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irbesartan 3 articles

FDA updates consumers on tainted heart drugs investigation

The Food and Drug Administration (FDA) issued a warning letter to the China-based manufacturer of the active pharmaceutical ingredient (API) in the heart medication valsartan that is under investigation by the agency after the presence of a probable cancer-causing impurity was found in the drugs. The FDA’s warning letter outlines several manufacturing violations at Zhejiang Huahai Pharmaceutical Co. Ltd (ZHP), in Linhai, Taizhou Zhejiang China, including impurity control, change control and cross contamination from one manufacturing process line to another. The FDA is still looking for the root cause of the impurity, which the agency said previously may have been ... Read More

Third hypertension drug found to contain probable carcinogen

A third medication for high blood pressure has been found to contain trace amounts of a suspected cancer-causing agent, prompting another recall. This time, Sandoz Inc., recalled one lot of losartan potassium hydrochlorothiazide tablets after trace amounts of the impurity N-nitrosodiethylamine (NDEA) was detected. The active pharmaceutical ingredient losartan was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz’s losartan potassium hydrochlorothiazide is manufactured by Lek Pharmaceuticals dd, Ljubijana, Slovenia. NDEA is classified as a probable human carcinogen by the World Health Organization’s International Agency for Research on Cancer (IARC). Losartan potassium hydrochlorothiazide tablets are used to treat hypertension. The drug ... Read More

Another heart drug recalled due to presence of cancer-causing agent

Another medication used to treat hypertension is being recalled after it was found to be contaminated with a suspected cancer-causing agent, the Food and Drug Administration (FDA) announced in a Safety Communication. Manufacturer ScieGen is recalling certain lots of the heart drug irbesartan. Affected products have printed on their labels the words “Westminster Pharmaceuticals” and “GSMS Inc.” The announcement comes on the heels of a recall of several lots of the high blood pressure and heart failure medication valsartan. Both irbesartan and valsartan are in a class of heart drugs called angiotensin II receptor blockers, or ARBs. And both were ... Read More