From the Guidelines
Strattera (atomoxetine) has not been definitively linked to an increased risk of stroke in most patients, but caution is advised in individuals with pre-existing cardiovascular conditions due to its potential to cause modest increases in blood pressure and heart rate 1. When considering the use of Strattera, it's essential to weigh the potential benefits against the risks, particularly in patients with a history of cardiovascular disease. The medication's effects on blood pressure and heart rate, although typically mild, could theoretically increase stroke risk in vulnerable individuals.
Key Considerations
- Patients with pre-existing cardiovascular conditions, such as high blood pressure, heart disease, or previous stroke, should discuss these risks with their healthcare provider before starting Strattera.
- The medication should be initiated at a lower dose and gradually increased while monitoring cardiovascular parameters in these higher-risk patients.
- Regular blood pressure and heart rate checks are recommended during Strattera treatment, especially during dose adjustments.
- If symptoms such as severe headache, weakness on one side of the body, vision problems, or difficulty speaking occur while taking Strattera, immediate medical attention is necessary as these could indicate a stroke.
Mechanism and Monitoring
The mechanism behind Strattera's cardiovascular effects relates to its action as a norepinephrine reuptake inhibitor, which can affect blood vessel tone and cardiac function 1.
- Most patients without pre-existing cardiovascular risk factors can take Strattera safely with appropriate monitoring.
- Clinicians should obtain the personal and family cardiac history before starting nonstimulant medications like Strattera and perform additional evaluation if risk factors are present, including an electrocardiogram (ECG) and possibly referring to a pediatric cardiologist if the ECG is not normal 1.
From the FDA Drug Label
Serious Cardiovascular Events- Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment. The association between Strattera (Atomoxetine) and stroke is that stroke has been reported in association with atomoxetine treatment, particularly in patients with pre-existing cardiovascular disease. Patients should have a careful history and physical exam to assess for presence of cardiovascular disease before starting atomoxetine therapy 2.
From the Research
Association between Strattera (Atomoxetine) and Stroke
- There is no direct evidence in the provided studies that associates Strattera (Atomoxetine) with an increased risk of stroke 3, 4, 5, 6, 7.
- However, some studies suggest that atomoxetine may be associated with increased heart rate and blood pressure, which could potentially increase the risk of cardiovascular problems, including stroke 3, 4, 6, 7.
- One study found that atomoxetine was associated with statistically, but not clinically, significant increases in heart rate and blood pressure in pediatric patients with ADHD 3.
- Another study found that atomoxetine was associated with modest increases in heart rate and blood pressure, but these increases were well tolerated and gradually decreased on cessation of treatment 4.
- A review of the literature found that the risk of serious cardiovascular problems, including stroke, associated with atomoxetine and other ADHD medications is extremely low, and the benefits of treating ADHD outweigh the risks 6.
- A case report highlighted the potential for atomoxetine to cause cardiovascular side effects, including syncope, orthostatic hypotension, and tachycardia, particularly when interacting with inhibitors of the cytochrome P450 system 7.
Cardiovascular Side Effects
- Atomoxetine has been associated with various cardiovascular side effects, including increased heart rate and blood pressure, syncope, orthostatic hypotension, and tachycardia 3, 4, 6, 7.
- These side effects are generally considered to be rare and are often mild and transient 3, 4, 5.
- However, patients with a personal or family history of cardiovascular disease should be treated with caution when considering atomoxetine or other ADHD medications 6.