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March 22, 2019

UK MHRA recalls more batches of sartan medication

The UK Medicines and Healthcare Products Regulatory Agency has recalled three more batches of Losartan tablets amid fears of contamination with NMBA.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has recalled three batches of Losartan tablets amid fears of contamination caused by N-nitroso-N-methylamino butyric acid (NMBA).

The move is part of the regulatory authority’s continued investigation into potential contamination of sartan-based medicines, which are indicated to treat blood pressure and heart attacks.

Initially, the investigation revealed a nitrosamine N-nitrosodimethylamine (NDMA) based impurity in valsartan produced at a Chinese manufacturing plant.

UK authorities recalled batches of valsartan containing drugs manufactured by Dexcel Pharma and Accord Healthcare, part of the Actavis Group, from the market in July last year.

This was followed by recall of valsartan containing tablets in November due to possible NDMA as well as N-nitrosodiethylamine (NDEA) contamination.

In January and February this year, MHRA recalled irbesartan containing tablets that were found to potentially contain NDEA.

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Currently there is no evidence that nitrosamine impurities can cause harm and patients are being advised to continue taking their medication.

“There is no evidence at present that medicines containing NDMA, NDEA or NMBA have caused any harm to patients and this recall is a precautionary measure.”

MHRA Inspection, Enforcement and Standards division Regulatory Assessment unit manager Bernadette Sinclair-Jenkins said: “This recall shows we are continuing to investigate potential contamination of sartan containing medicines.

“There is no evidence at present that medicines containing NDMA, NDEA or NMBA have caused any harm to patients and this recall is a precautionary measure.”

The regulator advised patients to continue taking the medication because of the health risk from discontinuation. It will continue to monitor the contamination issue in alliance with the European Medicines Agency and the European Directorate for the Quality of Medicines.

The US Food and Drug Administration also recalled multiple batches of sartan-based products over the past year.

However, the US regulator recently permitted temporary distribution of losartan containing NMBA between 0.96ppm and 9.82ppm, until the impurity can be eliminated. The decision is intended to address the shortages of these drugs in the country.

Furthermore, individual companies also started voluntarily recall of these medications, including Sandoz, Mylan and Pfizer.

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