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.
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.
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.
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.