FDA Issues List of 'Safe' Sartan-Containing Meds

April 05, 2019

The US Food and Drug Administration (FDA) has published a list of 40 medications containing angiotensin receptor blockers (ARBs) it has determined to be free of contamination from nitrosamines.

The list also includes ARB products for which the agency's testing process has yet to be completed but have not been recalled, and which "remain acceptable for distribution and for patient use," the agency has announced.

"For these ARBs, although our overall determination is still pending, at this time nitrosamine impurities either have not been detected or are below the interim acceptable intake limits."

ARBs and drug preparations containing them are widely used in heart failure, hypertension, and chronic kidney disease. But a long-running series of recalls involving nonproprietary formulations has led patients and clinicians into sometimes tough decisions about whether and how to continue using them.

The saga dates from July 2018, when then suspected carcinogen N-nitrosodimethylamine (NDMA) was detected in valsartan-containing products supplied by Zhejiang Huahai Pharmaceuticals (ZHP), Linhai, China.

"Removing the affected medications from the market has led to shortages," the FDA notes. "Currently, valsartan products are in shortage, and we know that other types of products have the potential to fall into shortage soon. In anticipation, the agency is not objecting to temporary distribution of specific lots of losartan that contain impurities above the interim acceptable intake limit, for a short period of time."

The potential benefit of treatment, it said, "far outweighs the low risk associated with continuing the medications with these impurities."

The agency's process for listing ARB-containing meds as cleared of nitrosamine taint considers "testing for impurities conducted by the FDA's laboratories, an evaluation of the manufacturing process used by multiple manufacturers of the active pharmaceutical ingredient found in ARB medicines, as well as other information available to the agency from manufacturers and international regulators," the agency said.

Statement from FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research on the agency's list of known nitrosamine-free valsartan and ARB class medicines, as part of agency's ongoing efforts to resolve ongoing safety issue. Issued April 4, 2019.

FDA's Assessment of Currently Marketed ARB drug products. Updated April 4, 2019.

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