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https://tw.news.yahoo.com/又驗出致癌藥-322萬顆高血壓藥-脈莎平-下架回收-061727643.html
又驗出致癌藥!322萬顆高血壓藥「脈莎平」下架回收

新頭殼
3.6k 人追蹤
新頭殼newtalk |閻芝霖
2018年12月29日 下午2:17
[新頭殼newtalk] 高血壓藥又驗出致癌物!食藥署今(29)日表示,壽元化學工業股份有限公司生產的降血壓藥「脈莎平膜衣錠50毫克」因使用了含有致癌物「N-亞硝基二乙胺」的原料藥,將市面上共11批、322萬顆藥物下架回收,食藥署也呼籲吃到問題降血壓藥的民眾勿擅自停藥,有疑慮應儘速回診,與醫師討論換藥。
衛生福利部食品藥物管理署在27日公布一項回收警訊指出,壽元化學工業股份有限公司旗下「脈莎平膜衣錠50毫克」使用的原料藥驗出含有致癌疑慮的「N-亞硝基二乙胺」(NDEA)不純物,即起將展開回收。
食藥署藥品組科長洪國登表示,今年7月起陸續傳出有中國大陸、印度藥廠製造的降血壓原料藥,被驗出含有致癌疑慮的「N-亞硝基二甲胺」(NDMA)以及NDEA,因此食藥署隨即針對市售降血壓原料藥展開清查,並要求業者自主檢驗。
洪國登指出,用到問題原料的脈莎平膜衣錠共有11批、322萬顆,即日起將全面下架回收,問題批號分別是511193、601083、601233、601243、606193、607023、607033、609173、610013、610023及702043,預計1個月內下架完畢。
洪國登解釋,NDEA、N-亞硝基二甲胺(NDMA)都是製程中出現不可預期的副產物,目前中國大陸、印度都有藥廠生產的原料藥含此成分,呼籲吃到問題降血壓藥的民眾勿擅自停藥,有疑慮應儘速回診,與醫師討論換藥。
Also detected a carcinogen! 3.22 million high-pressure medicine "Zha Shaping" was taken off the shelf
[new head shell]
New head shell
3.6k person tracking
New head shell newtalk |阎芝霖
December 29, 2018, 2:17 PM
[New head shell newtalk] Hypertensive drugs have detected carcinogens! The Food and Drug Administration said today (29) that the antihypertensive drug "50 mg of maisha flat film ingot" produced by Shouyuan Chemical Industry Co., Ltd. uses raw materials containing the carcinogen "N-nitrosodiethylamine". Drugs, the market a total of 11 batches, 3.22 million drugs off the shelf, the Food and Drug Administration also appealed to people who have problems with blood pressure lowering drugs do not stop the drug, have doubts should return to the doctor as soon as possible, and discuss the dressing with the doctor.
The Food and Drug Administration of the Ministry of Health and Welfare announced on the 27th that a recycling warning indicated that the raw materials used in the "50 mg of the pulsed flat film ingot" of Shouyuan Chemical Industry Co., Ltd. detected "N-Asia" containing cancer causing doubts. Nitro-diethylamine (NDEA) is an impurity that will be recycled.
Hong Guodeng, head of the drug group of the Food and Drug Administration, said that since July this year, blood pressure lowering drugs manufactured by Chinese mainland and Indian pharmaceutical companies have been reported, and N-nitrosodimethylamine (NDMA) containing cancer causing doubts has been detected. ) and NDEA, so the Food and Drug Administration immediately launched a check on the commercially available blood pressure lowering drug substance, and asked the industry to independently test.
Hong Guodeng pointed out that there are 11 batches and 3.22 million pieces of zisha flat film ingots that use the raw materials of the problem. From now on, they will be completely removed from the shelves. The problem batch numbers are 511193, 601083, 601233, 601243, 606193, 607023, 607033, 609173, respectively. 610013, 610023 and 702043 are expected to be completed within one month.
Hong Guodeng explained that NDEA and N-nitrosodimethylamine (NDMA) are unpredictable by-products in the process. At present, there are pharmaceutical ingredients produced in pharmaceutical factories in mainland China and India that contain this ingredient, calling for problems to lower blood pressure. The people of the medicine should not stop taking the medicine without authorization. If they have doubts, they should return to the doctor as soon as possible and discuss the dressing change with the doctor.
又驗出致癌藥!322萬顆高血壓藥「脈莎平」下架回收

新頭殼
3.6k 人追蹤
新頭殼newtalk |閻芝霖
2018年12月29日 下午2:17
[新頭殼newtalk] 高血壓藥又驗出致癌物!食藥署今(29)日表示,壽元化學工業股份有限公司生產的降血壓藥「脈莎平膜衣錠50毫克」因使用了含有致癌物「N-亞硝基二乙胺」的原料藥,將市面上共11批、322萬顆藥物下架回收,食藥署也呼籲吃到問題降血壓藥的民眾勿擅自停藥,有疑慮應儘速回診,與醫師討論換藥。
衛生福利部食品藥物管理署在27日公布一項回收警訊指出,壽元化學工業股份有限公司旗下「脈莎平膜衣錠50毫克」使用的原料藥驗出含有致癌疑慮的「N-亞硝基二乙胺」(NDEA)不純物,即起將展開回收。
食藥署藥品組科長洪國登表示,今年7月起陸續傳出有中國大陸、印度藥廠製造的降血壓原料藥,被驗出含有致癌疑慮的「N-亞硝基二甲胺」(NDMA)以及NDEA,因此食藥署隨即針對市售降血壓原料藥展開清查,並要求業者自主檢驗。
洪國登指出,用到問題原料的脈莎平膜衣錠共有11批、322萬顆,即日起將全面下架回收,問題批號分別是511193、601083、601233、601243、606193、607023、607033、609173、610013、610023及702043,預計1個月內下架完畢。
洪國登解釋,NDEA、N-亞硝基二甲胺(NDMA)都是製程中出現不可預期的副產物,目前中國大陸、印度都有藥廠生產的原料藥含此成分,呼籲吃到問題降血壓藥的民眾勿擅自停藥,有疑慮應儘速回診,與醫師討論換藥。
Also detected a carcinogen! 3.22 million high-pressure medicine "Zha Shaping" was taken off the shelf
[new head shell]
New head shell
3.6k person tracking
New head shell newtalk |阎芝霖
December 29, 2018, 2:17 PM
[New head shell newtalk] Hypertensive drugs have detected carcinogens! The Food and Drug Administration said today (29) that the antihypertensive drug "50 mg of maisha flat film ingot" produced by Shouyuan Chemical Industry Co., Ltd. uses raw materials containing the carcinogen "N-nitrosodiethylamine". Drugs, the market a total of 11 batches, 3.22 million drugs off the shelf, the Food and Drug Administration also appealed to people who have problems with blood pressure lowering drugs do not stop the drug, have doubts should return to the doctor as soon as possible, and discuss the dressing with the doctor.
The Food and Drug Administration of the Ministry of Health and Welfare announced on the 27th that a recycling warning indicated that the raw materials used in the "50 mg of the pulsed flat film ingot" of Shouyuan Chemical Industry Co., Ltd. detected "N-Asia" containing cancer causing doubts. Nitro-diethylamine (NDEA) is an impurity that will be recycled.
Hong Guodeng, head of the drug group of the Food and Drug Administration, said that since July this year, blood pressure lowering drugs manufactured by Chinese mainland and Indian pharmaceutical companies have been reported, and N-nitrosodimethylamine (NDMA) containing cancer causing doubts has been detected. ) and NDEA, so the Food and Drug Administration immediately launched a check on the commercially available blood pressure lowering drug substance, and asked the industry to independently test.
Hong Guodeng pointed out that there are 11 batches and 3.22 million pieces of zisha flat film ingots that use the raw materials of the problem. From now on, they will be completely removed from the shelves. The problem batch numbers are 511193, 601083, 601233, 601243, 606193, 607023, 607033, 609173, respectively. 610013, 610023 and 702043 are expected to be completed within one month.
Hong Guodeng explained that NDEA and N-nitrosodimethylamine (NDMA) are unpredictable by-products in the process. At present, there are pharmaceutical ingredients produced in pharmaceutical factories in mainland China and India that contain this ingredient, calling for problems to lower blood pressure. The people of the medicine should not stop taking the medicine without authorization. If they have doubts, they should return to the doctor as soon as possible and discuss the dressing change with the doctor.