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A second carcinogen was discovered in the blood pressure and heart failure medication, valsartan. The FDA issued a recall in July 2018 when some batches of valsartan were found to contain N- Nitrosodimethylamine (NDMA), a known carcinogen. Recently, however, the FDA announced the presence of a second carcinogen in valsartan, N-Nitrosodiethylamine (NDEA). NDEA is proven to cause cancer in animals, and is likely a human carcinogen as well.

Prolonged exposure to these carcinogens can cause a variety of health problems including:

  • Acute liver injury (requiring a hospital visit)
  • Liver cancer
  • Kidney cancer
  • Lung cancer

NDEA and NDMA can be accidentally produced through chemical reactions that take place during the manufacturing process, which is likely how they wound up in valsartan. A chinese manufacturing company that produces the active ingredient in valsartan, Zhejiang Huahai Pharmaceuticals, is at the center of the recall. The FDA visited their manufacturing plant and uncovered issues with the company’s manufacturing process. As a result, the FDA put the company on an import alert, which prevents all imports of their medication ingredients from legally entering the United States. This import alert will last until it can be determined exactly how these carcinogens were formed.

The FDA is currently investigating the cause of these impurities and is continuing to test products to ensure that they are not contaminated with the carcinogens. They are also working to learn more about NDMA and NDEA and the potential health consequences they may cause.

The FDA further expanded their list of recalled valsartan product after they discovered the second impurity. While not all valsartan medications were contaminated, so far over a dozen brands of valsartan have been recalled. For a full list and the latest updates, please visit the FDA’s website. If your medication is among those listed, you should immediately contact your doctor before you stop taking valsartan.

If you or your loved one took valsartan and developed an illness as a result, call the Law Offices of Rudolph F.X. Migliore. These types of lawsuits put victims in a vulnerable position, and we want to help. We are your point of contact during the legal process and we are with you every step of the way. Call our Long Island office at 631-543-3663 to schedule a free consultation.