FDA-Approved Indications for Prozac (Fluoxetine)
Prozac (fluoxetine) is FDA-approved for treating major depressive disorder, obsessive-compulsive disorder, bulimia nervosa, panic disorder, and premenstrual dysphoric disorder. 1
Major Depressive Disorder (MDD)
- Approved for adults and children/adolescents (8 years and older)
- Fluoxetine is the only antidepressant FDA-approved for treating depression in children and adolescents 1
- Efficacy established in 5-6 week trials with depressed adult and geriatric outpatients
- Maintenance therapy has shown efficacy for up to 38 weeks following acute treatment
Obsessive-Compulsive Disorder (OCD)
- Approved for both adults and children/adolescents
- Effective dose range: 40-60 mg daily 2
- Efficacy established in 13-week trials with OCD outpatients
- Improvement typically observed after several weeks of therapy
- Often requires higher dosing (60-80 mg) for optimal efficacy compared to depression treatment 3
Bulimia Nervosa
- Approved for adults with moderate to severe bulimia (at least 3 bulimic episodes per week for 6 months)
- Efficacy established in 8-16 week trials
- Maintenance dose of 60 mg/day shown to prevent relapse for up to 52 weeks 1
Panic Disorder
- Approved for treatment with or without agoraphobia
- Efficacy established in two 12-week clinical trials 1
Bipolar Disorder
- Approved in combination with olanzapine 3
- Note: Lithium or mood stabilizers should be prescribed before antidepressants in bipolar patients 3
Premenstrual Dysphoric Disorder
- FDA approved for this indication 3
Safety Considerations
- Black box warning for increased risk of suicidality in children, adolescents, and young adults 3
- Lower lethal potential in overdose compared to tricyclic antidepressants 3
- Common side effects include gastrointestinal issues and nervous system effects 4
- Long half-life of fluoxetine and its active metabolite reduces withdrawal symptoms upon discontinuation 5
- Metabolized through CYP2D6, which can lead to potential drug interactions 3, 4
Special Populations
- Equally effective across age groups, including elderly patients 3
- Equally effective in men and women 3
- No significant differences in efficacy among racial subgroups 3
Clinical Considerations
- May be less effective than sertraline for patients with psychomotor agitation or melancholia 6
- Approximately 38% of patients may not respond during initial 6-12 weeks of treatment 6
- Regular evaluation of long-term usefulness is recommended for extended treatment periods 1
Fluoxetine has been widely prescribed since its introduction due to its proven efficacy (comparable to tricyclic antidepressants), ease of administration, generally benign side-effect profile, and remarkable safety in overdose 5.