What is Valsartan?
Valsartan is an angiotensin II receptor blocker (ARB) medicine that is widely used to treat high blood pressure (hypertension) and heart failure. It can also be prescribed after a heart attack.1
What is the Issue with Valsartan?
Beginning the summer of 2018, the Food and Drug Administration (FDA) learned and reported that some generic versions of the ARB medicines contain impurities that did not meet the agency’s safety standards. The impurities found in some Valsartan lots include NDMA and NDEA, which are probable human carcinogens, and NMBA, a potential human carcinogen, respectively, based on the classifications of the International Agency for Research on Cancer (IARC). In august, the FDA updated their list of recalled medications, and currently, it included not only Valsartan but also Losartan and Irbesartan.
There were a number of pharmaceutical companies involved in this incident, namely, Teva Pharmaceuticals, Solco Healthcare, Major Healthcare, etc. Zhejiang Huahai Pharmaceuticals (ZHP), which is located in China, was the main manufacturer and supplier of these companies.
During the investigation, the FDA learned that ZHP was not adhering to the procedures in ensuring that their medicines meet the safety standards, and according to FDA Commissioner Scott Gottlieb, M.D.3, “these violations reveal a disturbing lack of oversight at this API manufacturer that puts patients at risk.” For this reason, the FDA issued a warning letter to ZHP. The issues cited in the letter are associated with the presence of nitrosamine in their drugs.
The cases have been consolidated in the MDL 2875 In Re: VALSARTAN, LOSARTAN, AND IRBESARTAN PRODUCTS LIABILITY LITIGATION, taking place in the District of New Jersey. 4
Hon. Robert B. Kugler, U.S.D.J.
Hon. Joel Schneider, U.S.M.J.
As of June 15th, the total number of pending cases in the MDL was 1,110.
1. NHS (N.D) https://www.nhs.uk/medicines/valsartan/about-valsartan/
2. U.S. Food & Drug. (July 13, 2018). FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-several-medicines-containing-valsartan-following-detection-impurity
3. U.S. Food & Drug. (December 11, 2018). FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications https://www.fda.gov/news-events/press-announcements/fda-warns-api-manufacturer-involved-valsartan-recall-provides-information-patients-taking-these
4. United States District Court District of New Jersey https://www.njd.uscourts.gov/valsartan-mdl-2875