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FDA expands recall of blood pressure drugs over cancer-causing risks

FDA expands recall of blood pressure drugs over cancer-causing risks The U.S. Food and Drug Administration has expanded the recall of valsar...

FDA expands recall of blood pressure drugs over cancer-causing risks

The U.S. Food and Drug Administration has expanded the recall of valsartan-containing high-blood pressure and heart failure drugs due to the risk some could contain a substance that increases the chances of developing cancer.

In its latest update, the FDA says it expanded the list of products affected under the recall and even some valsartan-containing products that are unaffected. For a full list of those affected, click here, and for a list of those unaffected by the recall click here.

The expanded recall includes products under the Camber Pharmaceuticals Inc. label, although "not all Camber valsartan products distributed in the U.S. are being recalled." Last week, the New Jersey-based company announced a voluntary recall of all unexpired Valsartan Tablets sent to hospitals, retail centers and mail-order customers.

"Camber Pharmaceuticals is recall ing certain valsartan tablets because they contain the impurity N-nitrosodimethylamine in the active pharmaceutical ingredient (API)," the FDA reports. "Test results from Hetero Labs show the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang.

"FDA is testing samples of valsartan API and finished products to confirm the extent and amount of NDMA and help inform the ongoing investigation."

The original recall for valsartan-containing drugs was announced a month ago on July 13 after tests revealed some products could be tainted with the carcinogen.

NDMA is classified as a likely human carcinogen -- a substance linked to causing cancer -- by an international cancer research agency. The substance was found in "multiple batches of Valsartan Tablets" that was manufactured by Hetero Labs Limited.

CNN reports that scienti sts with the FDA estimate that if 8,000 took 320 milligrams of affected valsartan-containing products each day for four years then addition person would develop cancer. Dr. Mary Ann Bauman of the American Heart Association told the outlet that patients should not stop taking their medication as that could cause harm, and that they should "definitely talk with your doctor first."

Anyone prescribed or currently taking valsartan-containing products are asked to contact their doctor for "further guidance and potential change of treatment before they stop taking this product." The FDA advises consumers to call 1-800-505-9291 or email recall@qualanex.com with any questions or concerns.

Source: Google News US Health | Netizen 24 United States

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