Health Care

FDA recalls another blood pressure medication over concerns of cancer-causing ingredients

FDA recalls another blood pressure medication over concerns of cancer-causing ingredients”

Almost 90 lots of Losartan potassium tablets made by Hetero Labs in India and distributed by Camber Pharmaceuticals were recalled Thursday due the discovery of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a probable carcinogen.

That is after trace amounts of a potential carcinogen were found in the medicine.

The recalls began past year after regulators said ingredients used by Chinese manufacturer Zhejiang Huahai Pharmaceuticals Co to produce valsartan contained cancer-causing impurities.

Problems with potential cancer-causing agents in blood-pressure medications first cropped up in July, when an ARB called valsartan was recalled by Chinese drugmaker Zhejiang Huahai Pharmaceutical Co. Ltd.

The FDA said increased risk of cancer in patients exposed to the new impurity, NMBA, appeared to be the same as those exposed to NDMA, but less than the risk from NDEA.

This adds to the list of blood pressure medications recalled since October. That said, any presence of such impurities in drug products is not acceptable. 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.

"We are making important strides at understanding how these impurities form and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products", Gottlieb wrote. And that's what happened in the case of tainted ARBs. Other people are getting their prescriptions changed.

The FDA will continue to update the list of products included in the recall as more information becomes available from ongoing testing.

She hopes that in the next few years, technologies such as bar codes will be in place to help identify affected patients.

The agency's latest alert includes drugs that contain a potentially carcinogenic "impurity", though no adverse effects related to the recall have been reported.

Camber and Macleods are among the half dozen pharmaceutical firms that have recalled hypertension drugs found to contain possible carcinogens since early December.

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