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2nd Ld-Writethru: Herbal Injections Recalled After Three Deaths, No Toxins Found in Samples

October 10, 2008

2nd Ld-Writethru: Herbal injections recalled after three deaths, no toxins found in samples

HARBIN/KUNMING, Oct. 9 (Xinhua) — No toxins were found in two batches of the “ciwujia” herbal injections believed to have recently killed three people in southwest China’s Yunnan Province, local authorities said on Thursday in Kunming.

Experts dispatched by the Ministry of Health tested 180 samples from batches 2007121511 and 2007122721 of “Ciwujia Injection” but found no toxins, such as rodent poison, pesticide or herbicide, according to Yunnan Provincial Health Department. The medicine was extracted from ciwujia, a type of Siberian ginseng.

Further investigation was underway, it said, without giving details.

There was no indication someone would intentionally put toxins to the medicine, according to the Public Security Bureau of Honghe Autonomous Prefecture, mainly populated by the Hani and Yi ethnic people.

The problematic injections were produced in December by the Wandashan Pharmaceutical in northeastern Heilongjiang Province.

The firm recalled the two batches following the deaths of the three people given the treatments, local authorities said on Thursday.

“We started on Tuesday morning to recall the products that had been sold by the company but not used by hospitals,” said Guo Laibin, a Heilongjiang Land Reclamation Region official in charge of economic development, at a press conference. “All the medicine is on the way back.”

He declined to give the exact figure of the recalled medicine or how many doses were produced for each batch.

Six patients in the No. 4 People’s Hospital of the Honghe Autonomous Prefecture had strong adverse reactions, including vomiting and becoming comatose, after being injected with ciwujia from the two batches. Three died in hospital on Monday. The others were in stable condition but still needed observation.

“The ciwujia injections have been used for a long time in our hospital before and caused no problem,” said hospital president Liu Ru. “It was after Sunday’s use of the two different batches the incident occurred.”

In total, 19 people used the injections in the hospital. Six had adverse reactions.

Xue Yun, the Honghe Food and Drug Administration director, said 13 hospitals in the prefecture used the two batches of injections and only the No. 4 People’s Hospital had reported adverse reaction cases.

The administration officials found 180 bottles of the herbal formula left in the No. 4 People’s Hospital. All were sent to the authorities for examination.

The food and drug administrations of the state, provincial and city levels arrived at the Wandashan Pharmaceutical plant to investigate the medicine on Tuesday night, but gave no conclusions, Guo said.

“The heads of the company are cooperating with the investigation.”

The provincial food and drug watchdogs of Yunnan and Heilongjiang have ordered the suspension of sales and usage of the medicine.

All hospitals were ordered to closely monitor patients for possible adverse reactions, said Li Bin, Heilongjiang health bureau head.

To date, the State Food and Drug Administration (SFDA) had received no such reports from outside Yunnan.

Wandashan Pharmaceutical has more than 570 staff and has manufactured ciwujia for more than 30 years.

Siberian ginseng injections are often used to treat thrombosis caused by weak liver and kidneys. It is also believed to be helpful in treating coronary heart disease, nervous exhaustion and menopausal problems.

(c) 2008 Xinhua News Agency – CEIS. Provided by ProQuest LLC. All rights Reserved.




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