Specific to losartan products, N-Methylnitrosobutyric acid (NMBA) has been found in certain manufacturers’ products. Other ARBs have been found to have different but similar nitrosamines: N-nitrosodiethylamine (NDEA) and N-Nitrosodimethylamine (NDMA). All of these nitrosamine impurities, in levels above acceptable limits, are known to be carcinogenic to animals and humans.  The FDA has stated that at the levels detected, risk is “very low.” Nevertheless, they stated they are concerned and continue to investigate why such contamination is occurring. At this time, it is believed that the nitrosamines are being formed when specific chemicals and reactions are combined during the manufacturing of the ARBs. Additionally, it is believed that the reuse of some of the chemical materials (i.e. solvents) used during the process may be leading to the higher formation of nitrosamines.  The FDA has advised patients that they should not stop taking their ARB (even if from an affected lot) without speaking to their doctor or pharmacist so that an alternative therapy plan can first be made. The FDA further goes on to remind providers and patients that not all ARBs contain the contaminants. The best way patients can find out more information on whether they were given a recalled ARB would be to have them contact their pharmacist for specific information.

To learn more information, including links detailing all ARBs/manufacturers that have been part of the recall, click here:  https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm .  For more information specific to the losartan recall, click here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632425.htm.