FDA Provides Update on Ongoing Investigation Into Valsartan Products
Impurities likely resulted because of certain chemicals and reaction conditions during the manufacturing process of the API.
The Food and Drug Administration (FDA) has issued a statement regarding the ongoing investigation into potentially carcinogenic impurities identified in some angiotensin II receptor blockers (ARBs).
In the summer of 2018, the FDA learned that some generic ARB medications, including valsartan, irbesartan, losartan and others contained nitrosamine impurities— including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)—posing a potential safety concern. Subsequently, the Agency announced a series of recalls of products that contained these impurities above an acceptable level.
"Our analysis of NDMA found that the risk to patients based on the maximum possible exposure appears to be small. That doesn't diminish our concern and our determination to find out how these impurities occurred in the first instance. [...] Our ultimate goal is to ensure that these impurities are not present in finished drug products, or their components (including active pharmaceutical ingredients, or API)," stated FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research.
While still ongoing, the FDA investigation revealed that the impurities likely resulted because of certain chemicals and reaction conditions during the manufacturing process of the API. In addition, these impurities may be generated from reused materials such as solvents. "Through our investigation, we're working to ensure that other manufacturing conditions don't contribute to NDMA, NDEA, or related impurities in finished drug products," they added.
Information on the ongoing recalls can be found here.