In November 2011, the European Pharmacovigilance Working Party (PhVWP) concluded that new knowledge should be communicated about the known risk of increased blood pressure and heart rate associated with the use of atomoxetine, which is authorised for the treatment of ADHD (Attention-Deficit/Hyperactivity Disorder).
A recent analysis of the total data from controlled and non-controlled clinical trials of atomoxetine has shown changes in blood pressure and heart rate that were higher than expected.
A share of patients (approx. 6-12 % of children and adults) experienced changes in the heart rate (20 bpm or greater) or blood pressure (15-20 mmHg or greater).
About 15-32 % of the patients who experienced changes in blood pressure and heart rate in connection with atomoxetine-treatment had persistent or progressive changes.
The summary of product characteristics will soon be updated with the new information.