The U.S. Food and Drug Administration has announced a recall of several drugs that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure. There has been an impurity found in valsartan called N-nitrosodimethylamine (NDMA).
Officials say NDMA is a probable human carcinogen, or something that could cause cancer, and is believed to be related to how the products were manufactured.
According to the FDA, the presence of NDMA is these drugs was unexpected.
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The recall doesn't include all products containing valsartan; valsartan medications made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. are being recalled, along with valsartan/hydrochlorothiazide (HCTZ) from Solco Healthcare and Teva Pharmaceuticals Industries Ltd. "This is why we've asked these companies to take immediate action to protect patients", explained Janet Woodcock, director of FDA's Center for Drug Evaluation and Research. The DRAP Recall alert stated that a total of nine pharmaceutical companies in Pakistan are on the DRAP recall list and this list does not include Getz Pharma and its products: Cova, Covam and Cova-H.
To determine if a specific product has been recalled, look at the drug name and company name on the prescription bottle's label.
-Valsartan, manufactured by Teva Pharmaceuticals Industries Ltd.
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The FDA continues to review this situation and is investigating possible effects on patients taking these drugs and how companies can reduce or eliminate NDMA in future batches of medication.
Not all medications containing valsartan were included in FDA's recall.
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