FDA Analysis Addresses ARB Impurity Risk to Patients – APhA submits compounding comments to FDA. – (866) 348-2889.
A recent analysis of N-Nitrosodimethylamine (NDMA) impurities has found the risk to patients appears to be small. The analysis, which was conducted by the FDA, was based on the maximum possible exposure.1
The analysis followed a series of recalls for some generic versions of angiotensin II receptor blocker (ARB) medicines containing nitrosamine impurities that do not meet the FDA’s safety standards. Used to treat high blood pressure and heart failure, the recalled ARBs include valsartan, irbesartan, and losartan.1