New contraindications, warnings, and advice for monitoring.
Article date: January 2012
Atomoxetine (Strattera▼) is a selective noradrenaline reuptake inhibitor for treatment of attention-deficit/hyperactivity disorder (ADHD) diagnosed according to DSM-IV criteria or ICD-10 guidelines, as part of a comprehensive treatment regimen. Treatment must be initiated by a specialist in the treatment of ADHD.
New data for risk of blood pressure and heart rate increase
A recent review of clinical trial data in children and adults with ADHD showed mean increases in blood pressure and heart rate with atomoxetine to be as previously estimated (blood pressure: <5 mm Hg; pulse: <10 beats per minute). However, approximately 6–12% of children and adults experienced clinically important changes in blood pressure (≥15–20 mm Hg) or heart rate (≥20 beats per minute), or both. Of these, 15–32% had sustained or progressive increases. Although there is no strong evidence from other data sources for an increased risk of adverse clinical cardiovascular or cerebrovascular outcomes, these increases in heart rate or blood pressure could have serious clinical implications for a small proportion of patients who take atomoxetine—especially when increases are sustained or progressive.
The contraindications, pretreatment screening, and ongoing cardiovascular risk monitoring recommendations for atomoxetine are now being strengthened so any potential risks can be minimised or avoided.
Key updated safety advice for healthcare professionals:
- atomoxetine should not be used in patients with severe cardiovascular or cerebrovascular disorders in which clinical deterioration would be expected with increases in blood pressure or heart rate that could be clinically important (eg, 15–20 mm Hg in blood pressure or 20 beats per minute in heart rate); examples of these severe cardiovascular or cerebrovascular disorders are included in the summary of product characteristics, letter for healthcare professionals, physician’s guide, and checklists
- patients being considered for atomoxetine treatment need a careful history and physical examination to assess any presence of cardiac disease. They should be referred for specialist cardiac evaluation if initial findings suggest such history or presence of cardiac disease
- before prescribing, the patient’s cardiovascular status, including blood pressure and heart rate, should be measured and recorded appropriately
- consider the balance of benefits and risks carefully when treating patients whose underlying medical conditions could be worsened by increased blood pressure and heart rate, such as those with hypertension, tachycardia, or cardiovascular or cerebrovascular disease not otherwise contraindicated
- cardiovascular status should be regularly monitored during treatment, with blood pressure and pulse recorded appropriately after every dose adjustment and at least every 6 months, to detect potentially clinically important increases
- patients who develop symptoms that suggest heart disease during atomoxetine treatment should undergo a prompt specialist cardiac evaluation
- patients with additional risk factors for cerebrovascular conditions (eg, history of certain cardiovascular diseases or concomitant use of medicines that elevate blood pressure) should be assessed at every visit for neurological signs and symptoms after initiating treatment with atomoxetine
yearly treatment review:
- patients who take atomoxetine for extended periods (ie, >1 year) should have their treatment reviewed at least once a year by a specialist to determine whether continuation is needed
Additional tools for management of cardiovascular risks
The licence holder for Strattera has developed a physician’s guide to prescribing, and additional tools that should be used for cardiovascular screening and monitoring of patients.
Suspected adverse reactions to atomoxetine should be reported to us on a Yellow Card, available at www.mhra.gov.uk/yellowcard
NICE guidance on attention-deficit/hyperactivity disorder
Guidelines from the European Network for Hyperkinetic Disorders (EUNETHYDIS)