Valsartan Cancer Risk

The drug Valsartan (a generic version of Diovan), which is prescribed to treat high blood pressure and prevent heart failure, has been recalled worldwide after it was found to contain N-nitrosodimethylamine (NDMA), a known carcinogen. Valsartan contamination from a Chinese manufacturing plant may date back to 2012, potentially exposing many patients to Valsartan cancer risk, liver damage and tumors. It has been on the market for 15 years.

NDMA, or N-nitrosodimethylamine, is a chemical used in rocket fuel and it is classified as a carcinogen. Short-term exposure to toxic NDMA can cause liver damage while long-term exposure can increase the risk of liver, kidney, and lung tumors. Investigators found that NDMA had contaminated Valsartan’s production at Zhejiang Huahai Pharmaceuticals in Linhai, China, possibly since 2012 when the company changed its manufacturing process and produced NDMA as a by-product.

The FDA recall on July 17 involves medicines from: Solco Healthcare, Major Pharmaceuticals, and Teva. Valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc. are labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack, according to the FDA. Two of these companies, A-S Medication and RemedyRepack, may also distribute valsartan products not affected by the recall.

The following additional re-packagers are recalling or are expected to recall valsartan-containing products:

• H. J. Harkins Company Inc. (this company was not originally included on either list)
• Lake Erie Medical, doing business as Quality Care Products LLC
• NuCare Pharmaceuticals Inc.
• Northwind Pharmaceuticals
• Proficient Rx
• Bryant Ranch Prepack Inc.

The FDA approved Valsartan as a treatment for high blood pressure, or hypertension, in adults and children age six and up. It’s also approved for use in adults to treat heart failure and to reduce the risk of death in patients who recently had a heart attack. Valsartan is in a class of hypertension medications known as angiotensin II receptor agonists that reduce the constriction of blood vessels so that blood flows more freely. Valsartan is a stand-alone medication or valsartan HCTZ, which combines valsartan with the diuretic hydrochlorothiazide.

Valsartan lawsuits allege the medication can be tainted with N-nitrosodimethylamine (NDMA), a known cancer-causing substance. Attorneys are investigating claims from clients who took valsartan and have been diagnosed with liver damage, tumors, or lung cancer.

A proposed national class action has begun in Canada on behalf of all Canadians who purchased or ingested one or more of the valsartan medications which have been recalled, according to the CBC. The plaintiff claims that five pharmaceutical companies who supplied contaminated valsartan nationwide were negligent in their manufacturing of the drugs and in their failure to implement appropriate quality control testing when they received raw material from their supplier in China. The five defendants in the proposed Valsartan class action lawsuit are Teva Canada Limited, Sandoz Canada Inc., Pro Doc Limitee, Sanis Health Inc., and Sivem Pharmaceuticals ULC.

According to Radio Canada International,(July 18, 2018) the five pharmaceutical companies involved have so far not released information on the levels of contaminant, nor the number of years the chemical was in their products, nor what the potential health implications are. One Canadian attorney said the requests for a class-action suit already have over a thousand applicants, and he expects tens of thousands more--the recall could impact 4.4 million Canadians who have been prescribed these drugs.

“The recall is huge, based on the volume and the large number of patients it could have impacted,” John Brito, of the market research firm Fore Pharma told the New York Times(July 16, 2018). If you developed cancer or liver damage after taking the medication, you may have a legal claim against Valsartan manufacturers.

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Published on Jul-31-18