华海原料药缬沙坦中检测出可能人类致癌物，欧盟监管部门启动召回相关药品

beiwei5du

EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of an impurity

05/07/2018

EMA reviewing medicines containing valsartan缬沙坦 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)N-二甲基亚硝胺, 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 substancemanufactured 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.
  
  

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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.

老道

最新公告，国内召回使用华海原料的制剂

beiwei5du

老道 发表于 2018-7-13 14:31
最新公告，国内召回使用华海原料的制剂

这样才是负责任的企业，望华海能挺过这次难关越来越好！！！

yc20160802

beiwei5du 发表于 2018-7-6 20:26
The presence of NDMA was unexpected and is thought to be related to changes in the way the active s ...

可能在化学合成工艺中使用有机溶剂二氯甲烷，给产品带来 N-nitrosodimethylamine (NDMA)N-二甲基亚硝胺

beiwei5du

The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.
有这种可能吗？？

beiwei5du

不知道CNDA如何反应呢？？

beiwei5du

发现杂质，欧洲市场召回华海药业缬沙坦
2018/07/06 中国 政策及规章
欧洲药品管理局（EMA）宣布，正在对中国浙江华海药业有限公司（“华海药业”）生产的含有活性药物成分（API）的缬沙坦片仿制药进行审查。起因是该公司发现原料药生产过程变化导致活性物质中出现了某种杂质。该杂质名为N-亚硝基二甲胺（NMDA），是一种对肝脏有毒的物质和人类致癌物质，也用于出于研究目的使大鼠患上癌症。
与此同时，欧盟有关监管部门在召回由浙江华海供应含有缬沙坦的药物。 此次审查将确定受影响产品中NDMA的水平，对使用此类产品的患者可能产生的影响，以及提出解决该公司存在问题的措施。
缬沙坦片（商品名：Diovan）的原研厂商为诺华，该药广泛用于治疗高血压，心力衰竭或近期心脏病发作的患者。 华海药业的仿制药于2015年6月获得美国批准上市，并于今年6月获得国家药监局批准上市（使用与境外相同的生产线）。目前华海药业还没有官方回应，因此该事件对相关市场的影响尚不明朗。

zysx01234

那情况不妙，美国马上相应了，

syhorchid

检出致癌物，事儿可不小。

793295036

麻烦大了！

blueangelhui

检测出基毒水平，但是控制在合理限度的话应该可以接受的吧？

beiwei5du

zysx01234 发表于 2018-7-6 23:08
那情况不妙，美国马上相应了，

应该是华海自己检测后主动通告的，后面继续跟进相关信息。
昨天晚上华海不是发了一个申明的吗。

kslam

情况严重程度可以从股票行情看出来。股价下跌约7％。


7月6日华海药业股票行情。

kent8145

不必大惊小怪，应该没事的吧

wsx

改变工艺？清洁不彻底？  国内产品有没有这个杂质？

M_IY2o0

yc20160802 发表于 2018-7-7 08:00
可能在化学合成工艺中使用有机溶剂二氯甲烷，给产品带来 N-nitrosodimethylamine (NDMA)N-二甲基亚硝胺

厉害了。。。。。。！！！！

长者叫我来巡山

N-Nitrosodiethylamine属2A类致癌物。2A类致癌物：对人类致癌性证据有限，对实验动物致癌性证据充分。同属2A类致癌物还有：阿霉素、雄激素（合成代谢）类固醇、生物质燃料（主要是木材）,家用燃烧排放的废物、氯霉素、草甘膦、涉及昼夜节律紊乱的转变等

M_IY2o0

长者叫我来巡山 发表于 2018-7-7 11:29
N-Nitrosodiethylamine属2A类致癌物。2A类致癌物：对人类致癌性证据有限，对实验动物致癌性证据充分。同属2 ...

还有65℃以上的热饮，不能喝汤，哈哈

beiwei5du

Decel Pharma and Accord Healthcare两家的制剂中是使用的华海的原料药缬沙坦，7月5日是被定义的Class 1 Recall。

Class 1 Medicines Recall: Action Now – including out of hours Pharmacy Level Recall

beiwei5du

保加利亚药监部门BDA针对于该可能致癌物召回62种药品
6 July 2018 | 16:07 | FOCUS News Agency
Bulgarian Drug Agency recalls 62 drugs after impurities that may cause cancer were foundPicture: AFP

Sofia. The Bulgarian Drug Agency (BDA) is recalling 62 high blood pressure and heart failure drugs after an impurity that may cause cancer was found in them, BDA said in a press release.
The European Medicines Agency (EMA) and national authorities have been informed of an impurity detected in the active substance valsartan manufactured by Zhejiang Huahai Pharmaceuticals, a company in China. The impurity - N-nitrosodimethylamine (NDMA) - is classified as a probable human carcinogen. The presence of NDMA is thought to be related to a change in the process for making valsartan.
The EMA and the national regulators are working together to investigate the extent of the issue and their potential impact on patients.
Meanwhile, as a precaution, the BDA has recalled medicines containing the active substance valsartan supplied by Zhejiang Huahai.
List of the recalled medicines:
1 Valsavil AM 5 mg/80 mg film-coated tablets
2 Valsavil AM 5 mg/160 mg film-coated tablets
3 Valsavil AM 10 mg/160 mg film-coated tablets
4 Valtensin 320 mg film-coated tablets
5 Valtensin 80 mg film-coated tablets
6 Valtensin 160 mg film-coated tablets
7 Valstor 160 mg film-coated tablets
8 Co-Valstor 160 mg/12,5 mg film - coated tablet
9 Valsalen 160 mg film-coated tablets
10 Valsalen H 160 mg/12,5 mg film-coated tablets
11 Valsalen H 160 mg/25 mg film-coated tablets
12 Valsarcon 160 mg film-coated tablets
13 Valsarcon 320 mg film-coated tablets
14 Sarteg 40 mg film-coated tablets
15 Sarteg 80 mg film-coated tablets
16 Sarteg 160 mg film-coated tablets
17 Sarteg HCT 80 mg/12,5 mg film-coated tablets
18 Sarteg HCT 160 mg/12,5 mg film-coated tablets
19 Sarteg HCT 160 mg/25 mg film-coated tablets
20 Valtensin Plus 80 mg/12.5 mg film-coated tablets
21 Valtensin Plus 160 mg/12.5 mg film-coated tablets
22 Valtensin Plus 160 mg/25 mg film-coated tablets
23 VAPRESS 80 mg film- coated tablets
24 VAPRESS 160 mg film-coated tablets
25 Vamadrid 40 mg film-coated tablets
26 Vamadrid 80 mg film-coated tablets
27 Vamadrid 160 mg film-coated tablets
28 Vamadrid 320 mg film-coated tablets
29 Suvartar 160 mg film-coated tablets
30 VALZAP 160 mg film- coated tablets
31 Valsavil 40 mg film-coated tablets
32 Valsavil 80 mg film-coated tablets
33 Valsavil 160 mg film-coated tablets
34 VALZAP H 160 mg/12,5 mg film-coated tablets
35 Asbima 5 mg/800 mg film-coated tablets
36 Asbima 5 mg/160 mg film-coated tablets
37 Asbima 10 mg/160 mg film-coated tablets
38 Bevacomb 5 mg/160 mg film-coated tablets
39 Bevacomb 10 mg/160 mg film-coated tablets
40 Sartesta 5 mg/80 mg film-coated tablets
41 Sartesta 5 mg/160 mg film-coated tablets
42 Sartesta 10 mg/160 mg film-coated tablets
43 Valtensam 5 mg/160 mg film-coated tablets
44 Valtensam 10 mg/160 mg film-coated tablets
45 Valsavil Comp 80 mg/12,5 mg film-coated
46 Valsavil Comp 160 mg/12,5 mg film-coated
47 Suvartar H 160 mg/12,5 mg film-coated tablets
48 Suvartar H 160 mg/25 mg film-coated tablets
49 Valtensin plus 320 mg/12.5 mg film - coated tablets
50 Co-Sartroval 160mg/25mg film-coated tablets
51 Nortivan Neo 160 mg film-coated tablets
52 Nortivan 80 mg film-coated tablet
53 Nortivan 40 mg film-coated tablets
54 Vanatex HCT 80 mg/12.5 mg film - coated tablets
55 Vanatex HCT 160 mg/25 mg film - coated tablets
56 Vanatex 80 mg film - coated tablets
57 Vanatex 160 mg film - coated tablets
58 Valsol plus160 mg/25 mg film-coated tablets
59 Valsavil Comp 80 mg / 12,5 mg film - coated tablets
60 Valsavil Comp 160 mg / 12,5 mg film - coated tablets
61 Valtensin plus 320 mg/25mg film - coated tablets
62 Valsargamma 160mg film-coated tablets

beiwei5du

香港健康监管部门对涉嫌的5种药品进行召回

Hong Kong health department issues recall for five heart drugs containing valsartan that was made in China

An estimated 30,000 people could be affected by recall of pharmaceuticals used to treat hypertension and heart failure
PUBLISHED : Friday, 06 July, 2018, 11:16pm
UPDATED : Friday, 06 July, 2018, 11:35pm

Hong Kong’s Department of Health on Friday recalled five prescription drugs that are used to treat heart disease because they have the potential to cause cancer.

An estimated 30,000 people could be affected by the recall of the valsartan-containing drugs, which are prescribed to treat hypertension and heart failure.

The health department instructed wholesalers Actavis Hong Kong Limited and Hong Kong Medical Supplies Limited to recall the medicine from the market after an impurity – N-nitrosodimethylamine (NDMA) – was found in the valsartan, which was produced by a company in mainland China.

NDMA is classified as a probable carcinogen in humans.

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The affected products are Valtensin 160mg tablets, Valtensin 80mg tablets, Valtensin HCT tablets 160/12.5mg, Valtensin HCT tablets 80/12.5mg, and Valsartan Stada 80mg tablets. Four drugs were registered by Actavis with one registered by Hong Kong Medical Supplies.

Actavis HK and HK Medical Supplies confirmed the products registered in Hong Kong contained the affected material. According to the two wholesalers, the affected products have been supplied to private doctors and pharmacies. The Valtensin 80mg and 160mg tablets have also been supplied to the Hospital Authority.

The Hospital Authority said all public hospitals had been notified to stop prescribing the drugs.

“There are currently around 30,000 patients in public hospitals being dispensed with the anti-hypertensive drug concerned. Their condition will be reviewed by the attending doctor when they attend their next follow-up consultation at the clinic,” a spokesperson said.

Full screening for superbug begins as hospitals battle rising number of cases

The health department said patients should continue taking the drug, but should consult their doctor.

William Chui Chun-ming, president of the Society of Hospital Pharmacists of Hong Kong, agreed, saying the authority was still investigating the amount of contamination to “balance the risk and benefit”.

“The medicines in question are commonly used in the public [medical] sector for high blood pressure and heart failure, which means sudden cease of consumption may lead to fatal implications because uncontrolled high blood pressure can result in stroke, renal failure and acute vascular diseases,” Chui said.

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Cardiologist Dr Bernard Wong Bun-lap said patients should consult their doctors as soon as possible and seek to changing medicine.

“The chance of contracting cancer is related the amount of carcinogen, as well as the patients’ physical condition. Patients are advised to use other medicines under doctors’ instructions no matter how much NDMA it takes to give them cancer,” Wong said.

Wong added that the medicine in question have been widely used in public hospitals because they were cheaper versions of the drug.

“One pill from the original factory can cost HK$6 [US$0.75] or more than HK$10, while those produced by other factories – mostly in developing countries – can be priced under HK$1 each,” Wong said.

Both companies have set up hotlines (Actavis: 3188 4288; HK Medical: 2806 3112) to answer related inquiries.

beiwei5du

诺华的供应商是华海吗?

Commonly prescribed heart drug is recalled in 22 countries
POSTED 6:37 PM, JULY 6, 2018, BY CNN WIRE

A common drug used to control blood pressure and help prevent heart failure is being recalled in 22 countries because it contains a chemical that poses a potential cancer risk.

Valsartan is off-patent and is used as a component of other generic medicines. Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan/HCT film-coated tablets are being recalled since they “do not meet our high quality standards.” Pharmacies in the UK are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare.

The recall involves about 2,300 batches that were sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.

Novartis spokesman Eric Althoff said that products sold in the United States are not affected by this recall. The US Food and Drug Administration says it is looking to see whether it “has any information to share at this time” and directed questions to the manufacturer, as it is “the best source of information about their product.”

The problem was discovered during tests of batches of valsartan’s active pharmaceutical ingredient (API), as those from an external supplier contained an impurity. The European Medicines Agency reviewed medicines from the supplier, Zhejiang Huahai Pharmaceuticals in Linhai, China. The agency said the impurity is “a result of a change in the manufacturing process.”

The impurity is N-Nitrosodimethylamine (NDMA), an organic chemical that is in a family of potent carcinogens. The chemical has been used to make liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.

Animal studies have shown that NDMA can be toxic and cause tumors in the liver, kidney and respiratory tract. It can also be potentially harmful to humans in certain quantities. Exposure to high levels can cause liver damage and is a probable human carcinogen, according to the US Department of Health and Human Services.

“The amounts of NDMA found in Valsartan API are much lower than the cumulative endogenous production and usual external exposure of NDMA,” Althoff wrote in an email. “There is no certainty as to how much this contaminant may potentially increase cancer risk in humans. Thus, the amount of NDMA found in the Valsartan API would not represent a significantly increased risk to the patients taking of Sandoz Valsartan and Sandoz Valsartan HCT Film coated tablets.”

The European Medicines Agency and EU regulators are working to determine what impact this might have on patients and whether other drugs will be affected. The external supplier is used by other pharmaceutical companies, as well, according to Novartis’ statement, but the spokesman said it could not comment on those companies. The company says that no other Sandoz or Novartis products, even those that may contain valsartan, are affected by the recall.

“We continue to undertake an urgent review of all these products that may pose a low risk to public health,” said Dr. Sam Atkinson, director of the UK Medicines and Healthcare products Regulatory Agency’s Inspection, Enforcement and Standards Division.

Novartis said that although the amount of the NDMA in the drug isn’t considered a “significantly increased risk to the patients,” patients should talk with their doctors to discuss treatment options as a precaution.

Patients shouldn’t stop taking their medicine, but the Medicines and Healthcare products Regulatory Agency said it is vital that they get in touch with their doctors “as soon as possible.” Alternative medicines that are unaffected by the recall are available.

“They key with this is, patients should not stop taking their medication abruptly, that definitely can be harmful,” said Dr. Mary Ann Bauman a representative for the American Heart Association. “You don’t want to jump to any conclusions on your own about this medication, or any medication for that matter. Definitely talk with your doctor first.”

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