Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications | FDA

Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications | FDA

Statement from Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the agency’s ongoing efforts to resolve safety issue with ARB medications

products the agency approves. The recent Angiotensin II Receptor Blocker (ARB) recalls have deeply concerned patients, the medical community, the agency and international regulatory bodies. The FDA is aware many patients rely on ARB medicines, and we are concerned about the presence of nitrosamine impurities in these drugs. Millions of people benefit from the high-quality products that the FDA regulates, and the U.S. has the most robust drug supply in the world, with strict standards for safety, effectiveness and quality. Clarifying the risk and scope of exposure As part of our efforts to be transparent regarding impurities in ARBs, we want to make sure patients have a full understanding of how these impurities may affect them. Notably, we would like to stress that the actual risk to patients is likely much lower than our estimates, which reflect a scientific assessment of the highest possible exposure. We initially estimated that if 8,000 people took the highest valsartan dose (320 mg) containing N-Nitrosodimethylamine (NDMA) from the recalled batches daily for four years, there may be one additional case of...

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