Published: Wed, July 18, 2018
Medicine | By Douglas Stevenson

FDA Recalls Heart Medications Containing the Active Ingredient Valsartan

FDA Recalls Heart Medications Containing the Active Ingredient Valsartan

The Food and Drug Administration announced a voluntary recall of a widely prescribed blood pressure medication made in China, reviving fears about the safety of imported drugs.

Some drugs containing the active ingredient valsartan may contain N-nitrosodimethylamine, which is classified as a probable human carcinogen based on results from laboratory tests.

The FDA believes this sudden presence of NDMA is because of the way the substance was manufactured.

Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product. "As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients' therapeutic needs are met in the United States with an adequate supply of unaffected medications".

If you don't know where you medication came from in the past, your pharmacy should have that information.

The Ministry of Health and Wellness will continue to follow warnings from the global regulatory agencies with respect to any changes in pharmaceutical products to continue to ensure the availability of safe and quality products to the public. This information will be posted to the FDA's website.

If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company.

Overall, more than two-thirds of all active drug ingredients originate in China and India, industry experts estimate, with China accounting for the lion's share. The drugs have been distributed by Major Pharmaceuticals, Teva Pharmaceutical Industries and Solco Healthcare, according to the FDA.

A listed Chinese pharmaceutical firm that makes and sells generic drugs to the global market including the United States and Europe, has recalled some of its products after finding that they may have been tainted by a cancer-causing substance.

In Europe and Asia, Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan/HCT film-coated tablets are being recalled because they "do not meet our high quality standards". "That is why we've asked these companies to take immediate action to protect patients".

Impacted medication includes, "40 mg, 80mg, 160mg, and 320mg; and Valsartan-HCTZ Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg, within expiration dates from July 2018 to January 2020", according to a statement.

So far, neither Prinston Pharmaceutical, Major Pharmaceuticals, nor Teva Pharmaceuticals has received any reports of adverse reactions to the recalled products.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

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