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Valsartan

The attorneys of Baldante & Rubenstein are representing individuals that took Valsartan, an anti-hypertensive medication, and developed cancer.

Valsartan sold under the trade name Diovan is a medication used to treat high blood pressure, heart failure, and diabetic kidney disease. In 2018, a leading manufacturer of generic Valsartan, Zhejiang HuaHai Pharmaceuticals Co. (ZHP), determined that some of their Valsartan was contaminated with NDMA (N-nitrosodimethylamine).  NDMA is a known carcinogen, and causes cancer in humans. On July 6, 2018, The European Medicines Agency (EMA) recalled certain batches of valsartan and valsartan/hydrochlorothiazide film-coated tablets distributed in 22 countries in Europe, plus Canada.  ZHP in Linhai, China manufactured the bulk ingredient contaminated with NDMA. On July 12, 2018, the National Agency of Drug and Food Control (NA-DFC or Badan POM Indonesia) announced voluntary recalls for two products containing valsartan produced by Actavis Indonesia and Dipa Pharmalab Intersains. On July 13, 2018, the U.S. Food and Drug Administration (FDA) announced voluntary recalls of certain supplies of valsartan and valsartan/hydrochlorothiazide in the U.S. distributed by Solco Healthcare, LLC, Major Pharmaceuticals, and Teva Pharmaceutical Industries.  Hong Kong’s Department of Health initiated a similar recall. On August 2, 2018, the FDA published two lengthy, updated lists, classifying hundreds of specific U.S. products containing valsartan into those included versus excluded from the recall. In September 2018, the FDA announced that retesting of all valsartan supplies had found a second carcinogenic impurity, N-nitrosodiethylamine (NDEA), in the recalled products made by ZHP in China and marketed in the U.S. under the Torrent Pharmaceuticals (India) brand. According to a 2018 Reuters analysis of national medicines agencies’ records, more than 50 companies around the world have recalled valsartan mono-preparations or combination products manufactured from the tainted valsartan ingredient. The contamination has likely been present since 2012 when the manufacturing process was changed and approved by the European Directorate for the Quality of Medicine (EDQM) and FDA authorities.   The FDA’s statement of July 13, 2018 stated: “The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”

If you or a loved one who took Valsartan and was diagnosed with cancer, please immediately call the attorneys of Baldante & Rubenstein so that we can provide a timely free consultation for you, properly investigate your claim, and obtain justice for you from the responsible party.

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