A European procedure for the assessment of periodic safety reports (PSUR Single Assessment) was carried out for medicinal products containing the active substance atomoxetine. Based on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) adopted a unanimous decision. According to this decision, the summary of product characteristics and package leaflets for medicinal products containing the active substance atomoxetine must be adapted to the current state of scientific knowledge. The BfArM implemented the CMDh decision with its decision of 13 January 2025.

According to the PRAC assessment report, a connection between atomoxetine and observed cases of serotonin syndrome as well as physical assaults or threatening behaviour and thoughts, including homicidal thoughts, is considered possible.

To the risk information (available in German only)