Common blood pressure drugs are being recalled by the UK medicine regulator over fears of contamination with a substance that can increase the risk of cancer over time.
The MHRA yesterday issued a recall for 31 batches of Irbesartan-containing medicinal products and two batches of Losartan-containing medicinal products due to contamination.
The advice being given is that patients should not stop any treatments without consulting their doctor or pharmacist.
The MHRA has said the recall is a precautionary measure while they investigate and there is no proof of any harm to patients.
This recall is for pharmacies and wholesalers, and not at patient-level.
Dr June Raine, MHRA Chief Executive, said : "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.
"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 affected batch numbers can be found here.
A description of the problem on the UK government site says: "Bristol Laboratories Limited, Brown & Burk UK Ltd and Teva UK Ltd are recalling the above batches of products as a precautionary measure due to contamination with an impurity called 5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole, which has mutagenic potential.
These batches are being recalled as the level of contamination is above the acceptable limit."
Advice for healthcare professionals on the government website adds: "Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
"Patients are advised not to stop taking their medication prior to consultation with their doctor or pharmacist, as the health risk of discontinuing the medicine is higher than the potential risk presented by the impurity.
"This recall is being undertaken as a precautionary measure to prevent further exposure to this impurity in the affected medicines whilst the investigation is ongoing.
"There are no anticipated shortages of irbesartan-containing and losartan-containing products in the UK as a result of this recall.
"However, this is a developing issue and MHRA is working with Marketing Authorisation Holders and other medicines regulators to determine any possible impact. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses."
