Valsartan Lawsuit

Valsartan is a medication used to lower high blood pressure, treat and manage congestive heart failure, and improve survivability after a heart attack. It belongs to a group of antihypertensive drugs called angiotensin II receptor blockers (ARBs).

The FDA approved the Novartis’ branded and patented version of Valsartan, Diovan, in 2002. Novartis’ patent expired in 2012, and many generic drug manufacturers have since produced and sold the drug.

Brand names for drugs containing Valsartan include Diovan, Prexxartan, Amlodipine, Exforge, Entresto, and Byvalson.

Valsartan works by inhibiting the binding of angiotensin II to angiotensin receptors. This effectively stops angiotensin activity and relaxes blood vessels to decrease vascular resistance and blood pressure. It also inhibits aldosterone secretion, which inhibits sodium and water reabsorption in the kidneys.

An update was released in September 2018 stating that additional unexpected impurities had been found in Torrent Pharmaceuticals’ valsartan products. N-Nitrosodiethylamine (NDEA), a known animal and suspected human carcinogen, was found in three lots of the drug.

In October 2018, the FDA released the laboratory analysis of generic valsartan products from different pharmaceutical companies. It is estimated that 1 out of 8,000 patients who took the highest valsartan dose containing NDMA could develop cancer.

In November 2018, Teva Pharmaceuticals announced a nationwide recall of many of its valsartan product due to NDEA impurities. In December 2018, Mylan Pharmaceuticals also announced a recall of all of its valsartan-containing products.

For a current list of valsartan-containing products under recall, please click here. As of December 2018, the recall includes valsartan-containing products from the following companies:

• A-S Medication Solutions LLC
• AvKARE
• Bryant Ranch Prepack Inc.
• Camber Pharmaceuticals
• HJ Harkins Company Inc. (Pharma Pac)
• Northwind Pharmaceuticals
• NuCare Pharmaceuticals
• Preferred Pharmaceuticals
• Prinston Pharmaceutical Inc., including its subsidiary Solco Healthcare LLC
• Proficient Rx LP
• RemedyRepack Inc.
• Teva Pharmaceuticals, including its subsidiaries Major Pharmaceuticals and Actavis
• Torrent Pharmaceuticals Limited

NDMA is a volatile, combustible chemical compound that is primarily used in laboratories to induce tumors in animals for research. Eye and skin irritation and liver damage can be experienced due to NDMA exposure. It is usually a food and water contaminant, and was first noticed as a groundwater contaminant in California near sites of rocket fuel production. It is considered a probable carcinogen among humans by the Environmental Protection Agency (EPA).

Meanwhile, NDEA is a water-soluble, volatile oil also used to induce liver tumors in experimental research. It is also used as a gas and lubricant additive, antioxidant, and a stabilizing agent for industrial materials. It is also a probable carcinogen, and is one of the most potent carcinogens among the nitrosamines group.

A study in September 2018 from the British Medical Journal performed an assessment of cancer risk and NDMA contaminated valsartan. Participants included a total of 5,150 Danish patients aged 40 and above, using or initiating valsartan use between January 2012 to June 2017, and without any history of cancer.

Out of 3,625 patients who were not exposed to NDMA, 104 developed cancer. 198 out of 3,450 participants exposed to NDMA were diagnosed with cancer later on. Increased risk for colorectal and uterine cancer was also observed for single cancer outcomes. The study concluded that the results do not imply a markedly increased short-term overall risk of cancer among valsartan users, but suggests studies with longer follow-up.

If you or your loved one suffered from cancer or developed tumors from taking valsartan, Maxwell Law Group can help get you the compensation you deserve. Call (844) 525-7155 or fill out the form below and we’ll investigate your case at no charge to you.