FDA Approval Status of Prozac (Fluoxetine) for Panic Disorder
Yes, Prozac (fluoxetine) is FDA approved for the treatment of panic disorder, with or without agoraphobia. 1
FDA Approval Details
Prozac is specifically indicated for panic disorder as defined in DSM-IV, characterized by:
- Recurrent, unexpected panic attacks
- Associated concern about having additional attacks
- Worry about implications or consequences of attacks
- Significant change in behavior related to the attacks 1
Dosing for Panic Disorder
The FDA-approved dosing regimen for panic disorder is:
- Initial treatment: Start at 10 mg/day
- After 1 week: Increase to 20 mg/day
- Most common effective dose: 20 mg/day
- Maximum studied dose: 60 mg/day 1
Lower or less frequent dosing should be considered for:
- Patients with hepatic impairment
- Elderly patients
- Patients with concurrent disease or on multiple medications 1
Clinical Evidence Supporting Use
Clinical trials supporting FDA approval demonstrated efficacy in two 12-week trials in patients with panic disorder 1. Research shows that:
- Starting with lower doses (5-10 mg/day) and gradually increasing to 20 mg/day may improve tolerability, especially in patients with comorbid panic disorder and depression 2
- Fluoxetine at 20 mg daily is safe and efficacious in reducing symptoms of panic disorder 3
- Patients who don't respond adequately to 20 mg/day may benefit from dose increases up to 60 mg/day 3
Treatment Duration Considerations
While the FDA notes that the effectiveness of Prozac in long-term use (beyond 12 weeks) has not been established in placebo-controlled trials, it is recognized that panic disorder is a chronic condition 1. Therefore:
- It is reasonable to consider continuation for responding patients
- Periodic reassessment should be conducted to determine the need for continued treatment
- A gradual reduction in dose rather than abrupt cessation is recommended when discontinuing 1
Special Considerations
Tolerability: Some patients with panic disorder may be particularly sensitive to side effects. Starting at lower doses (5 mg/day) may help improve tolerability 2, 4
Maintenance therapy: Once stabilized, some patients may be maintained on once-weekly dosing due to the long half-life of fluoxetine and its active metabolite norfluoxetine 5
Treatment goals: Treatment should target not only panic attack frequency but also associated symptoms like phobic avoidance, anxiety, and functional impairment, as these correlate more strongly with overall clinical improvement 6
Black box warning: As with other SSRIs, Prozac carries a black box warning for increased risk of suicidal thinking and behavior in children, adolescents, and young adults 7
In summary, Prozac is FDA-approved for panic disorder and represents an effective treatment option with established dosing guidelines and safety profile. Starting at lower doses and gradually titrating up may improve tolerability in this population.