FDA Approvals for SSRIs
No SSRIs currently have FDA approval for anxiety disorders, despite substantial evidence supporting their use in these conditions. 1
FDA-Approved Indications by SSRI
Fluoxetine (Prozac)
- Major depressive disorder (including children/adolescents ≥8 years—the only SSRI approved for pediatric depression) 1
- Obsessive-compulsive disorder 1
- Bulimia nervosa 1
- Premenstrual dysphoric disorder 1
- Panic disorder 1
- Bipolar disorder (in combination with olanzapine) 1
Paroxetine (Paxil)
- Major depressive disorder 1
- Obsessive-compulsive disorder 1
- Panic disorder 1
- Social anxiety disorder 1
- Premenstrual dysphoric disorder 1
- Generalized anxiety disorder 1
- Post-traumatic stress disorder 1, 2
Sertraline (Zoloft)
- Major depressive disorder 2
- Obsessive-compulsive disorder 2
- Panic disorder 2
- Post-traumatic stress disorder 2
- Social anxiety disorder 2
- Premenstrual dysphoric disorder 2
Citalopram (Celexa)
No specific FDA approvals beyond major depressive disorder are documented in the provided evidence, though it is widely used off-label for anxiety disorders 1
Escitalopram (Lexapro)
No specific FDA approvals are detailed in the provided evidence, though it is the active enantiomer of citalopram and used for depression and anxiety 1, 3
Fluvoxamine (Luvox)
Obsessive-compulsive disorder is the primary documented indication 1
Critical Clinical Context
Black Box Warnings
All SSRIs carry a black box warning for suicidal thinking and behavior through age 24 years, with pooled absolute rates of suicidal ideation at 1% for antidepressant-treated youth versus 0.2% for placebo 1
Anxiety Disorders
Despite robust evidence demonstrating SSRI efficacy for social anxiety, generalized anxiety, separation anxiety, and panic disorder in both adults and children (ages 6-18), no SSRIs have received FDA approval specifically for these anxiety indications 1. This represents a significant gap between evidence-based practice and regulatory approval.
Pediatric Considerations
Lithium is the only psychotropic medication with FDA approval for bipolar disorder in youth (≥12 years), though this was based historically on adult literature 1. Fluoxetine remains the sole SSRI approved for pediatric major depression 1.
Geriatric Recommendations
Preferred SSRIs for older adults include citalopram, escitalopram, and sertraline, while paroxetine and fluoxetine should generally be avoided due to higher adverse effect rates in this population 1