日前中國華海製藥公司生產的纈沙坦原料藥，遭歐盟測出動物性致癌物「N-亞硝基二甲胺」（NDMA），台灣下架超過2千萬顆。美國FDA於13日發布最新報告指出，在1家已經召回廠商的3款藥物中（台灣無進口），發現另一種動物和可疑的人類致癌物質「N-甲基二乙醇胺」（NDEA）。歐洲藥品管理局和FDA公布的研究也指出，NDMA罹癌風險相當低。
FDA發布最新聲明指出，有3批Torrent製藥公司召回的纈沙坦藥物產品中存在額外的雜質NDEA，其與NDMA都是動物和可疑的人類致癌物質。因此，FDA立即開始重新測試所有纈沙坦藥品，包括下架的和目前仍在銷售的產品。FDA局長戈特利布強調，他們還在釐清製程產生致癌物質的原因，以及評估NDEA的危害，確保其他藥物不會有相同情況。
《CNN》報導，FDA同時也發布NDMA的最新風險評估指出，如果每天有8000人服用含有NDMA的纈沙坦藥物（最高劑量320mg），持續4年，可能只會多出1例癌症。歐洲藥品管理局的最新研究也顯示，如患者從2012年開始服用最高劑量的致癌藥物至2018年，罹癌機率只有1/5000。據悉，NDEA的風險評估正在進行中，FDA還將發佈監測NDEA的初步方法，供全球藥商和監管機構使用。
小編評：之前中國藥物原料含NMDA的相關報導如下，感覺中國藥品原料真的在世界上風評真的不太好，一直驗出有問題…
The U.S. Food and Drug Administration is updating the public on the agency’s ongoing investigation surrounding the recent voluntary recall of several drug products containing the active pharmaceutical ingredient (API) valsartan, used to treat high blood pressure and heart failure.
The FDA’s latest testing of products shows an additional unexpected impurity in three lots of Torrent Pharmaceuticals’ recalled valsartan drug products. This second impurity, N-Nitrosodiethylamine (NDEA) is a known animal and suspected human carcinogen. These Torrent products were included in the company’s recall on August 23, 2018.
The FDA and the European Medicines Agency have learned that Zhejiang Huahai Pharmaceuticals (ZHP) found NDEA in several batches of its valsartan API. The FDA immediately began retesting all valsartan API and products, including both recalled products and those currently marketed in the United States, for NDEA. Based on FDA testing to date, the agency discovered NDEA in some of ZHP’s valsartan API. This impurity was also found in Torrent’s valsartan 160mg (lot BV47D001) and 320mg (lots BV48D001 and BV48D002) tablets, which were made using API from ZHP and were part of the earlier recall. The FDA’s testing shows that not all products made using ZHP valsartan API contain the NDEA impurity.
小編評：美國FDA對於NDEA的警示說明…
連結：Update on review of valsartan medicines Risk from NDMA remains low, a related substance NDEA also being investigated （13 September 2018 EMA/585263/2018）
The European Medicines Agency (EMA) has updated its calculation of the risk from valsartan medicines containing N-nitrosodimethylamine (NDMA), taking into account results from latest tests on the active substance from Zhejiang Huahai.
In line with EMA’s previous assessment, the life-time risk of cancer is considered low and is estimated to be in the order of 1 in 5,000 for an adult patient who had taken an affected valsartan medicine at the highest dose (320 mg) every day from July 2012 to July 2018.
EMA’s risk assessment is based on the average levels of NDMA in the active substance produced by Zhejiang Huahai since 2012 (when the company changed its manufacturing process) and on the
assumption that all the NDMA is transferred to the final product.
Patients who have taken treatments with lower doses or for shorter lengths of time will be at a lower risk. The risk will also be lower for patients who have taken valsartan produced by Zhejiang Tianyu, which had smaller amounts of NDMA than valsartan produced by Zhejiang Huahai.
小編評：新聞稿中提到的歐盟評估報告就是這篇，有興趣的人可以看看。