Two-Week Follow-Up After Starting Antidepressant with Black-Box Warning
Yes, a two-week follow-up is appropriate and aligns with guideline recommendations for monitoring patients started on antidepressants with black-box warnings, even in those without baseline suicidal ideation. 1, 2
Rationale for Two-Week Monitoring Interval
The FDA black-box warning specifically calls for "close monitoring during the first few months of treatment and after dose changes," with particular emphasis on the early treatment period. 1 The American Academy of Pediatrics recommends assessment within 1 week of treatment initiation (in-person or by telephone), followed by regular monitoring throughout the first few months. 2
The highest risk period is actually the first 1-9 days after starting an antidepressant, with the relative risk of suicidal behavior being 4.07 times higher compared to patients who have been on treatment for 90 days or more. 3 For completed suicide, this risk jumps to 38.0 times higher in the first 1-9 days. 3 Therefore, your two-week follow-up captures this critical early window.
What to Monitor at the Two-Week Visit
At every contact during early treatment, systematically assess the following five domains: 2
- Ongoing depressive symptoms – Is the depression improving, stable, or worsening? 2
- Suicide risk – Directly ask about new or worsening suicidal thoughts, plans, or intent 1, 2
- Adverse effects – Screen specifically for akathisia (restlessness), which has been associated with antidepressant-induced suicidality 4, 2
- Adherence to treatment – Confirm the patient is taking medication as prescribed 2
- Environmental stressors – Identify any new psychosocial factors that could increase risk 2
Specific Warning Signs to Educate Family About
Provide the patient and family with clear instructions to contact you immediately if any of these occur: 1
- New or more frequent thoughts of wanting to die 1
- Self-destructive behavior 1
- Signs of increased anxiety, panic, agitation, aggressiveness, or impulsivity 1
- New or worsening insomnia or irritability 1
- Involuntary restlessness such as pacing or fidgeting (akathisia) 1
- Extreme elation, energy, fast speech, or unrealistic plans 1
Critical Context About the Black-Box Warning
The actual risk increase is quite small. Reanalysis of FDA data showed only a 0.7% increase in suicidal ideation or behavior with antidepressants (from 2% with placebo to approximately 2.7% with medication). 1 No completed suicides occurred in any of the 24 clinical trials involving over 4,400 patients. 1
More importantly, the risk of NOT treating depression is significantly higher than the risk of treatment. After the FDA black-box warning reduced antidepressant prescribing by 22%, youth suicide rates increased by 14% in the United States and 49% in the Netherlands. 1, 2 Psychotropic medication poisonings (a proxy for suicide attempts) increased 21.7% in adolescents after the warning. 1, 2
Beyond Two Weeks
Continue close monitoring throughout the first few months of treatment, with particular vigilance after any dose changes. 1, 2 The risk remains elevated during the first month but decreases substantially after 90 days of treatment. 3
Your approach of warning about the black-box risk while proceeding with treatment in a patient without baseline suicidal ideation, combined with a two-week follow-up, represents evidence-based, guideline-concordant care. 1, 2