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MHRA issues further recall for irbesartan

The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled more irbesartan-containing blood pressure and heart medication from UK pharmacies as it continues to investigate possible contamination of sartan products.

The recall, announced 24 January 2019, has been described by the regulatory body as a precautionary measure after testing revealed possible N-nitrosodiethylamine (NDEA) contamination.

The MHRA said there was “no evidence at present that the impurity has caused any harm to patients and not all irbesartan products are affected”.

This latest recall affects three batches of irbesartan 150mg and 300mg tablets, which is supplied by Macleods Pharma UK. 

Because of the risk associated with suddenly stopping medication for high blood pressure, patients are advised to continue to take their medicines and to speak to a doctor or pharmacist if they have any concerns, the agency said.

Earlier in January 2019, the MHRA advised pharmacies to recall all affected batches of irbesartan-containing medicines made by Actavis.

Valsartan-containing medicines supplied by Dexcel and Actavis (now Accord) were recalled in July 2018 followed by a further recall of batches of valsartan-containing medicines supplied by Mylan and Teva in November 2018, owing to concerns over NDEA and N-nitrosodimethylamine contamination.

The MHRA said it is continuing to investigate the contamination issue alongside the European Medicines Agency and the European Directorate for the Quality of Medicines.

Sam Atkinson, director of the inspection, enforcement and standards division at the MHRA, said: “We continue to investigate [the] potential contamination of sartan-containing medicines, such as irbesartan. We will continue to act and provide updates when appropriate.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206061

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