活性葉酸有比較好嗎？
2019年10月22日 星期二
2019年2月27日 星期三
20190227 最新血壓藥下架公告！！ 看不懂直接看圖，就知道！
食藥署說明沙坦類（sartan）藥品中「N-亞硝基二甲胺（NDMA）」及「N-亞硝基二乙胺（NDEA）」之處理現況！
有關沙坦類（Sartan）藥品部分原料藥含有動物致癌性成分「N-亞硝基二甲胺（NDMA）」或「N-亞硝基二乙胺（NDEA）」事件，衛生福利部食品藥物管理署(以下簡稱食藥署) ，未輕忽為單一事件，以主動積極態度，採取一連串加強管制措施，除暫停輸入有問題之原料藥來源、主動抽驗各來源之原料藥或製劑外，並於最短時間內開發出sartan類原料藥及製劑中NDEA及NDMA之檢驗方法，公布供各界參考引用，要求製劑廠逐批檢驗sartan類藥品原料藥，並應於107年12月26日前完成檢驗。惟囿於該檢驗方法所需之高靈敏度檢驗儀器與特殊檢出器，一般藥廠不具有該設備，故食藥署已儘速輔導並認證4家民間實驗室協助藥廠進行NDMA、NDEA之檢驗，並要求廠商應於108年3月11日前完成檢驗，並回報食藥署其檢驗結果；倘有檢出NDEA或NDMA不符限量規定者，並應立即通知食藥署。
近日食藥署陸續接獲廠商通報其自主檢驗結果，今接獲瑩碩生技醫藥股份有限公司（以下簡稱瑩碩公司）及美商亞培股份有限公司台灣分公司（以下簡稱亞培公司）通知，經該等公司自主檢驗106年留樣之Valsartan原料藥，有3批原料藥檢出含有NDMA (來源:中國浙江天宇藥業股份有限公司；批號：10200-170925、10200-160911及10200-160417)，該等批號原料藥所涉及之藥品包括瑩碩公司3批「德壓悅膜衣錠160毫克」、6批「可德壓悅膠囊 80/12.5 毫克」藥品及亞培公司19批「易德壓悅膜衣錠5/80毫克」藥品(清單如附件)。食藥署已於今(27)日要求該等公司即刻起下架停止供應，並應於1個月內(108年3月27日前)完成回收。
食藥署另請衛生局督導下架回收事宜，健保署並已透過VPN通知醫療機構及藥局。食藥署提醒正在使用該等藥品的患者，該等藥品主要用於高血壓等需定期服藥控制之疾病，故不建議任意停藥，應儘速回診時，與醫師討論，處方其他適當藥品。
食藥署針對含sartan類藥品成分(Valsartan, Losartan, Irbesartan, Olmesartan, Candesartan) 之效期內輸入製劑、國產製劑所使用之原料藥已展開全面調查，經食藥署抽樣檢驗145件原料藥(來自20項原料)與53件輸入製劑，檢出含NDMA或NDEA檢體共44件，均為來自之前已發佈有檢出NDMA或NDEA的5項原料藥，分別為來源為「中國浙江華海製藥公司」、「中國珠海潤都製藥公司」、「中國浙江天宇藥業股份有限公司」、「印度Mylan Laboratories Limited 公司」等的Valsartan原料藥，以及「印度Aurobindo Pharma Limited公司」之Irbesartan原料藥等5項原料藥，食藥署皆已要求暫停輸入與供應。
有關沙坦類（Sartan）類藥品有部分原料藥檢出有動物致癌性成分NDMA及NDEA，該等成分雖具動物致癌性，然對人類資料尚未證明。依據國際藥政管理單位推論，該等不純物產生原因可能與製程相關，為一種未預期之不純物，因此各國藥典亦皆未訂定NDMA、NDEA之檢驗方法及限量標準。
食藥署針對沙坦類原料藥可能含有NDMA或NDEA事件，未輕忽為單一事件，以主動積極態度，全面進行原料藥及製劑之調查與檢驗，並於最短時間內開發出sartan類原料藥及製劑中NDEA及NDMA之檢驗方法，公布供各界參考引用，並要求製劑廠對於沙坦類（Sartan）成分之藥品原料藥須逐批檢驗，未檢出NDMA及NDEA始得供製造使用，並納入GMP稽查重點，以確保業者落實執行。後續，食藥署將持續與國際合作，以快速取得最新資訊，對於受影響藥品，將即時公布受影響藥品資訊，並透過多重管道提醒醫療人員及民眾注意，以保障民眾用藥安全。
2018年11月2日 星期五
下架平壓妥膜衣錠300毫克(衛部藥製字第058235號)因含NEDA
衛生福利部食品藥物管理署(以下簡稱食藥署) 於監視國際藥物安全訊息時，發現印度Aurboindo Pharma Limited公司所生產高血壓治療藥品原料藥Irbesartan含「N-亞硝基二乙胺」（NDEA）成分，該成分具動物致癌性，對人體資料尚未證實，惟為確保民眾用藥安全，食藥署立即清查所有該成分之製劑品許可證，發現健亞生物科技股份有限公司之「平壓妥膜衣錠300毫克(衛部藥製字第058235號)」使用該原料藥，該公司已於今(2)日主動啟動該藥品之回收作業(回收批號如附件)。
食藥署並於今(2)日要求業者即時通知醫療機構及藥局立即下架停止供應，並於1個月內(107年12月2日前)完成回收，請衛生局督導下架回收事宜。另提醒正在使用該藥品的患者，該藥品主要用於高血壓等需定期服藥控制之疾病，故不建議任意停藥，應儘速回診時，與醫師討論，處方其他適當藥品。
為確保藥物安全與醫療效能，食藥署已建置藥物安全監測機制，即時監視國內、外藥物安全訊息，除設有藥物不良反應通報系統及藥物不良品通報中心之外，並對於藥物之安全性與療效亦隨時進行再評估，如醫療人員或病患疑似因使用（服用）藥品導致不良反應之發生，請立即通報衛生福利部所建置之全國藥物不良反應通報中心，藥物不良反應通報專線02-2396-0100，網站：https://adr.fda.gov.tw。
如發現藥物不良品時，請立即通報衛生福利部所建置之全國藥物不良品通報中心，藥物不良品通報專線02-6625-1166分機6401，網站： https://qms.fda.gov.tw。
2018年8月4日 星期六
搞懂VALSARTAN內含N-亞硝基二甲胺事件
首先，先了解N-亞硝基二甲胺。
N-亞硝基二甲胺（英語：N-Nitrosodimethylamine, NDMA）又稱二甲基亞硝胺，是一種半揮發性有機化學品，氣味很弱，易溶於水及醇、醚等有機溶劑，極易光解。NDMA具有強肝臟毒性，屬IARC第2A類致癌物質。主要用於火箭燃料、抗氧劑等製造。
N-亞硝基二甲胺由二甲胺與亞硝酸鹽在酸性條件下反應而生成，微量存在於多種食物中，例如：醃製食品、魚、啤酒和菸草煙霧中等，但是它不會在生物體中累積。
N-亞硝基二甲胺還是以氯或二氧化氯消毒自來水時的可能副產物，而用臭氧作消毒劑則不會生成。
NDMA不易降解或揮發，且不能被活性炭吸附，因此不容易從飲用水中去除。
美國環保署已規定飲用水中的N-亞硝基二甲胺最大容許濃度為每升中7奈克，尚未設置飲用水監管的最大污染物水平（MCL）。
N-亞硝基二甲胺急性中毒可引起肝臟損傷、血液血小板計數下降、轉氨酶濃度升高，還包括頭痛，發燒，嘔吐，腹痛，分散性皮下出血，嗜睡，噁心，腹瀉等症狀。
較小劑量的長期暴露也可能增加肝癌風險。N-亞硝基二甲胺小鼠口服半數致死量（LD50）為37.0mg/kg。
比起降血壓藥中的N-亞硝基二甲胺(NDMA)，民眾在日常更容易接觸的是亞硝酸鹽，存在蔬菜、菸、酒、檳榔與醃漬的魚或肉，例如：火腿、培根、熱狗等。
它若在體內和胺作用就會形成致癌物亞硝胺(煙、酒、檳榔中，是直接以亞硝胺形態存在)，會引發肝炎、肝癌、口腔癌、胃癌、食道癌、鼻咽癌、胰臟癌、氣管炎等。當亞硝酸鹽會與腸道或蔬菜、醃漬物等食物中的次級胺結合，會形成亞硝胺，就會對人體產生影響，長期下來就會導致罹癌的風險大增。
因此，平日少吃這些食物，或在食用這些東西先水煮，可降低體內亞硝胺含量。此外，多吃五穀雜糧等高纖維類食物，可促進腸胃蠕動，抑制腸道壞菌生長，減少亞硝酸的合成；而多補充維生素C和益生菌，也可幫助代謝腸道中的亞硝酸鹽，保持腸道平衡。
台灣衛生福利部食品藥物管理署於
2018/7/8
食藥署調查使用中國大陸浙江華海製藥公司valsartan原料藥之異常事件說明
2018/7/9
食藥署調查使用中國大陸浙江華海製藥公司valsartan原料藥之異常事件接續說明
2018/8/2
食藥署全面調查valsartan原料藥異常事件說明
2018/8/3
輸入valsartan原料藥已完成清查，未有新增其他市售藥品受影響
Update on review of recalled valsartan medicines
Update on review of recalled valsartan medicines
Preliminary assessment of possible risk to patients
EMA is conducting a review of the possible health effects in patients who may have taken valsartan medicines containing N-nitrosodimethylamine (NDMA) – an impurity found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on animal tests. It is present in some foods and water supplies but is not expected to cause harm when ingested in very low levels.
Following a preliminary evaluation, EMA estimates that there could be one extra case of cancer for every 5,000 patients taking the affected medicines at the highest valsartan dose (320 mg) every day for 7 years. This is based on average levels of this impurity detected in the active substance from Zhejiang Huahai Pharmaceuticals (60 parts per million).
The possible cancer risk has been extrapolated from animal studies and should be considered in the context of the lifetime risk of cancer in the EU (1 in 3) and NDMA exposure from other sources.
This preliminary estimate is based on the assumption that the NDMA present in the active substance is carried over in the final product in the same amount.
Companies that had used the active substance from Zhejiang Huahai in their valsartan medicines are required to test samples they hold to determine the actual NDMA levels in the final products. Additional checks are being carried out by EU official control laboratories. Once data from all these tests are available, EMA will be able to provide more information on the risk that the impurity may have posed for patients in the EU.
It is important to note that there is no immediate risk to patients. Patients taking the affected medicines who have not yet switched to an alternative should not stop taking their medicines without consulting their doctor or pharmacist.
Valsartan medicines are used for patients with serious or potentially serious conditions of the circulatory system (high blood pressure, a recent heart attack and heart failure). It is therefore not advisable to go without treatment if a treatment has been prescribed.
All valsartan medicines containing the active substance from Zhejiang Huahai Pharmaceuticals have been recalled from pharmacies in the EU but several other valsartan medicines not affected by the impurity are available. Patients who want more information about their treatments should contact their doctor or pharmacist. Further information is provided by national medicines authorities.
NDMA was an unexpected impurity believed to have formed as a side product after Zhejiang Huahai introduced changes to its manufacturing process in 2012. No other active substances produced by the company are affected.
EMA is working closely with international partners and will provide further information on its website as the review progresses.
More about the medicine
Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own or in combination with other active substances.
The review covers all medicines that contain valsartan supplied by Zhejiang Huahai Pharmaceuticals. As a precaution, the review will also consider whether other valsartan medicines may be affected.
More about the procedure
The review of valsartan medicines in relation to NDMA found in the active substance from Zhejiang Huahai Pharmaceuticals was triggered by the European Commission on 5 July 2018 Article 31 of Directive 2001/83/EC.
The review is being carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
EMA Updates on Recalled Valsartan Medicines
N-亞硝基二甲胺（英語：N-Nitrosodimethylamine, NDMA）又稱二甲基亞硝胺，是一種半揮發性有機化學品，氣味很弱，易溶於水及醇、醚等有機溶劑，極易光解。NDMA具有強肝臟毒性，屬IARC第2A類致癌物質。主要用於火箭燃料、抗氧劑等製造。
N-亞硝基二甲胺由二甲胺與亞硝酸鹽在酸性條件下反應而生成，微量存在於多種食物中，例如：醃製食品、魚、啤酒和菸草煙霧中等，但是它不會在生物體中累積。
N-亞硝基二甲胺還是以氯或二氧化氯消毒自來水時的可能副產物，而用臭氧作消毒劑則不會生成。
NDMA不易降解或揮發，且不能被活性炭吸附，因此不容易從飲用水中去除。
美國環保署已規定飲用水中的N-亞硝基二甲胺最大容許濃度為每升中7奈克，尚未設置飲用水監管的最大污染物水平（MCL）。
N-亞硝基二甲胺急性中毒可引起肝臟損傷、血液血小板計數下降、轉氨酶濃度升高，還包括頭痛，發燒，嘔吐，腹痛，分散性皮下出血，嗜睡，噁心，腹瀉等症狀。
較小劑量的長期暴露也可能增加肝癌風險。N-亞硝基二甲胺小鼠口服半數致死量（LD50）為37.0mg/kg。
比起降血壓藥中的N-亞硝基二甲胺(NDMA)，民眾在日常更容易接觸的是亞硝酸鹽，存在蔬菜、菸、酒、檳榔與醃漬的魚或肉，例如：火腿、培根、熱狗等。
它若在體內和胺作用就會形成致癌物亞硝胺(煙、酒、檳榔中，是直接以亞硝胺形態存在)，會引發肝炎、肝癌、口腔癌、胃癌、食道癌、鼻咽癌、胰臟癌、氣管炎等。當亞硝酸鹽會與腸道或蔬菜、醃漬物等食物中的次級胺結合，會形成亞硝胺，就會對人體產生影響，長期下來就會導致罹癌的風險大增。
因此，平日少吃這些食物，或在食用這些東西先水煮，可降低體內亞硝胺含量。此外，多吃五穀雜糧等高纖維類食物，可促進腸胃蠕動，抑制腸道壞菌生長，減少亞硝酸的合成；而多補充維生素C和益生菌，也可幫助代謝腸道中的亞硝酸鹽，保持腸道平衡。
台灣衛生福利部食品藥物管理署於
2018/7/8
食藥署調查使用中國大陸浙江華海製藥公司valsartan原料藥之異常事件說明
2018/7/9
食藥署調查使用中國大陸浙江華海製藥公司valsartan原料藥之異常事件接續說明
2018/8/2
食藥署全面調查valsartan原料藥異常事件說明
2018/8/3
輸入valsartan原料藥已完成清查，未有新增其他市售藥品受影響
Update on review of recalled valsartan medicines
Update on review of recalled valsartan medicines
Preliminary assessment of possible risk to patients
EMA is conducting a review of the possible health effects in patients who may have taken valsartan medicines containing N-nitrosodimethylamine (NDMA) – an impurity found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on animal tests. It is present in some foods and water supplies but is not expected to cause harm when ingested in very low levels.
Following a preliminary evaluation, EMA estimates that there could be one extra case of cancer for every 5,000 patients taking the affected medicines at the highest valsartan dose (320 mg) every day for 7 years. This is based on average levels of this impurity detected in the active substance from Zhejiang Huahai Pharmaceuticals (60 parts per million).
The possible cancer risk has been extrapolated from animal studies and should be considered in the context of the lifetime risk of cancer in the EU (1 in 3) and NDMA exposure from other sources.
This preliminary estimate is based on the assumption that the NDMA present in the active substance is carried over in the final product in the same amount.
Companies that had used the active substance from Zhejiang Huahai in their valsartan medicines are required to test samples they hold to determine the actual NDMA levels in the final products. Additional checks are being carried out by EU official control laboratories. Once data from all these tests are available, EMA will be able to provide more information on the risk that the impurity may have posed for patients in the EU.
It is important to note that there is no immediate risk to patients. Patients taking the affected medicines who have not yet switched to an alternative should not stop taking their medicines without consulting their doctor or pharmacist.
Valsartan medicines are used for patients with serious or potentially serious conditions of the circulatory system (high blood pressure, a recent heart attack and heart failure). It is therefore not advisable to go without treatment if a treatment has been prescribed.
All valsartan medicines containing the active substance from Zhejiang Huahai Pharmaceuticals have been recalled from pharmacies in the EU but several other valsartan medicines not affected by the impurity are available. Patients who want more information about their treatments should contact their doctor or pharmacist. Further information is provided by national medicines authorities.
NDMA was an unexpected impurity believed to have formed as a side product after Zhejiang Huahai introduced changes to its manufacturing process in 2012. No other active substances produced by the company are affected.
EMA is working closely with international partners and will provide further information on its website as the review progresses.
More about the medicine
Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own or in combination with other active substances.
The review covers all medicines that contain valsartan supplied by Zhejiang Huahai Pharmaceuticals. As a precaution, the review will also consider whether other valsartan medicines may be affected.
More about the procedure
The review of valsartan medicines in relation to NDMA found in the active substance from Zhejiang Huahai Pharmaceuticals was triggered by the European Commission on 5 July 2018 Article 31 of Directive 2001/83/EC.
The review is being carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
EMA Updates on Recalled Valsartan Medicines
Posted 02 August 2018 | By Ana Mulero
EMA Updates on Recalled Valsartan Medicines
An initial health risk assessment conducted by the European Medicines Agency (EMA) projects a hypothetical increase in cancer cases among patients who took certain medicines with a Chinese company’s active substance that was previously found to contain an impurity.
“There could be one extra case of cancer for every 5,000 patients” who took valsartan supplied by Zhejiang Huahai Pharmaceuticals at its highest dosage each day for seven years, EMA reported on Thursday. The estimates are based on the average levels of the chemical impurity N-nitrosodimethylamine (NDMA) that the company detected in the valsartan medicines.
NDMA had been classified as a probable human carcinogen prior to the investigation that resulted in an international recall of the affected blood pressure and heart medicines.
“The possible cancer risk has been extrapolated from animal studies and should be considered in the context of the lifetime risk of cancer in the EU (1 in 3) and NDMA exposure from other sources,” EMA clarified. “This preliminary estimate is based on the assumption that the NDMA present in the active substance is carried over in the final product in the same amount.”
The recall was initiated throughout Europe in early July, followed by the US Food and Drug Administration (FDA). FDA concluded in its analysis, released last week, that “some levels of the impurity may have been in the valsartan-containing products for as long as four years.”
EMA’s ongoing investigation also requires all drug manufacturers that have used Zhejiang Huahai Pharmaceuticals’ valsartan to test samples to determine NDMA levels in finished medicines. The agency intends to provide another update once these data area available.
2018年7月30日 星期一
2018年7月7日 星期六
(8/4)更新(新增生達製藥四種藥品) (新增19個批號)您或您家人吃的血壓藥有問題嗎？台灣六款降血壓藥疑含動物致癌成分 需立即下架
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台灣六款降血壓藥疑含動物致癌成分 需立即下架
如果您不知道您服用的藥品是否有問題，歡迎到新德大藥局來或是用官方LINE諮詢
https://www.新德大藥局.com/line299832796322280.html
https://www.新德大藥局.com/line299832796322280.html
「永信」樂速降膜衣錠80毫克 該藥健保碼 AC57381100
「生達」舒心樂膜衣錠 160 毫克 該藥健保碼 AB55557100
「生達」舒心樂膜衣錠 80 毫克 該藥健保碼 AB55585100
「瑞安」凡內膜衣錠160毫克 該藥健保碼 AC58537100
「瑪科隆」科適壓膜衣錠80/12.5毫克 該藥健保碼 AC57371100
領有慢箋的朋友可以核對您處方箋上的健保碼。
冰島阿特維斯（actavis）藥廠委託中國原料藥廠製作的抗高血壓藥物，傳疑似含有致癌物，諾華藥廠表示，此次事件與諾華藥廠生產的「得安穩」無關。
諾華藥廠發出聲明表示，部分媒體誤植內容報導，指之前報導中的產品（得安穩）為中國浙江華海製藥出產的高血壓學名藥。
聲明說，「得安穩」是瑞士諾華製造生產原裝進口的高血壓藥物，經過美國歐盟台灣衛生主管機關核準，安全性無虞。
衛福部食藥署藥品組副組長祈若鳳強調，該問題藥物沒有進到台灣，請民眾安心
中國大陸浙江華海製藥所生產高血壓治療藥品原料藥valsartan發現含「N-亞硝基二甲胺」（NDMA）成分，該成分具動物致癌性，衛生福利部食品藥物管理署今天清查後發現，在71項已核發該成分的製劑品許可證中，6項藥品使用該原料藥，分別為「生達」舒心樂膜衣錠 160 毫克、「生達」舒心樂膜衣錠 80 毫克、「瑪科隆」科適壓膜衣錠80/12.5毫克、「永信」樂速降膜衣錠160毫克、「永信」樂速降膜衣錠80毫克及凡內膜衣錠160毫克。
為確保民眾用藥安全，食藥署要求業者啟動回收作業，通知醫療機構及藥局立即下架停止供應，並於1個月內(107年8月7日前)完成回收，並請衛生局督導下架回收事宜，業者後續則應使用其他來源的原料藥。
至於正在服用上述6款藥品的患者，食藥署指出，該藥品主要用於高血壓等需定期服藥控制之疾病，不建議任意停藥，應盡速回診時，與醫師討論，處方其他適當藥品。
為確保藥物安全與醫療效能，食藥署指出，早已建置藥物安全監測機制，即時監視國內、外藥物安全訊息，設有藥物不良反應通報系統及藥物不良品通報中心，並隨時評估藥物之安全性與療效。
2018年6月22日 星期五
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