Blood Pressure Medicine Recalls Expanded Due to Presence of Nitrosamines

Since July 2018 numerous batches of heart medications contaminated with known probable carcinogenic compounds have been reported. The initial recall of the blood pressure medicine valsartan has since expanded to also include the medicines losartan and irbesartan. The cause for concern and ultimately for recalling these medicines stems from the detection of known probable carcinogens N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). Recently, the related compound, N-nitroso-N-methyl-4-aminobutryic acid (NMBA), was also detected in losartan and irbesartan, sparking new recalls of those medicines. More information regarding the recall timeline and status can be found on the US FDA’s website, as accessed here. 

CIL has offered native and isotopically labeled standards for nitrosamine analysis for many years. With the recent contamination events, we have been working diligently to maintain inventory of these important standards to assist various agencies with their testing needs. CIL is currently working on new native and isotopically labeled NMBA standards to help with analytical quantitation of this compound. Please contact your CIL representative for more information.

Nitrosamines

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CIL, and Terry Grim in particular, would like to recognize the late Gaydie Connolly, who began her career as a chemist in the 1960s and unfortunately passed away 20 years ago after a long battle with cancer. Gaydie brought to our attention the idea of producing quantitative standard solutions prepared at relatively low concentrations as a way to drastically reduce analytical chemists’ exposure to toxic chemicals, and as a result thousands of chemists have been able to use CIL products at greatly reduced risks of chemical exposure to compounds like NDMA (the compound she found particularly worth avoiding), pesticides, and chemicals that over the years have been associated with increased occurrences of cancer, endocrine disruption and other human health effects we are just beginning to understand.