Sanofi, eyeing impurity concerns, pulls hypertension meds in Korea and the U.K. Could the next big 'sartan' recall be on the horizon?

Sanofi
Sanofi and several other drugmakers have also pulled irbesartan meds in countries like Canada and the U.K. (Sanofi)

Looking to get the jump on impurity concerns first raised in Canada and Europe, Sanofi has rescinded a clutch of blood pressure drugs in Asia and the U.K. It's far from the only company whose meds are under scrutiny, potentially signaling the next widespread recall of a popular hypertension therapy. 

Sanofi is yanking three brands of hypertension tablets in Korea following a spate of safety-minded “sartan” drug recalls abroad, Korea Biomedical Review first reported. Specifically, the company is pulling tablets made in-country before January. All three products—Aprovel, CoAprovel and Rovelito—contain irbesartan, which has been tied to the discovery of azido impurities in multiple countries.

In the U.K., the Medicines and Healthcare Products Regulatory Agency on Monday issued its own azido recall notice for certain batches of Sanofi’s Aprovel and CoAprovel, plus film-coated irbesartan tablets made by Zentiva. Previously, the regulator flagged similar azido pulls for sartan drugs made by Bristol Laboratories, Teva UK and Brown & Burk.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) first flagged concerns about an azido impurity cropping up in certain sartan drug ingredients back in late April. Sartan drugs are used to treat high blood pressure and prevent heart attack and stroke.

In a similar recall notice from May covering irbesartan, losartan and valsartan, Health Canada identified the contaminant as a mutagen, or a chemical substance that can prompt a change in a cell’s DNA. Those mutations can increase the risk of cancer, the Canadian regulator said.

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Sanofi is conducting its Korea recall as a precautionary measure, Korea Biomedical Review reports. The company is “managing azido impurity” in its products made after January of this year but has “yet to derive results for azido impurity in finished goods manufactured before January 2021,” a Sanofi-Aventis Korea official said, as quoted by the publication.

Because azido testing results take time, the company decided to pull its irbesartan meds preemptively, the official said. Together, the irbesartan trio generated 16.9 billion Korean won ($14.7 million) for the first six months of the year. Sanofi has agreed to work in tandem with Korea’s Ministry of Food and Drug Safety, which is investigating the impurity issue, Korea Biomedical Review said.

Sanofi did not immediately respond to Fierce Pharma’s request for comment.

On May 30, Health Canada alerted the public that multiple drugmakers were recalling lots of irbesartan, losartan and valsartan after tests flagged azido impurities above acceptable limits. The original recall covered nine companies including Teva, Sandoz and Sun Pharma. Then, in mid-June, Sanofi-Aventis Canada added 12 lots of its prescription irbesartan tablets, sold as Avalide and Avapro, to Canada’s recall list.

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This isn’t the first time companies have pulled sartan drugs on impurity concerns. The FDA in 2018 discovered that the nitrosamines NDMA and NDEA—both of which are likely human carcinogens—could be created in certain manufacturing situations for sartan drugs. Following global recalls in 2018, valsartan supplies were squeezed in the U.S. in early 2019, the FDA said at the time.

Elsewhere, the popular diabetes drug metformin has been embroiled in a series of recalls over the past two years. After discovering NDMA in samples of the widely-used med, the FDA in May 2020 pushed five drugmakers—Apotex, Actavis, Amneal, Lupin and Marksans—to recall their extended-release metformin products. In the ensuing months, several companies have either joined the recall list or expanded their existing product pulls.