Based on the evaluation of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing bupropion, the Pharmacovigilance Risk Assessment Committee (PRAC) drew the following conclusions.
In view of the available data on Brugada syndrome from spontaneous reports, including two cases with a close temporal relationship and a positive re-challenge and de-challenge test, and in view of a plausible mechanism of action described in the literature, the PRAC considers that bupropion may manifest Brugada syndrome. Therefore, physicians should be advised to be cautious with patients with a family history of cardiac arrest or sudden death. Patients should also be properly informed about this issue. The PRAC concluded that the instructions for medical use of medicinal products containing bupropion should be amended accordingly.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the scientific conclusions drawn by the PRAC.
Based on the scientific conclusions, the CMDh considers that the benefit/risk balance of medicinal products containing bupropion remains unchanged, provided that the appropriate changes are made to the instructions for medical use.
Changes to be included in the relevant sections of the instructions for medical use (new text underlined in bold, deleted text struck through).
Section “Special warnings and precautions for use”
Brugada syndrome
Bupropion may unmask Brugada syndrome, a rare hereditary disorder of the cardiac sodium channel with characteristic ECG changes (right bundle branch block and ST-segment elevation in the right precordial leads), which can lead to cardiac arrest or sudden death.
Перелік лікарських засобів, що містять бупропіон (bupropion) і дозволені до медичного застосування в Україні (за даними Державного реєстру лікарських засобів станом на 07.12.2022).
For the analysis of the published information, the applicant must use the original text available at the link:
