y****z
发帖数: 27 | 1 http://www.g.com.cn/health/49643835/
常见心血管药被爆“致癌”，22国紧急召回！
2018-07-10 由 影领影像医生集团 發表于健康
7月5日， 欧洲药品管理局（European Medicines Agency, EMA）发布公告[1]，宣布调
查我国浙江华海制药有限公司生产的缬沙坦（Valsartan）原料药。
调查原由是因为，在该原料药中发现一种可能的致癌杂质：N-亚硝基二甲胺（N-
Nitrosodimethylamine，NDMA）。目前，欧盟22国政府正在召回含有该公司生产缬沙坦
原料的药品。
Valsartan和NDMA是干嘛的？
Valsartan
该药主要用于治疗轻、中度原发性高血压，心力衰竭和心肌梗死。是临床常用药。也可
用于糖尿病预防和糖尿病肾病治疗（具体用法用量及适应证，参见本文附录）。
NDMA
NDMA是一种半挥发性有机化学品，气味与味道很弱，易溶于水、醇、醚等，是一种有毒
物品。主要用于火箭燃料、抗氧剂等制造。
NDMA由二甲胺与亚硝酸盐在酸性条件下反应而生成，微量存在于多种食品和消费品中，
例如可食用腌制肉、鱼、啤酒和烟草烟雾中等，但是它不会在生物体中富集。
NDMA还是用于自来水消毒的氯或二氧化氯的副产物（如下图），而用臭氧作消毒剂则不
会生成NDMA。它不容易降解、吸附或挥发，不能被活性炭吸附，因此不容易从饮用水中
去除。
NDMA经消化道、呼吸道吸收迅速，经皮肤吸收缓慢。动物实验表明，它主要引起肝脏、
肾脏和呼吸道肿瘤[2]。在2017年10月27日世界卫生组织国际癌症研究机构公布的致癌
物清单中，属于2A类致癌物。
（如果还不清楚，请读者自行百度2013年的“复旦投毒案”，在本频道不展开介绍。）
国内市场有这种药流通吗？
据证券网昨日发布的消息称[3]：“目前华海药业的缬沙坦原料药主要销往北美、欧洲
、印度、俄罗斯和南美等市场。该公司已停止了缬沙坦原料药的商业生产，对库存进行
了单独保存，暂停所有供应。此外，目前该公司缬沙坦制剂在国内尚未上市销售；同时
，该公司已对其他沙坦类产品进行了评估，因生产工艺不同，确认其他沙坦类产品中不
存在该NDMA 杂质。”
浙江华海药业发布公告称其已收到国家食品药品监督管理总局签发的缬沙坦片药品注册
批件。 |
y****z
发帖数: 27 | |
w**********g
发帖数: 5486 | 3 ssos？昨天抽你嘴巴，明目张胆造谣，现在换马甲 |
y****z
发帖数: 27 | 4 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002984.jsp&mid=WC0b01ac058004d5c1
EMA reviewing medicines containing valsartan from Zhejiang Huahai following
detection of an impurity
05/07/2018
EMA reviewing medicines containing valsartan from Zhejiang Huahai following
detection of an impurity
Some valsartan medicines being recalled across the EU
The European Medicines Agency (EMA) is reviewing medicines containing the
active substance valsartan that is supplied by Zhejiang Huahai
Pharmaceuticals, a company in Linhai, China.
The review was triggered after the company detected an impurity, N-
nitrosodimethylamine (NDMA), in the valsartan active substance which the
company supplies to manufacturers producing some of the valsartan medicines
available in the EU.
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.
While the review is underway, national authorities across the EU are
recalling medicines containing valsartan supplied by Zhejiang Huahai.
Valsartan medicines are used to treat patients with high blood pressure in
order to reduce complications such as heart attack and stroke. It is also
used in patients who have had heart failure or a recent heart attack.
EMA’s review will investigate the levels of NDMA in these valsartan
medicines, its possible impact 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. As a precaution, the review will also
consider whether other valsartan medicines may be affected.
The review will be carried out by EMA’s Committee for Medicinal Products
for Human Use (CHMP).
Information for patients
An unexpected impurity has been found in the active ingredient used to make
some valsartan medicines.
Only some valsartan medicines in the EU are affected and these are being
recalled.
You should not stop taking your valsartan medicine unless you have been told
to do so by your doctor or pharmacist.
You may be given a different valsartan medicine (or an alternative treatment
) when you go for your next prescription.
If you have any questions about your treatment, speak to your pharmacist who
can tell you if your medicine is being recalled.
If you are in a clinical trial with valsartan and have any questions, speak
to the doctor treating you in the trial.
EMA will assess whether the impurity may pose any risk for patients. Further
information will be provided once available.Information for healthcare
professionals
N-nitrosodimethylamine (NDMA) has been detected in the valsartan active
substance manufactured by Zhejiang Huahai Pharmaceuticals.
As a result, valsartan medicines containing the active substance from
Zhejiang Huahai are being recalled in the EU.
National authorities are contacting pharmacists with information on the
medicines to be recalled.
EMA is now evaluating potential impact on patients of the exposure to NDMA
in valsartan medicines. Further information will be provided once available.
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 medicines containing valsartan supplied by Zhejiang Huahai
Pharmaceuticals was triggered on 5 July 2018 by the request of the European
Commission, under Article 31 of Directive 2001/83/EC.
The review will be 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. |
y******e
发帖数: 143 | |
s**s
发帖数: 3374 | 6 傻逼
脸肿了吧？
【在 w**********g 的大作中提到】
: ssos？昨天抽你嘴巴，明目张胆造谣，现在换马甲
|
m********i
发帖数: 5 | 7 在地狱里下油锅制作出炸油条
光罚不行还要显形积极性
【在 y******e 的大作中提到】
: 妈的，应该下地狱
|
j****f
发帖数: 3552 | 8 浙江逼ok, lol
....
: ssos？昨天抽你嘴巴，明目张胆造谣，现在换马甲
【在 w**********g 的大作中提到】
: ssos？昨天抽你嘴巴，明目张胆造谣，现在换马甲
|
w**********g
发帖数: 5486 | 9 你明目张胆的造谣，长生生物董事长是哪里的？
[在 ssos (毛病不改添恶习) 的大作中提到：]
:傻逼
:脸肿了吧？
:☆ 发自 iPhone 买买提 1.24.07 |
w**********g
发帖数: 5486 | 10 高中生搜索引擎文盲，台巴电信诈骗饭政战队，lol你妈啊
[在 jeffff (bound) 的大作中提到：]
:浙江逼ok, lol
:....
:<br>: ssos？昨天抽你嘴巴，明目张胆造谣，现在换马甲
:<br> |
j****f
发帖数: 3552 | 11 傻逼浙江人
哈哈
【在 w**********g 的大作中提到】
: 高中生搜索引擎文盲，台巴电信诈骗饭政战队，lol你妈啊
: [在 jeffff (bound) 的大作中提到：]
: :浙江逼ok, lol
: :....
: :<br>: ssos？昨天抽你嘴巴，明目张胆造谣，现在换马甲
: :<br>
|
m********5
发帖数: 17667 | 12 所以我从来不喝自来水
烧汤都是用蒸馏水
【在 y****z 的大作中提到】
: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002984.jsp&mid=WC0b01ac058004d5c1
: EMA reviewing medicines containing valsartan from Zhejiang Huahai following
: detection of an impurity
: 05/07/2018
: EMA reviewing medicines containing valsartan from Zhejiang Huahai following
: detection of an impurity
: Some valsartan medicines being recalled across the EU
: The European Medicines Agency (EMA) is reviewing medicines containing the
: active substance valsartan that is supplied by Zhejiang Huahai
: Pharmaceuticals, a company in Linhai, China.
|
c**********r
发帖数: 44 | 13 靠，想起来上高中时买的一双皮鞋一个月就破了，里面露出纸板来。新衬衣洗一次衣领
就成了一坨，拆开才知道里面也有纸板。那会儿傻逼啥都不懂，但从那时起尽量不买浙
江人生产的东西。
【在 y****z 的大作中提到】
: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002984.jsp&mid=WC0b01ac058004d5c1
: EMA reviewing medicines containing valsartan from Zhejiang Huahai following
: detection of an impurity
: 05/07/2018
: EMA reviewing medicines containing valsartan from Zhejiang Huahai following
: detection of an impurity
: Some valsartan medicines being recalled across the EU
: The European Medicines Agency (EMA) is reviewing medicines containing the
: active substance valsartan that is supplied by Zhejiang Huahai
: Pharmaceuticals, a company in Linhai, China.
|
s*****e
发帖数: 522 | 14 改了生产工艺带来新的杂质，设个spec更新下DMF，再提供几个batch的结果应该就完事
了 |
