The recall from pharmacies and wholesalers is due to an increased risk of cancer from an impurity in the contaminated batches
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall for 25 batches of irbesartan-containing medicinal products due to contamination with an impurity that could potentially increase the risk of cancer over time.
The MHRA said the recall—which is for pharmacies and wholesalers and not a patient-level recall—of the antihypertensive drug is a precautionary measure to prevent further use, and there is no evidence that this impurity (5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole) has caused any harm to patients.
Recalled batch numbers can be found in the MHRA’s class 2 medicines recall alert. The MHRA said it is working with the DHSC to ensure that an adequate supply of these products remains available for patients. The agency has advised that patients should not stop any treatments without consulting their healthcare team, particularly medications for the control of hypertension.
Commenting on the recall, Dr Alison Cave, MHRA Chief Safety Officer, said: ‘Patient safety is at the heart of what we do. We’re recalling batches of certain sartan-containing products as a precautionary measure while we continue our investigation. It’s important that healthcare professionals check their stock to quarantine and return these batches.’
Sartan-containing medicines are indicated for essential hypertension, heart failure, and treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive regimen.
Previous recalls of these types of products in 2018, 2019, and June 2021 are part of an ongoing investigation. The MHRA said it is working with other medicines regulators on this issue.