Recall of blood pressure drugs containing cancer-causing impurity finished in China, says involved drug maker-Sino-US


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Recall of blood pressure drugs containing cancer-causing impurity finished in China, says involved drug maker
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A Chinese pharmaceutical company that had previously reported “unexpected impurity” in its top seller ingredient drug treating high blood pressure said on Monday that all batches containing the probable cancer-causing impurity had been recalled from the domestic market by July 23.

The listed company, Zhejiang Huahai Pharmaceuticals which sells generic drugs also to overseas markets including Europe and the United States reportedly initiated voluntary recall procedures on both overseas and domestic markets during mid-July.

It published a statement on Monday, disclosing names of all the six domestic drug producers sourcing from it the problematic active ingredient valsartan while claiming all problematic drugs had been fully recalled by July 23, reported thepaper.cn, a Shanghai-based news portal.

The State Drug Administration confirmed what Zhejiang Huahai said. The State Council-sponsored Economic Daily cited SDA spokesman as saying that regulators at provincial levels had spared no efforts in urging and helping the six involved drug producers make the recall.

Zhejiang Huahai also cautioned users of valsartan medicine not to stop medication arbitrarily citing reason that the act would inflict more direct and severe harm on high blood pressure patients. It suggests drug users to first divert to other alternatives free of the dangerous impurity.

It’s earlier reported that Zhejiang Huahai detected the existence of the impurity, known to be N-Nitrosodimethylamine (NDMA), a human carcinogen on June 15. The company thus suspended Valsartan’s sales in both domestic and foreign markets and then reported the situation to the State Drug Administration on July 6.

According to Zhejiang Huahai, the “traces of unexpected impurity” was generated by the current manufacturing technique which it emphasized is approved by relevant drug administration agencies and in compliance with safety and regulatory standards. 
One thing notable is that the drug maker changed its valsartan production technique to the current one in 2012.

According to the State Drug Administration’s statement, the NDMA impurity detected in Zhejiang Huahai’s valsartan ingredient has gone beyond limit. They thus implemented inspections on all the other domestic valsartan suppliers and found out NDMA impurity could either not be detected or maintained within the limit.

Established in 1988, Zhejiang Huahai got listed on the Shanghai Stock Exchange in 2003. By July 27, the company’s market value stood at 26 billion yuan.

Shi Lichen, the founder of msikl.com, an online medical service platform was cited by Chinese media as saying although Zhejiang Huahai has voluntarily recalled problematic medicines, it still need to answer the question: why is that ingredient valsartan produced by other pharmaceutical companies following the same production standards is free of the probable cancer-causing impurity?

Shi suggested the previous batches of the company’s medicine could also be tainted and it is supposed to make sure the problem with its manufacturing process be found out and solved. Till now, Zhejiang Huahai merely said in its statement that it would try to decrease the level of the toxic substance below the limit amount.

The State Drug Administration said it has been maintaining close communication and contact with their counterparts in Europe and the United States while inviting experts to evaluate risks posed, since being reported about the urgency on July 6. 

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