Lilly have issued a letter advising healthcare professionals of important safety information on atomoxetine (Strattera®) and risks of increased blood pressure and heart rate.
A recent analysis of combined data from company-sponsored studies of atomoxetine has indicated that around 6-12% of patients experience clinically important changes in heart rate (≥20 bpm) or blood pressure (≥15-20mmHg), and that 15-32% of these patients had sustained or progressive increases.
These side-effects could be a potential risk to patients with severe cardiovascular or cerebrovascular disorders and therefore the company has recommended changes to the prescribing information, as follows:
• Atomoxetine should not be used in patients with severe cardiovascular or cerebrovascular disorders whose condition would be expected to deteriorate if they experienced increases in blood pressure or in heart rate that could be clinically important.
• 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 patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease.
• It is recommended that patients being considered for treatment with atomoxetine have a careful history and physical examination to assess for the presence of cardiac disease. Patients should be referred for specialist cardiac evaluation if initial findings suggest such history or presence of cardiac disease.
• Heart rate and blood pressure should be measured and recorded in all patients before treatment with atomoxetine is started as well as after each dose adjustment and then at least every six months during treatment to detect possible clinically important increases. If patients develop symptoms suggestive of cardiac disease during treatment they should be referred for prompt specialist cardiac evaluation.
The Company has produced a Physician’s Guide to Prescribing and additional tools that should be used for cardiovascular screening and monitoring of patients (available at www.lillypro.co.uk; registration required).
Added 6/1/12 - The letter and Physician's Guide are available at the links below (via the MHRA website).