Atomoxetine (STRATTERA) - risk of increased blood pressure and/or heart rate

Safety advisory

2 November 2011

The TGA is advising health professionals and patients of important safety information regarding the risk of increased blood pressure and/or heart rate with the use of atomoxetine (STRATTERA®). These effects could represent a risk for some patients.

The new recommendations and precautions when prescribing this medicine are outlined below.

This risk was identified from an analysis of combined data from clinical trials sponsored by atomoxetine's sponsor, Eli Lilly.

Atomoxetine is a selective noradrenaline reuptake inhibitor indicated for treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adults.

Information for patients

You should NOT stop taking atomoxetine or change the dose without first consulting your doctor.

If you have high blood pressure, fast heart rate or heart disease, have had a stroke or have been diagnosed with a heart condition known as QT prolongation, you should discuss with your doctor the need for monitoring of your heart rate and blood pressure while on atomoxetine.

Information for health professionals

Atomoxetine can cause clinically significant increases in heart rate and blood pressure in some patients. Health professionals are advised of the following contraindications, precautions and recommendations for screening and monitoring patients who are being treated with this medicine:

Atomoxetine is contraindicated in patients with symptomatic cardiovascular diseases, moderate to severe hypertension or severe cardiovascular 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.

Atomoxetine should be used with caution in patients with congenital or acquired QT prolongation or a family history of QT prolongation.

Patients should be screened for pre-existing or underlying cardiovascular or cerebrovascular conditions before initiation of treatment with atomoxetine, and monitored during the course of treatment.

Heart rate and blood pressure should be measured in all patients before treatment with atomoxetine is started, after the dose is increased, and periodically during treatment to detect possible clinically important increases, particularly during the first few months of therapy.

Eli Lilly Australia is writing to Australian health professionals to advise them of these changes.

The Product Information (PI) for atomoxetine is currently being updated and the new PI will be placed on the TGA website shortly.

Reporting an adverse event

Patients and health professionals are encouraged to report adverse reactions associated with atomoxetine to the TGA. Your report will contribute to our monitoring of this medicine.

The TGA cannot give personal advice about an individual's medical condition. Consumers are strongly encouraged to talk with a health professional if they are concerned about a possible adverse reaction to any medicine.