatment.


When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for olanzapine and fluoxetine hydrochloride capsules.


MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Close observation for suicidal thinking or unusual changes in behavior

FDA and Industry Communications

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Fluoxetine

Additional Information

Updated October 2021