October 23rd 2023
We have received further clarification from GSK on the resupply of Zyban (bupropion hydrochloride 150 mg):
• As directed by regulatory authorities (including EMA and US FDA) GSK, along with other Pharmaceutical Industries, have been reviewing our products for the potential presence of nitrosamine impurities. As part of this programme, we conducted testing on Zyban tablets.
• In October, 2022 the EMA introduced a temporary Acceptable Intake (AI) limit of 178ng/day for marketed medicines containing one or more nitrosamines until formal AI were established. Zyban tablets were placed on hold at this time as a precautionary measure until the permanent limit was established.
• In July 2023, the EMA removed this temporary (AI) limit and a formal limit of 1500ng/day was published for N-nitroso buproprion. The MHRA is aligned with EMA’s position and the published limit for N-nitroso buproprion. As a result of the published limit we have resumed supply of Zyban across the EU and the UK.
• The risk/benefit of Zyban’s use for smoking cessation remains positive when taken in accordance with the prescribing information.
The NCSCT has completed the process of updating information on its website and e-learning programme.
October 16th 2023
Bupropion (Zyban) is now back in stock and being supplied.
More details to follow. The NCSCT is in the process of updating information on its website and e-learning programme.
Adverse Event Profile Changes
Only one change has occurred since Zyban was out of stock. This was in Section 4.4 Special Warnings and Precautions where the following was added:
Bupropion may unmask Brugada syndrome, a rare hereditary disease of the cardiac sodium channel with characteristic ECG changes (ST segment elevation and T wave abnormalities in the right precordial leads), which may lead to cardiac arrest and/or sudden death. Caution is advised in patients with Brugada syndrome or risk factors such as a family history of cardiac arrest or sudden death.
The full Zyban Summary of Product characteristics can be found here: https://www.ncsct.co.uk/publication_bupropion.php
On 1st December 2022 GSK placed an immediate hold on the batch release and distribution into EU markets (including the UK and Switzerland) of Zyban (bupropion hydrochloride) 150 mg prolonged release tablets.
GSK has been reviewing its manufacturing processes for the potential presence of nitrosamine impurities. GSK conducted testing and the results indicate there is the potential for the presence of nnitroso-bupropion.
GSK has initiated a root cause investigation is determining the best course of action. At this point it's not possible to provide an indication of timings for the Root Cause Analysis completion as this is due to the complexity of the investigation. GSK will provide an update when available.
On this page is an advisory document summarising alternatives to bupropion and an FAQ document that might be helpful.