The recalls of a widely-used hypertension drug due to carcinogenic impurities are expanding.
Hetero Labs Ltd. in India is recalling of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg), because they contain N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), a known animal and potential human carcinogen.
The losartan potassium tablets, made by Hetero Labs and distributed by Torrent Pharmaceuticals and Camber Pharmaceuticals, contain the impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
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“This is the first ARB (angiotensin II receptor blocker) recall resulting from the presence of NMBA, which is the third type of nitrosamine impurity detected in ARB medicines,” FDA said in a statement.
Plus, AurobindoPharma USA is expanding its recall to 38 lots of Valsartan and Amlodipine and Valsartan tablets due to the detection of trace amounts of the carcinogenic impurity, N-nitrosodiethylamine (NDEA)
The extensive blood pressure drug recalls began late last year, when ScieGen Pharmaceuticals recalled the antihypertensive drug irbesartan due to the presence of NDEA in the irbesartan API it received from Aurobindo Pharma Limited.
The update full list of recalled ARB products is available on FDA’s website.
The extensive new recalls came about because recent testing of the recalled lots of losartan potassium tablets showed NMBA levels higher than the FDA’s interim acceptable intake limits, the agency said. FDA’s evaluation suggests that the nitrosamines found in ARBs may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents.
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“We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB medications, but it’s important to underscore that, based on the FDA’s initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure,” said FDA Commissioner Scott Gottlieb, MD, in the statement. “That said, any presence of such impurities in drug products is not acceptable.”
Recent FDA analyses of NDMA and NDEA in recalled valsartan lots found that overall, the risk to individual patients is very low, although this doesn’t diminish the significance of this issue or the FDA’s concerns, the agency said. “The agency continues to evaluate the risks nitrosamines pose to patients. The FDA and drug manufacturers continue to test all ARBs for nitrosamine impurities. If NDEA, NDMA, NMBA, or other nitrosamine impurities are found in products at levels above the interim acceptable intake limits, the FDA will work with companies to swiftly remove affected products from the market.”
While not all ARBs contain nitrosamine impurities, “any patient taking an ARB from a recalled lot who has not yet spoken to their pharmacist or doctor should do so promptly,” the agency said. Patients taking an ARB medication from a recalled lot should continue taking their medicine until their doctor or pharmacist provides a replacement or a different treatment option.
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