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losartan 5 articles

Third cancer-causing impurity found in certain ARB blood pressure drugs

A third type of cancer-causing impurity has been found in a type of high blood pressure and heart failure medication from a class of drugs known as ARBs (angiotensin receptor blocker), the Food and Drug Administration (FDA) announced in a news release. The impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), was detected in losartan potassium tablets made by Hetero Labs Ltd., and distributed by Camber Pharmaceuticals. As a result, Hetero Labs recalled 87 lots of the pills in 25mg, 50mg, and 100mg dosages. Since last summer, the FDA has issued numerous recalls of the ARBs losartan, valsartan and irbesartan mainly due to the ... Read More

Camber recalls ARB losartan due to cancer causing impurity

Camber Pharmaceuticals Inc., is recalling 87 lots of its high blood pressure and heart failure medication losartan because the drug is contaminated with a potential human carcinogen. Camber is one of three companies to recall the drug lorsartan, and one of several to issue recalls involving high blood pressure drugs from a class known as ARBs, or angiotensin II receptor blockers. The recalled Camber products include losartan packaged in 30, 90, 500 and 1000-count bottles. A full list of Camber’s recalled losartan medications can be found on the company’s news release. The impurity detected in the drugs is called N-Nitroso ... Read More

More heart drugs recalled due to presence of cancer-causing impurity

Two lots of Torrent Pharmaceuticals Limited’s Losartan potassium tablets are the latest heart drugs to be recalled due to the presence of a probable human carcinogen called N-nitrosodiethylamine (NDEA). Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and for the treatment of nephropathy in type 2 diabetic patients. Patients currently taking Losartan should continue taking the medication because the risk of harm may be greater if the treatment is stopped abruptly without an alternative medication. Patients should contact their pharmacist or physician with concerns. Torrent’s recalled Losartan potassium tablets include Losartan Potassium Tab, USP, 100mg, 30-count ... Read More

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