{"id":38626,"date":"2018-08-18T01:00:00","date_gmt":"2018-09-17T06:22:57","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/fda%e6%8f%90%e9%86%92%e5%88%b6%e8%8d%af%e5%95%86%e5%8f%ac%e5%9b%9e%e4%b8%ad%e5%9b%bd%e6%9f%90%e8%8d%af%e5%8e%82%e7%9a%84%e7%94%b2%e7%8a%b6%e8%85%ba%e7%b4%a0%e5%8e%9f%e6%96%99%e8%8d%afapi\/"},"modified":"2018-09-17T14:22:58","modified_gmt":"2018-09-17T06:22:58","slug":"fda%e6%8f%90%e9%86%92%e5%88%b6%e8%8d%af%e5%95%86%e5%8f%ac%e5%9b%9e%e4%b8%ad%e5%9b%bd%e6%9f%90%e8%8d%af%e5%8e%82%e7%9a%84%e7%94%b2%e7%8a%b6%e8%85%ba%e7%b4%a0%e5%8e%9f%e6%96%99%e8%8d%afapi","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/38626\/","title":{"rendered":"FDA\u63d0\u9192\u5236\u836f\u5546\u53ec\u56de\u4e2d\u56fd\u67d0\u836f\u5382\u7684\u7532\u72b6\u817a\u7d20\u539f\u6599\u836fAPI"},"content":{"rendered":"
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FDA alerts drug makers of a recall of porcine thyroid API fromSichuan Friendly Pharmaceutical Co., Limited, China<\/span><\/p>\n


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FDA testing confirms inconsistent potency in the active ingredient<\/em><\/strong><\/span><\/p>\n


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FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China,<\/span> is recalling certain lots of porcine thyroid API due to inconsistent quality of the API.<\/span> FDA recommends that manufacturers and compounders not use Sichuan Friendly\u2019s porcine thyroid API received since August 2015. <\/span>This thyroid API comes from porcine (pig) thyroid glands and is used to make a non-FDA approved  drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism (underactive thyroid).<\/span><\/p>\n


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FDA laboratory testing confirmed the Sichuan Friendly API has inconsistent levels of the active ingredients \u2013 levothyroxine and liothyronine \u2013 and should not be used to manufacture or compound drugs for patient use. <\/span>Risks associated with over or under treatment of hypothyroidism could result in permanent or life-threatening adverse health consequences.<\/span><\/p>\n


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FDA placed Sichuan Friendly on import alert 66-40 on March 22, 2018, based on current good manufacturing practice (CGMP) deviations observed during an FDA inspection.<\/span><\/p>\n


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However, FDA confirmed Sichuan Friendly\u2019s thyroid API remains in the U.S. supply chain. This API and the drug products made from it, present a safety risk to patients. Sichuan Friendly API may be repackaged and\/or relabeled before it is further distributed, and not all of the repackaged\/relabeled API identifies Sichuan Friendly as the original API manufacturer. Therefore, manufacturers and compounders who make levothyroxine and liothyronine drug products should contact their API supplier to verify the actual manufacturer of the thyroid API they received before using it. Sichuan Friendly\u2019s products may be labeled as \u201cThyroid Powder\u201d or \u201cThyroid Powder USP.\u201d <\/span><\/p>\n


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Additionally, manufacturers and compounders who have received API made by Sichuan Friendly should quarantine the API and associated drug products.<\/span> If manufacturers and compounders have API or drug products made from Sichuan Friendly API, FDA requests these companies contact FDA\u2019s regional offices.<\/span><\/p>\n


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FDA recommends patients talk to their health care professional before they stop taking their combination levothyroxine and liothyronine thyroid medicine. FDA also recommends that patients discuss FDA-approved hypothyroidism treatment options with their doctors, as combination levothyroxine and liothyronine products are not FDA-approved.<\/span><\/p>\n


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FDA advises patients not to use porcine thyroid medicine labeled as Westminster<\/strong><\/span><\/p>\n


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Additionally, on August 9, 2018, Westminster Pharmaceuticals LLC voluntarily recalled all unexpired lots of levothyroxine and liothyronine (thyroid tablets) 15mg, 30mg, 60mg, 90mg, and 120mg. These products were made using API from Sichuan Friendly. FDA laboratory testing confirmed inconsistent levels of levothyroxine and liothyronine. Therefore, FDA recommends patients not use porcine thyroid drug products made by Westminster.<\/span><\/p>\n


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FDA inspection and adverse event reporting<\/strong><\/span><\/p>\n


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FDA inspected the Sichuan Friendly\u2019s facility in 2017 and discovered serious quality deficiencies, including:<\/span><\/p>\n