MHRA Drug Safety Update: Increases in blood pressure and heart rate with atomoxetine (Strattera®)

Reference: Ref: MHRA Drug Safety Update 2012; 5(6):

Source: MHRA

Date published: 13/01/2012 15:12

Summary
by: Nicola Pocock

The January 2012 issue of Drug Safety Update from the MHRA advises healthcare professionals of new contraindications, warnings, and advice for monitoring of atomoxetine (Strattera), due to clinically important increases in blood pressure or heart rate (or both) observed in a small proportion of patients.

 

A recent review of  clinical trial data in children and adults with ADHD showed that 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, and that the increases were sustained or progressive in 15–32% of these.  As such increases could have serious clinical implications for a small proportion of patients who take atomoxetine, its contraindications and the recommendations for pre-treatment screening and ongoing cardiovascular risk monitoring are now being strengthened.  Please see the link below for further information.

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