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Valsartan 10 articles

Mylan expands blood pressure drug recall

Mylan Pharmaceuticals is expanding its recall of high blood pressure and heart failure treatments to include all its products that contain the active ingredient valsartan because they may contain trace amounts of a potentially cancer-causing impurity. The 104 additional lots involved in the recall include varying doses of 26 lots of amlodipine and valsartan tablets, 51 lots of valsartan tablets, and 27 lots of valsartan and hydrochlorothiazide tablets. The tablets were distributed nationwide from March 2017 to November 2018. A list of affected drugs can be found on Mylan’s recall notice. The impurity found in the drugs is N-nitrosodiethylamine (NDEA), ... Read More

Class action lawsuit filed over tainted blood pressure meds

A second class action lawsuit was filed against manufacturers and distributors of a high blood pressure drug that was found to be contaminated with a probable cancer-causing impurity. The lawsuit was filed in Boston federal court against New Jersey-based Camber Pharmaceuticals Inc., and Hetero Drugs Ltd. Hetero is based in India but makes the drug ingredient, valsartan, with its partner, Hetero USA Inc., also based in New Jersey. The lawsuit claims poor safety procedures at the India plant should have tipped the companies off years ago that the drugs could be contaminated. Instead, the companies “willfully ignored warning signs.” In ... 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

High levels of cancer-causing impurity found in heart drug valsartan

Levels of a carcinogenic impurity found in several brands of the high blood pressure and heart failure drugs containing the active ingredient valsartan are up to more than 2.5 times higher than what is considered “reasonably safe for human ingestion based on lifetime exposure,” according to a Food and Drug Administration (FDA) news release. The agency reported earlier that the impurity may have been present in some of the drugs for as long as four years. The impurity is called N-nitrosodimethylamine or NDMA. For reference, the FDA says that consuming up to 0.096 micrograms (mcg) of NDMA per day is ... Read More

Class action filed against makers, distributors of contaminated BP drug

A St. Louis man filed a class action lawsuit against a number of drug companies for manufacturing and distributing certain blood pressure and heart failure medications containing the active ingredient valsartan that may have been contaminated with a probable carcinogen. James Jones filed the lawsuit in the U.S. District Court for the Eastern District of Missouri two months after the Food and Drug Administration (FDA) informed the public about the issue and announced the first wave of recalls of drugs that contained valsartan. Companies named in the lawsuit are Zhejiang Huahai Pharmaceutical Co. Ltd., Prinston Pharmaceuticals, Solco Healthcare U.S. LLC, ... Read More

Second cancer-causing impurity found in valsartan heart drug

Another suspected cancer-causing impurity has been found in the high blood pressure and heart failure drug valsartan manufactured by Torrent Pharmaceuticals. The Food and Drug Administration (FDA) announced in July that several pills containing the drug ingredient valsartan by various manufacturers were being recalled because they were contaminated with an “unexpected impurity” called N-nitrosodimethylamine, or NDMA. The ingredient is considered a possible carcinogen by the Environmental Protection Agency (EPA). NDMA is an organic chemical byproduct of manufacturing some pesticides and processing fish, and can unintentionally make its way into manufacturing through certain chemical reactions. Not all valsartan-containing drugs are affected ... Read More

FDA expands recall of blood pressure drugs due to cancer-causing impurity

The list of blood pressure drugs recalled because they may contain a cancer-causing impurity has been expanded to include nearly five dozen products from 12 different pharmaceutical companies. On July 13, the Food and Drug Administration (FDA) first announced a recall of certain valsartan tablets because they were found to contain a chemical known a N-nitrocodimethylamine (NDMA) in levels that exceeded those considered acceptable for public safety. The chemical, which is sometimes found in water supplies and food, is classified by the Environmental Protection Agency (EPA) as a probable human carcinogen – something that can increase the risk of cancer ... Read More

Cancer-causing impurity may have been present in blood pressure drugs for years

The presence of a potentially cancer-causing impurity in some brands of the blood pressure and heart failure drug valsartan may have been present in the products for as long as four years, the Food and Drug Administration (FDA) announced in a Safety Alert and update about the agency’s ongoing investigation into drugs possibly tainted with N-nitrosodimethylamine, or NDMA. Last week, the FDA announced three recalls related to the NDMA impurity detected in the valsartan active pharmaceutical ingredient (API): Teva Pharmaceuticals USA labeled as Major Pharmaceuticals – recall at the retail level because these products are only used in facilities where ... Read More

Blood pressure meds contaminated with carcinogen recalled

Several brands of the high blood pressure and heart failure drug Valsartan nd Valsartan/Hydrochlorothiazide are being recalled because the medication is contaminated with trace amounts of a known human carcinogen called N-nitrosodimethylamine (NDMA). The presence of the impurity was unexpected and is thought to be related to changes in the way the active substance was manufactured. NDMA is classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC), an intergovernmental agency forming part of the World Health Organization of the United Nations. Studies have linked NDMA exposure to liver, respiratory tract, kidney and blood vessel tumors ... Read More