The UK’s medicines watchdog has recalled certain batches of irbesartan-containing products, made by several manufacturers, over concerns that the drugs have come into contact with a potentially cancerous substance.
This is the second time irbesartan-containing products have been recalled by the Medicines Healthcare Regulatory Agency (MHRA), after being recalled in June of this year.
Related Article: Turbo-charge community pharmacy to save A&E millions of hours, says NPA
The products are being recalled as a ‘precautionary measure’ to ‘prevent further exposure,’ following contamination with 5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole.
The recalled lines include batches from Sanofi, Doncaster Pharmaceuticals Group Lt, MPT Pharma Limited, PCO Manufacturing Ltd, Gowrie Laxmico Ltd T/A B&S Healthcare and Zentiva Pharma UK Ltd.
The identified substance has ‘mutagenic potential,’ which means it could permanently damage or change DNA by causing cancer.
These batches are being recalled as the level of contamination with the mutagenic substance is above the acceptable limit.
Related Article: MHRA recalls medication with label error
Healthcare professionals have been told to stop supplying the listed batches immediately, to quarantine all remaining stock and return it to the supplier.
Irbesartan-containing medicinal products are often used to treat high blood pressure. Patients who are taking the affected medications are advised to consult their health team before stopping taking it, the MHRA said.
Related Article: Pharmacy luminary makes history with RCGP honorary fellowship
The medicines watchdog said there are no anticipated supply issues of irbesartan-containing products in the UK.
An investigation into other potentially impacted products is ongoing, they added.
Have your say
Please add your comment in the box below. You can include links, but HTML is not permitted. Please note that comments are not moderated before publication and the views expressed are those of the user and do not reflect the views of The Pharmacist. Remember that submission of comments is governed by our Terms and Conditions. You can also read our full guidelines on article comments here – but please be aware that you are legally liable for any libellous or offensive comments that you make. If you have a complaint about a comment or are concerned that a comment breaches our terms and conditions, please use the ‘Report this comment’ function to alert our web team.