The Medicines and Healthcare products Regulatory Agency (MHRA) stressed that they are recalling batches of the drugs from pharmacies and suppliers rather than patients and that there is no evidence they have caused harm, although investigations are ongoing.
The recall affects 31 batches of drugs containing Irbesartan and 2 containing Losartan, medicines which are used to treat high blood pressure, heart failure, type 2 diabetes and kidney disease in adults who also have high blood pressure.
Patients who take the affected drugs should speak to a doctor or pharmacist, the MHRA say, and should not stop taking their medicine without doing so. Government advice states that the health risk of suddenly stopping medication is higher than the potential risk posed by the impurity.
Dr June Raine, chief executive of the MHRA, called on healthcare staff to check their batches of sartan-containing drugs while the agency further investigates the issue.
“Patient safety is our watchword. 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,” she said.
“If you’ve been taking one of the affected products, speak with your doctor or pharmacist before stopping any treatment – they can address any concerns and can advise you on the best course of action.”
The MHRA say that they have contacted UK licence holders of affected batches and asked them to quarantine the relevant stock.
They added that they are working with the Department of Health and Social Care to make sure that there are enough drugs available for people who ordinarily take them.
The MHRA is also working with the Marketing Authorisation Holders and other medicines regulators to determine any possible impact of contamination.
The 33 batches that have been recalled were supplied by Bristol Laboratories Limited, Brown & Burk UK Limited and Teva UK Limited.
The mutagenic impurity they contain is called 5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole, which can potentially increase the risk of cancer over time.
A full list of the affected batches can be found here.
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