6 The International Agency for Research on Cancer (IARC) has on this basis classified NDMA as “probably carcinogenic to humans” (group 2A), emphasising that NDMA “should be regarded for practical purposes as if it were carcinogenic to humans.” 7 5 Although no in vivo data are available for humans, NDMA seems to be metabolised similarly in human tissue and rodent tissue. 4 NDMA is one of the most well characterised and most potent animal carcinogens known and has been shown to be a potent carcinogen across all species that have been investigated, both as single doses and with long term exposure to lower quantities. NDMA is the simplest dialkylnitrosamine and is known to be a by-product in various industries-for example, the manufacture of pesticides, rubber tyres, alkylamines, and dyes. Consequently, medical agencies across Europe as well as the US Food and Drug Administration have withdrawn all affected valsartan products from the market as of July 2018. 3 This contamination, which far exceeded regulatory exposure limits, was specific to drug products manufactured by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China, and seems to be related to a change in the manufacturing process that was implemented in 2012. 1 2 In July 2018, some valsartan products were discovered to have been contaminated with N-nitrosodimethylamine (NDMA). Valsartan is an angiotensin II receptor antagonist used to treat hypertension and heart failure.
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