{"id":11467,"date":"2018-07-15T01:00:00","date_gmt":"2018-07-30T04:05:19","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/30\/%e5%8d%8e%e6%b5%b7%e8%8d%af%e4%b8%9a%ef%bc%9afda%e5%8f%91%e5%b8%83%e5%8f%ac%e5%9b%9e%e5%85%ac%e5%91%8a\/"},"modified":"2018-07-30T12:05:19","modified_gmt":"2018-07-30T04:05:19","slug":"%e5%8d%8e%e6%b5%b7%e8%8d%af%e4%b8%9a%ef%bc%9afda%e5%8f%91%e5%b8%83%e5%8f%ac%e5%9b%9e%e5%85%ac%e5%91%8a","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/11467\/","title":{"rendered":"\u534e\u6d77\u836f\u4e1a\uff1aFDA\u53d1\u5e03\u53ec\u56de\u516c\u544a"},"content":{"rendered":"
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The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.
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The FDA\u2019s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.
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\u201cThe FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they\u2019re manufactured,\u201d said FDA Commissioner Scott Gottlieb, M.D. \u201cWhen we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we\u2019re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients\u2019 therapeutic needs are met in the United States with an adequate supply of unaffected medications.\u201d<\/span><\/p>\n

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Information for Patients and Health Care Professionals<\/strong><\/span><\/p>\n