Chinese Ministry of Health on Wednesday banned the use of a
blood-based drug which is believed to have infected users with
Local health authorities must order all medical institutions to
register patients who've used the drug, produced by Guangdong
Bioyee Pharmaceutical Co. Ltd., said the ministry in an urgent
Those who have used the intravenously administered drug must be
given blood tests for hepatitis C nucleic acid and antibodies and
placed 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 -- an
extract of human blood -- after people being treated with it tested
positive for hepatitis C antibodies.
The drug has been used in 12 provinces and cities -- Beijing,
Hebei, Heilongjiang, Jiangsu, Zhejiang, Anhui, Fujian, Hunan,
Guangdong, Guangxi, Chongqing and Sichuan, according to the
Almost 90,000 doses have been recalled, said the State Food and
Drug Administration (SFDA). In Beijing 68,558 bottles of the drug
have been recalled and 20,000 in Guangdong Province. The authorities didn't
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. It could take up to eight weeks for symptoms to
Ministry spokesman Mao Qun'an said local hospitals would keep a
close watch 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 January 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 off
and users would not have been infected.
Hepatitis C is a liver disease and although symptoms are
relatively mild compared with other forms of hepatitis it can
become chronic and lead to liver cancer.
According to the national Center for Disease Control and
Prevention, 40 million Chinese carry the hepatitis C virus. The
number of new cases jumped to approximately 60,000 in 2005 from
20,000 in 2003.
(Xinhua News Agency January 25, 2007)