Medicine

Blood pressure medication recall expands again to include losartan

Blood pressure medication recall expands again to include losartan

The latest recalls are for 38 lots of Valsartan and Amlodipine and Valsartan tablets produced by AurobindoPharma USA due to "the detection of trace amounts of an unexpected impurity found in the finished drug", and 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, from Torrent Pharmaceuticals.

The U.S. Food and Drug Administration announced two more recalls of blood pressure medication Friday because potentially carcinogenic impurities were found in them.

The affected medication has trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), which is classified as a potential human carcinogen.

As for the latest recall, the FDA has reminded patients prescribed an ARB medication from a recalled lot to continue taking their medicine until their doctor or pharmacist provides a replacement or offers a different treatment option.

This adds to the list of blood pressure medications recalled since October. 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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The US Food and Drug Administration is investigating several drugs used for controlling high blood pressure for possible cancer causing effect. The company said it hadn't received any reports of patients being harmed related to the recall.

"Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA".

A Bloomberg investigation found that an FDA inspector had raised concerns at the factory that made the valsartan in May 2017.

The FDA has said it thinks the potential carcinogens, known as nitrosamine impurities, are a result of the manufacturing processes the companies used. "The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future".

Since then, generic drugmakers such as Mylan NV, Teva Pharmaceutical and Novartis' Sandoz have recalled products containing the tainted ingredients.


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