Blood pressure medication recall expands again to include losartan

Yet another blood pressure medication recalled for cancer risk

The Food and Drug Administration has expanded an already widespread recall of common blood pressure and heart failure medications. The active ingredient in each came from India-based Hetero Labs Limited.

The medicine is used to treat high blood pressure and congestive heart failure.

But patients should speak with their doctor to discuss the recall before they stop taking the drug.

Recent FDA analyses of NDMA and NDEA in the recalled drugs have found that "overall, the risk to individual patients is very low", but the agency added that those findings don't diminish the significance of this issue and that it continues to evaluate the risks posed to patients.

The recalled losartan potassium tablets made by Hetero Labs and distributed by Camber Pharmaceuticals contain the impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The contamination was found during heightened testing stirred by a far-reaching recall of generic blood-pressure drugs known as angiotensin II receptor blockers, or ARBs, that contain potential carcinogens NDMA and NDEA. Prinston Pharmaceutical identified China's Zhejiang Huahai Pharmaceuticals as the source of NDEA found in its hypertension medication recalled by the company last month.

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None of the companies have received reports of "adverse events" related to the recalls. This is the first ARB recall resulting from the presence of NMBA, which is the third type of nitrosamine impurity detected in ARB medicines.

According to USA Today, since 2015, the FDA has inspected more foreign factories than domestic ones, but a 2017 Government Accountability Office report found that in mid-2016, almost 1,000 foreign factories that produce United States drugs had gone uninspected.

"FDA scientists have developed novel and sophisticated testing methods specifically created to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in [angiotensin II receptor blocker (ARB)] medicines", Gottlieb wrote. "The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future".

More information about the losartan recall can be found on the FDA website.

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