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FDA Finds Another Carcinogen In Valsartan

  • September 25, 2018
  • KBA Attorneys
  • No Comments

The Food and Drug Administration announced that it has found another possible cancer-causing ingredient in valsartan products sold by Torrent Pharmaceuticals.

The impurity found is NDEA, a known animal and suspected human carcinogen. The FDA reports, “The FDA and the European Medicines Agency have learned that Zhejiang Huahai Pharmaceuticals (ZHP) found NDEA in several batches of its valsartan API. The FDA immediately began retesting all valsartan API and products, including both recalled products and those currently marketed in the United States, for NDEA.”

This is the second type of carcinogen found in lots of valsartan. As we reported back in July, Torrent Pharmaceuticals Limited voluntarily recalled 14 lots of Valsartan / Amlodipine / HCTZ Tablets. These products were found to contain the impurity NDMA, or N-nitrosodimethylamine. This substance is often found in water, air pollution and certain foods.

The Food and Drug Administration is continuing to test all valsartan products, and we will update you if there are any new impurities found.
Signs and symptoms of NDMA over-exposure include:
• Headache
• Fever
• Nausea
• Jaundice
• Vomiting
• Abdominal Cramps
• Enlarged Liver
• Dizziness
• Reduced function of liver, kidneys, and lungs

What is Valsartan?

Valsartan is an active ingredient in various medications, both prescription and generic, used to treat high blood pressure, heart failure, and other cardiovascular issues. Valsartan is also routinely prescribed in conjunction with hydrochlorothiazide (HCTZ) to treat hypertension. An estimated 3 to 3.7 million patients have been prescribed medications that contain valsartan.