That burning feeling in your chest after you eat a heavy meal could be heartburn. Or it could be worry over the drugs you’ve taken to treat that heartburn. Among the top medical stories of 2019 was the discovery of contaminants in common medicines, and ranitidine—best known as Zantac—took up a large share of those headlines. A cancer-causing substance known as NDMA has been repeatedly found in one of the most popular drugs in the United States.
The scary news continues in 2020. On Wednesday, the Food and Drug Administration announced voluntary recalls of prescription forms of ranitidine by two generic drug companies, Appco Pharma and Northwind Pharmaceuticals, bringing the total number of ranitidine recalls to 14 in the past five months. The agency also reported that Mylan Pharmaceuticals recalled three lots of Nizatidine (Axid), a similar drug, again because of NDMA.
This week’s recalls are a new cause for alarm for the 15 million Americans who take ranitidine at prescription levels, and the millions more who regularly take lower-dose, over-the-counter versions. More than 60 million Americans experience heartburn at least once a month. Zantac was once the best-selling drug in the world.
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For people worried about past use of Zantac and cancer risk, here’s some back story and a bit of perspective.
Last year, Adam Clark-Joseph, cofounder of the mail order pharmacy Valisure, ordered ranitidine syrup, prescribed to treat reflux in his infant daughter. The pharmacy distinguishes itself by testing every batch of drugs 它的售价为杂质;此前，它已经发现了缬沙坦潜在的致癌物质，血压药。当雷尼替丁对NDMA检测呈阳性，valisure其他其他厂商的配方进行测试。 “每一批每一个制造商的每一瓶的显示了同样的结果，形成亚硝胺的巨大高，”首席执行官David光说。
Light says the findings point to an instability with the drug that, in the right conditions, could produce NDMA—for example, if heated. (Valisure heated its ranitidine to 130 degrees Celsius, or 266 degrees F. A car on a hot summer day could reach 140 F.) Valisure reported the results to the FDA, which took exception 在测试方法，测试其说，在较低温度下NDMA的用量要小得多已导致。不过，该机构回应了更大的问题，宣布九个;在9月与13只说明自愿召回这在雷尼替丁杂质样本“初期，有限的测试发现NDMA的不可接受的水平”。争辩说，它甚至作为“第三方实验室”使用方法“不适合用于测试雷尼替丁”，表示将更新它自己的调查（不加进热量）。
灯架由valisure的测试方法。 “我们使用这些条件来强调，这是从根本上不稳定的地步，”我说。进行的测试与存在valisure模拟胃液（在体温下，37摄氏度）和加入亚硝酸钠，模拟饮食随着加工肉类高水平常见防腐剂发现，并且发现了高水平的NDMA。亚硝酸盐是在创造NDMA的重要组成部分（第n）。 （有些蔬菜，熏鱼和乳制品目前硝酸盐和亚硝酸盐含）。