GESTIÓN EN SALUD PÚBLICA: Statement from FDA’s Center for Drug Evaluation and Research Director Janet Woodcock, M.D., alerting patients and health care professionals of NDMA found in samples of ranitidine

sábado, 14 de septiembre de 2019

Statement from FDA’s Center for Drug Evaluation and Research Director Janet Woodcock, M.D., alerting patients and health care professionals of NDMA found in samples of ranitidine

https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine?utm_campaign=091319_Statement_FDA%20alert%20of%20NDMA%20found%20in%20some%20raniditine%20medicines&utm_medium=email&utm_source=Eloqua

Statement from FDA’s Center for Drug Evaluation and Research Director Janet Woodcock, M.D., alerting patients and health care professionals of NDMA found in samples of ranitidine

The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the...