Third Potential Carcinogen Found in Blood-Pressure Drugs

Third Potential Carcinogen Found in Blood-Pressure Drugs

Third Potential Carcinogen Found in Blood-Pressure Drugs

There have been higher than a dozen recollects of variations of the blood stress and coronary heart drugs losartan, valsartan, and irbesartan that contained hint quantities of possible carcinogens.

The remedy is packaged in 30 rely upon, 90 depend, 500 depend and 1000 rely on bottles. Prinston Pharmaceutical identified China's Zhejiang Huahai Pharmaceuticals as the source of NDEA found in its hypertension medication recalled by the company last month. The active ingredient in each came from India-based Hetero Labs Limited.

On Thursday, the FDA announced Camber Pharmaceuticals is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg and 100 mg because N-Nitroso N-Methyl 4-amino butyric acid (NMBA) - a "potential human carcinogen" - was detected in a pharmaceutical ingredient of the product.

The Food and Drug Administration has expanded an already widespread recall of common blood pressure and heart failure medications.

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A series of drugs have been identified as potentially risky since an initial recall began seven months ago.

Gottlieb said the agency is "deeply concerned about the presence of a third nitrosamine impurity" in hypertension drugs and is working on "novel and sophisticated testing methods" to detect these impurities. The recalled products vary in dosage from 40 mg to 320 mg, and have expiration dates that range from October 2019 to July 2020.

"We're continuing to share these testing methods with global regulators, industry and the public to help manufacturers and other regulators evaluate these products for any potential nitrosamine impurity". Hetero also makes valsartan that was recalled for containing NDMA. "The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future".

The agency said on its site: "Not all ARB products contain NDMA, NDEA or NMBA impurities, so pharmacists may be able to provide an alternative medication not affected by the recalls, or health care professionals may prescribe a different medication that treats the same condition".

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