Potential for Angiotensin II Receptor Blocker Shortages
January 25, 2019 – According to the U.S. FDA, recalls of angiotensin II receptor blockers (ARBs), or “sartan” drugs, could lead to new shortages of blood pressure medications in the United States. Various manufacturers have recalled certain valsartan, losartan, and irbesartan products since the summer of 2018 due to impurities likely created by the manufacturing process.
The FDA currently reports a valsartan shortage following recalls due to the presence of N-Nitrosodimethylamine (NDMA) and/or N-Nitrosodiethylamine (NDEA) in various valsartan-containing products. Valsartan was the first ARB to be recalled due to the presence of NDMA impurities in 2018, with recalls later affecting valsartan and other drugs due to NDEA. Both NDMA and NDEA are considered probable human carcinogens, or cancer-causing agents.
Although the FDA believes the risk to patients from these substances is low, it has set interim limits on NDMA and NDEA in “sartan” drugs. It has also published guidelines for manufacturers on testing for the substances in their products. Patients who may be taking a recalled ARB should continue taking the medication until they receive a replacement or have switched to an alternative therapy under the guidance of their healthcare provided. Stopping treatment could put patients at risk.
The FDA believes that NDMA and NDEA may be created when certain chemicals and reaction conditions are present in the ARB manufacturing process. The reuse of solvents in manufacturing may also play a role. Investigations into the source of the impurities are ongoing.