2019-03-19-FDA Recalls Losartan

2019-03-19  本文已影响0人  相思清狂

原文载于FORTUNE杂志:http://www.fortune.com/2019/03/15/tesla-model-y-suv/

FDA Recalls Losartan Lots, Another Blood Pressure Drug Contaminated With a Cancer Causing Impurity

By BRITTANY SHOOT March 18, 2019

原文 译文(机译+略改)
The United States Food and Drug Administration (FDA) has issued more recalls for the blood pressure medication losartan. 美国食品和药物管理局(FDA)发布了更多关于血压药物氯沙坦的召回。
The latest recall notices were issued on Friday as two separate, voluntary recalls, both being issued in conjunction with Missouri-based Legacy Pharmaceuticals Packaging, LLC. No adverse effects related to these recalled hypertension drugs have been reported. Lists of the impacted lots of losaratan potassium tablets included in these latest recalls can be found here and there. 最新的召回通知是在上周五发布的,是两起独立的自愿召回,都是与总部位于密苏里州的遗留药品包装一起发布的。没有与这些召回的高血压药物相关的不良反应的报告。在最近的召回事件中受影响的氯萨拉坦钾片的清单随处可见。
As with the multitude of other blood pressure medication recalls that have piled up since 2018, these two recalls are due to a cancer-causing impurity found in trace amounts in the recalled lots of losartan. In these recalls, the chemical found was N-Nitroso N-Methyl 4-amino butyric acid (NMBA), which is listed as a potential human carcinogen. NMBA is the third type of carcinogen found in blood pressure medications that were then recalled. 自2018年以来,大量其他降压药召回事件层出不穷,这两起召回事件都是由于在召回的大量氯沙坦中发现了微量致癌杂质。在这些召回中,发现的化学物质是N-亚硝基N-甲基4-氨基丁酸(NMBA),它被列为一种潜在的人类致癌物。NMBA是在随后被召回的降压药中发现的第三种致癌物质。
These recalls are bad business for everyone, not just impacted consumers. In February, the House Energy and Commerce Committee wrote to now-outgoing FDA commissioner Scott Gottlieb to inquire about inspections at overseas drug packaging plants. At least a dozen cardiovascular drugs have been recalled recently, including types of amlopidine, irbesartan, and valsartan. 这些召回事件对所有人来说都是件坏事,不仅仅影响到消费者。今年2月,众议院能源和商务委员会(House Energy and Commerce Committee)致信即将离任的FDA专员戈特利布(Scott Gottlieb),询问有关海外药品包装工厂的检查情况。最近至少有12种心血管药物被召回,包括氨氯吡定、厄贝沙坦和缬沙坦。
The FDA cautions that if you take any medications for hypertension, it is important not to discontinue use until you speak with your physician. Not taking blood pressure medication can be extremely dangerous, even if the risks associated with taking a medication tainted with a toxin also seem high. FDA警告说,如果你服用任何治疗高血压的药物,重要的是在与医生交谈之前不要停止使用。即使服用含有毒素的药物的风险似乎也很高,但不服用降压药是非常危险的。
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