Gov't Bans Sale of 59 Blood Pressure Drugs Containing Probable Carcinogen

The FDA has a running list of heart medications that could contain a cancer-causing substance as well as a list of drugs that are not recalled

N-Nitrosodimethylamine (NDMA), a carcinogen, was detected in locally produced antihypertensive medicines containing valsartan, and 59 items were suspended for manufacturing and sales. Ltd. The valsartan was not used in the manufacture of drugs.

"Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years".

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Last month, the FDA issued a voluntary recall of certain batches of the drug valsartan, which is used to treat high blood pressure and heart failure. "This assessment led to FDA's decision to have these batches recalled", the agency said.

The agency said the presence of NDMA in medications was possibly related to changes in valsartan manufacturing.

"FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients (APIs) are not at risk of NDMA formation". With a reported 45% market share, the Huahai API turned up in many generic products.

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It has been revealed that two more companies have supplied valsartan that was tainted with a cancer-causing impurity, extending a scandal that prompted global recalls of blood-pressure drugs that use the chemical.

All the USA products were pulled from shelves on July 16.

Other products that recorded more than 1 billion won of total sales a year ago include JW Pharmaceutical's Valsaforce (3.71 billion won), Aju Pharmaceutical's Anafurge (1.57 billion won), Myungmoon Pharmaceutical's Exnin (1.12 billion won) and Daehwa Pharmaceutical's Varoforge (1.01 billion won).

Not all valsartan-containing medications have been recalled, however, and those also are listed on the FDA's website.

The FDA said patients with the recalled products should contact their doctor and their pharmacist if their medication is included on the recall list.

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