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Valsartan 16 articles

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