Can Strattera (atomoxetine) increase blood pressure (hypertension) in patients, particularly those with pre-existing hypertension or cardiovascular disease?

Does Strattera Raise Blood Pressure?

Yes, Strattera (atomoxetine) does increase blood pressure and heart rate, and should be used with caution in patients with pre-existing hypertension or cardiovascular disease. 1

Magnitude of Blood Pressure Effects

The FDA label clearly documents that atomoxetine causes measurable increases in both blood pressure and heart rate 1:

• In pediatric patients: 21.5% experienced diastolic BP increases ≥15 mmHg (vs 14.1% placebo), and 12.5% had systolic BP increases ≥20 mmHg (vs 8.7% placebo) 1
• In adult patients: Similar proportions showed clinically significant BP elevations, with mean increases of approximately 2-4 mmHg systolic and diastolic 1
• Heart rate increases: Mean increase of 5 beats/minute in extensive metabolizers and 9.4 beats/minute in poor metabolizers (CYP2D6 PM patients) 1

Research confirms these findings, showing small but statistically significant increases in mean systolic blood pressure in adults and diastolic blood pressure in children and adolescents, with increases tending to occur early in therapy 2.

Clinical Significance and Risk Stratification

High-Risk Patients Who Should Avoid Atomoxetine

Atomoxetine should NOT be used in patients with severe cardiac or vascular disorders whose condition would be expected to deteriorate with clinically important increases in blood pressure or heart rate 1. This includes:

• Patients with uncontrolled hypertension 3
• Those with significant cardiovascular disease 1
• Patients with cerebrovascular disease 1
• Individuals with tachycardia 1

Patients Requiring Extreme Caution

Atomoxetine should be used with caution in patients whose underlying medical conditions could be worsened by increases in blood pressure or heart rate, such as certain patients with controlled hypertension, tachycardia, or cardiovascular/cerebrovascular disease 1.

Cardiovascular Monitoring Requirements

The FDA mandates specific monitoring protocols 1:

• Baseline assessment: Measure pulse and blood pressure before starting treatment 1
• During dose titration: Check BP and pulse following each dose increase 1
• Ongoing monitoring: Measure periodically throughout therapy to detect clinically important increases 1
• Cardiac screening: Obtain careful history (including family history of sudden death or ventricular arrhythmia) and physical exam to assess for cardiac disease 1

Patients who develop exertional chest pain, unexplained syncope, or other cardiac symptoms during treatment should undergo prompt cardiac evaluation 1.

Special Considerations for CYP2D6 Poor Metabolizers

Poor metabolizers (PM) of CYP2D6 experience significantly greater cardiovascular effects 1:

• Mean heart rate increase of 11 beats/minute in PMs vs 7.5 beats/minute in extensive metabolizers 1
• Mean diastolic BP increase of 4.21 mmHg in PMs vs 2.13 mmHg in extensive metabolizers 1
• These effects could be clinically important in some PM patients 1

When atomoxetine is used with potent CYP2D6 inhibitors (fluoxetine, paroxetine, quinidine) or in known CYP2D6 poor metabolizers, dose adjustment may be necessary 1.

Additional Cardiovascular Risks

Beyond hypertension, atomoxetine carries other cardiovascular warnings 1:

• Sudden death reported in children/adolescents with structural cardiac abnormalities 1
• Stroke and myocardial infarction reported in adults at usual ADHD doses 1
• Orthostatic hypotension and syncope: Reported in 0.2% of pediatric patients and documented in case reports 1, 4
• Tachycardia: Identified as adverse event in 0.3% of pediatric and 1.5% of adult patients 1

Practical Management Algorithm

For patients with pre-existing hypertension considering atomoxetine:

1. Ensure blood pressure is well-controlled (ideally <140/90 mmHg) before initiating atomoxetine 1
2. Screen for structural cardiac abnormalities with history, physical exam, and consider ECG/echocardiogram if indicated 1
3. Start at lower doses and titrate slowly while monitoring BP and pulse 1
4. Monitor BP and pulse at baseline, with each dose increase, and regularly during maintenance 1
5. Consider alternative ADHD treatments if hypertension is uncontrolled or patient has significant cardiovascular disease 1

Common Pitfall to Avoid

Do not assume that because cardiovascular effects are "small" on average (mean increases of 2-4 mmHg), they are clinically insignificant 2. Individual patients, particularly CYP2D6 poor metabolizers or those with pre-existing cardiovascular conditions, may experience substantially larger increases that could precipitate cardiovascular complications 1, 4.