Valsartan class action?

Understanding the Valsartan Class Action Lawsuit

The valsartan class action lawsuit centers around contamination of the popular blood pressure medication valsartan with a carcinogenic impurity called N-nitrosodimethylamine (NDMA).

Why Was Valsartan Contaminated with NDMA?

Valsartan was contaminated with NDMA due to changes in the manufacturing process at Chinese facilities owned by Zhejiang Huahai Pharmaceuticals [1]. The Chinese company began using a different chemical, called dimethylformamide (DMF), to make valsartan in 2013. However, the DMF was not properly removed during the manufacturing process, leading to the formation of NDMA.

What Did Regulators and Drug Manufacturers Know and When?

The U.S. Food and Drug Administration (FDA) was initially informed of the NDMA contamination in May 2018 by Zhejiang Huahai [2]. However, the FDA did not publicly disclose the issue until July 2018. Since then, the FDA has recalled numerous valsartan products from several manufacturers due to the presence of NDMA.

Class Action Lawsuits and Settlements

Multiple class action lawsuits have been filed against the manufacturers of valsartan, including Novartis, Teva Pharmaceuticals, and Mylan Pharmaceuticals [3][4][5]. These lawsuits claim that the companies failed to warn consumers and healthcare professionals about the potential risks of NDMA contamination. Some settlements have been reached in individual cases, but broader class action resolutions are still pending.

What to Do If You Took Valsartan Containing NDMA

Patients taking valsartan are advised to contact their healthcare provider about switching to a clean valsartan product or another medication. It is essential to report any concerns or questions about valsartan or NDMA contamination to the FDA's MedWatch program [6].

Sources:

[1] https://www.drugpatentwatch.com/drug/valsartan/

[2] https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-valsartan-angiotensin-ii-receptor-blokkade-valsartan-tablets

[3] https://www.msn.com/en-us/news/other/valsartan-lawsuit-novartis-ordered-to-pay-100m-settlement/ar-BBH7X2L

[4] https://www.themorningsun.com/localnews/teva-pharmaceuticals-agrees-to-settlement-over-valsartan-recall/articlec4bceba6-3c1c-5c43-9bb3-1e3d8f0a3a7f.html

[5] https://www.foxnews.com/health/teva-pharmaceuticals-valsartan-lawsuit-settlement

[6] https://www.fda.gov/medwatch/fda-mediwatch-voluntary-reporting-program