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MOH Bans the Use of Hepatitis C-causing Blood Drug
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Chinese Ministry of Health on Wednesday banned the use of a blood-based drug which is believed to have infected users with hepatitis C.

Local health authorities must order all medical institutions to register patients who have used the drug, produced by Guangdong Bioyee Pharmaceutical Co. Ltd., said the ministry in an urgent statement.

Those who have used the intravenously administered drug must be given blood tests for hepatitis C nucleic acid and antibodies, and should be put under close observation.

"Immediate measures must be taken if the patients show abnormal symptoms," said the ministry.

China has suspended the production and sale of the drug, which is an extract of human blood, after people being treated with it tested positive for hepatitis C antibodies.

The drug has been sold in 12 provinces and cities -- Beijing, Hebei, Heilongjiang, Jiangsu, Zhejiang, Anhui, Fujian, Hunan, Guangdong, Guangxi, Chongqing and Sichuan, according to the ministry.

Almost 90,000 doses of the drug have been recalled, according to the State Food and Drug Administration (SFDA).

In Beijing 68,558 bottles of the drug have been recalled, along with 20,000 bottles in Guangdong province.

The authorities did not reveal how many people taking the drug had been infected with hepatitis C antibodies.

The drug is made from donated human blood and used to boost the users' immune systems. Doctor Jia Jidong, of the Beijing Friendship Hospital, said not everyone with hepatitis C antibodies would fall ill with the disease.

He estimated that about 50 to 85 percent of those tested positive for antibodies would end up contracting the disease.

Jia said it could take up to eight weeks for symptoms to appear.

Ministry spokesman Mao Qun'an said local hospitals would keep a close eye on patients who received the drug made from human immunoglobulin, proteins that behave like antibodies.

The SFDA said the company was unable to provide a record of production and testing of the drug.

On Jan. 16, the Health Ministry announced it was revoking the manufacturing certificates of the Bioyee and Haikou Kangliyuan Group. Both were found to be violating production standards following an investigation last December.

Jia said that if the company had followed proper manufacturing procedures, the hepatitis C antibodies would have been killed and users would not have been infected.

Hepatitis C is a liver disease and although symptoms are relatively mild compared with other types of hepatitis, it can become chronic and lead to liver cancer.

According to the national Center for Disease Control and Prevention (CDC), 40 million Chinese carry the hepatitis C virus. The number of new cases jumped to about 60,000 in 2005 from 20,000 in 2003.

(China Daily January 25, 2007)

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