The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a precautionary warning on 25 batches of medicinal productsthat contain Irbersartan.
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Irbesartan is a drug that is commonly used to treat high blood pressure, heart failure, and kidney disease.
Precautionary measure
They’ve recalled the medicines because it has been contaminated with an impurity that could potentially increase the risk of cancerand ‘level of contamination is above the acceptable limit.’ However, given that the impurity has not caused any harm to patients so far, they have only issued the recall to pharmacies and wholesalers. MHRA published on GOV.UK:
This 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. The recall is for pharmacies and wholesalers and is not a patient-level recall.
Daily Mail reported that some of the affected pills have been on the market since December 2018, and last month the MHRA had issued a similar recall for 31 batches of drugs that had the same impurity.
Risk of discontinuing medication
The agency has stressed that patients should continue taking the medication as it could be dangerous to stop the treatment all of a sudden. Instead, patients who have been prescribed the affected medication should contact their healthcare team immediately and carry on with the dosage until told otherwise. Dr. Alison Cave, MHRA Chief Safety Officer said:
If you’ve been taking one of the affected products, continue to take your medication. 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.
Previous recalls of these types of products in 2018, 2019 and June 2021 are part of an ongoing investigation. The MHRA is working with other medicines regulators on this issue.
