China Recalls Ginseng Injections After 3 Deaths

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Main Category: Regulatory Affairs / Drug Approvals
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Article Date: 10 Oct 2008 - 0:00 PDT

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A chinese pharmaceutical firm recalled batches of ginseng herbal injections after three people given the treatments died, said a local authority announcement on Thursday in Kunming in southwestern Yunnan Province of China.

According to China state news agency Xinhua, the Yunnan Provincial Health Department said the two recalled batches of "ciwujia" (a type of Siberian ginseng) injections have been tested and no toxins were found. Experts from the Ministry of Health tested 180 samples from the two batches but found no toxins, for example rodent poison, pesticides or herbicides, although further investigations are still ongoing, they said.

The region affected is mainly populated by the Hani and Yi ethnic people. The local Public Security Bureau of Honghe Autonomous Prefecture said there was no evidence that someone had intentionally tampered with the product to insert toxins in the medicine.

The injections were recalled by the manufacturer, Wandashan Pharmaceutical based in northeastern Heilongjiang Province, in December, following reports that three people who had been treated with them had died.

Guo Laibin, a Heilongjiang Land Reclamation Region official in charge of economic development said at a press conference that:

"We started on Tuesday morning to recall the products that had been sold by the company but not used by hospitals."

"All the medicine is on the way back," he added, but did not say how many doses were involved.

6 patients in the No 4 People's Hospital of the Honghe Autonomous Prefecture experienced serious adverse reactions, including vomiting and becoming comatose after receiving injections from the affected batches of ciwujia. Three of them died on Monday, and the other three are stable but under observation.

Guo said officials from state, province and city food and drug administrations started investigations at the manufacturing plant on Tuesday night, but gave no details of how they were progressing, apart from commenting that "the heads of the company are cooperating with the investigation".

Meanwhile sales and use of the drug have been suspended and all hospitals instructed to monitor patients for possible adverse reactions, said Li Bin, head of the Heilongjiang health bureau.

The problem is thought to be confined to Yunnan, as the State Food and Drug Administration has not received reports outside of the province.

The manufacturer at the centre of the crisis, Wandashan Pharmaceutical, has been trading for over 30 years and employs 570 workers.

In China, siberian ginseng by injection is used to treat thrombosis caused by weak liver and kidneys, coronary heart disease, nervous exhaustion and menopausal problems, said the Xinhua report.

Source: Xinhua.

Written by: Catharine Paddock, PhD.


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