NDMA


What it isNot a drug: a nitrosamine contaminant found in valsartan and other ARBs (2018), ranitidine and nizatidine, and metformin lots. FDA withdrew all ranitidine on 2020-04-01.
Why this oneCYP2E1 \u03b1-hydroxylation releases a methyldiazonium ion that methylates DNA (O\u2076-methylguanine): hepatotoxic and a probable human carcinogen.
What limits itFDA acceptable intake 96 ng/day. Forms by nitrosation of amines during synthesis or storage; ranitidine generates it on the shelf.
NO BOXED WARNINGS
Principal riskHepatotoxic; probable human carcinogen