FDA Drug Recall: Blood Pressure & Heart Medications

In mid-July the U.S. Food and Drug Administration notified healthcare professionals and patients taking certain generic blood pressure medications containing the drug valsartan of a FDA Drug Recall. The dangerous drug recall was issued after the agency discovered impurities of N-nitrosodimethylamine. NDMA has been classified as a probable human carcinogen and cancer-causing agent. The three major pharmaceutical companies identified in the sales and distribution of recalled lots of valsartan and valsartan-combination drugs have agreed to a voluntary product recall.

 Consumers can visit the FDA website for drug recall instructions. You can match the name of the drug and company listed on your prescription label to determine if your medication is affected by the recall. Since these heart medications are used to treat and manage serious medical conditions like high blood pressure or heart failure, patients are advised “Do Not Stop Taking Medication” without first consulting a physician. You doctor and pharmacist can provide important information about your alternatives, such as a different medication or simply another valsartan product.

Remember, the drug valsartan is not the problem. So, patients should not lose faith in taking the blood pressure medication as prescribed. All medications named in the FDA drug recall are generic versions of the brand name Diovan, which is made by Novartis International AG. Brand name versions of Diovan as well as other generic valsartan heart medicines from other manufacturers are not included in the recall. In an announcement from the FDA’s Center for Drug Evaluation and Research, it was explained that the recalled medical products failed the FDA’s current safety standard test for contaminants. The medications being recalled are all linked to the same Chinese pharmaceutical manufacturer, Zhejiang Huahai Pharmaceutical.

NOTE: Consumers are asked to report adverse reactions and other health-related issues to the FDA through the U.S. Food and Drug Administration’s MedWatch Adverse Event Reporting program.

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