問題疫苗發酵之際還有一個大事件：華海葯業全球召回有毒心高血壓葯快查親戚朋友有沒有吃哈三聯的「纈沙坦分散片」

新聞 07-23

整個周末，小編和所有的家長一樣，被問題疫苗事件攪的身心無助，晚上吃飯碰到一波人，想想只有2個辦法，一個是今後所有疫苗和旅遊結合，估計會有這樣的組合，另一個辦法就是移民，當然的了大部人都和小編一樣「貧賤不能移」。

而其實，在問題疫苗發酵之際，有一個醫藥大事件就是華海葯業的有毒高血壓藥品！如果說現在發現的問題疫苗主要是沒功能，功能低的話，如果吃了這種有毒的高血壓藥品，就是真正有CA的可能，晚上查了一下老媽的葯，還好不是哈三聯的，但你能保證其他的沒毒？小編奇怪的是，歐洲和美國FDA都已經動作了，中國監管當局似乎沒啥聲音！

全球警報：華海葯業纈沙坦原料葯有毒！

身邊得高血壓的人越來越多，大概是人民生活水平提高的結果吧。

纈沙坦是主流降血壓藥物，該製劑屬於上市多年的經典藥物，目前並沒有發現特別異常的不良反應。

7月初，冰島牛B的大藥廠 actavis的降血壓藥品在歐洲藥品管理局EMA的例行檢測中發現了一項極為危險的藥物成分——N-亞硝基二甲胺！而這個東西被定義成致癌品，有毒，小編搜索這個東西，發現其實就是13年復旦投毒案中的危險品！

而actavis感覺非常委屈，因為這是一個成熟的產品，以前從來沒發生過問題，而這次的產品是委託我們浙江的華海製藥代工的！！於是，就發生了大家知道的事情，召回！

1、CNN：2300批次召回，從德國到馬爾他

召回涉及約2,300批次，分別送往德國，挪威，芬蘭，瑞典，匈牙利，荷蘭，奧地利，愛爾蘭，保加利亞，義大利，西班牙，葡萄牙，比利時，法國，波蘭，克羅埃西亞，立陶宛，希臘，加拿大，波士尼亞赫塞哥維納，巴林和馬爾他。

2、搞笑的是，國信證券的報告說，這更是機遇，因為美國的標準可能沒這麼高

3、美國FDA打臉召回在美國銷售的藥品

FDA宣布在檢測到雜質後，自願召回含有纈沙坦的幾種藥物

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.

The FDA』s 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.

「The 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』re manufactured,」 said FDA Commissioner Scott Gottlieb, M.D. 「When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we』re 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』 therapeutic needs are met in the United States with an adequate supply of unaffected medications.」

Information for Patients and Health Care Professionals

Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.

To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA』s website.

Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.

The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, Linhai, China. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. Zhejiang Huahai has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.

Recalled Products

「We have carefully assessed the valsartan-containing medications sold in the United States, and we』ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we』ve asked these companies to take immediate action to protect patients,」 said Janet Woodcock, M.D., director of the FDA』s Center for Drug Evaluation and Research.

The FDA will continue to investigate this issue and provide additional information when it becomes available. The agency encourages patients and health care professionals to report any adverse reaction to the FDA』s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation』s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

美國食品和藥物管理局正在提醒醫療保健專業人員和患者自願召回幾種含有活性成分纈沙坦的藥品，用於治療高血壓和心力衰竭。這次召回是由於召回產品中發現的雜質N-亞硝基二甲胺（NDMA）。但是，並非所有含有纈沙坦的產品都被召回。根據實驗室測試的結果，NDMA被歸類為可能的人類致癌物（一種可能導致癌症的物質）。 NDMA的存在是出乎意料的，並且被認為與活性物質的製造方式的變化有關。

FDA的審查正在進行中，其中包括調查召回產品中NDMA的水平，評估對服用這些產品的患者可能產生的影響，以及可採取哪些措施來減少或消除公司生產的未來批次中的雜質。

「FDA致力於維護我們的安全性和有效性的黃金標準。這包括我們為確保藥品質量及其製造的安全方式所做的努力，「FDA專員Scott Gottlieb醫師表示，」當我們確定藥品質量的缺失和製造方面的問題時，有可能造成對患者構成風險，我們承諾採取迅速行動提醒公眾，並幫助促進從市場上移除產品。當我們今天尋求去除某些藥物產品時，我們的藥物短缺團隊也在努力確保在美國滿足患者的治療需求，同時提供足夠的未受影響的藥物。「

患者和醫療保健專業人員的信息

由於纈沙坦用於治療嚴重疾病的藥物，服用含有纈沙坦的藥物的患者應該繼續服藥，直到他們有替代產品。

為確定特定產品是否已被召回，患者應查看其處方瓶標籤上的藥品名稱和公司名稱。如果信息不在瓶子上，患者應該聯繫分發藥物的藥房。

如果患者正在服用下列召回的藥物之一，則應遵循特定公司提供的召回說明。該信息將發布在FDA的網站上。

患者還應該聯繫他們的醫療保健專業人員（分發藥物的藥劑師或開藥的醫生），如果他們的藥物包括在本次召回中討論他們的治療，可能包括另一個不受此次召回影響的纈沙坦產品或替代治療選項。

下面列出的公司正在召回所有含有由中國臨海浙江華海葯業提供給他們的纈沙坦成分的非過期產品。並非所有在美國銷售的含纈沙坦的藥物都含有由該特定公司提供的纈沙坦活性藥物成分（API）。浙江華海已經停止銷售其纈沙坦API，FDA正在與受影響的公司合作，以減少或消除未來產品中的纈沙坦API雜質。