Thursday, August 30, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings


Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one medication, valsartan, contain an impurity that doesn’t meet FDA’s safety standards. Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The FDA currently has a major operation underway to investigate and address this troubling finding. This investigation is led by a dedicated task force of experts focused solely on this important work. Their mandate is to oversee the investigation and track new developments and information coming in from valsartan manufacturers. This multidisciplinary team of chemists, toxicologists, medical doctors, pharmacists, investigators, communication specialists, and analytical lab staff coordinates across the FDA, and acts on the newest available information.

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