Reuters Health Information (2007-01-24): China stops blood drug over hepatitis C fears
China stops blood drug over hepatitis C fears
Last Updated: 2007-01-24 11:00:22 -0400 (Reuters Health)
BEIJING (Reuters) - China has suspended the production and sale of an intravenously injected blood-based drug used to treat immune system deficiencies after users were feared to have contracted hepatitis C.
China's Health Ministry and drug watchdog, the State Food and Drug Administration, said that the Guangdong Bioyee Pharmaceutical Co. Ltd. had committed "illegal behaviour" in the production of its immunoglobulin drug and that users had tested positive to "Hepatitis C antibodies".
"Experts confirmed a link between this and the problematic products," the notice posted on the State Food and Drug Administration Web site said.
Investigations by health authorities had found that some of the products lacked proper production and inspection records, the notice said.
The notice called on hospitals to track down patients who had used the drug and urged patients who developed adverse reactions to "adopt measures" immediately.
Hepatitis C can lead to chronic liver infection and cirrhosis. About 1 percent to 5 percent of people with the disease eventually dies from long-term infection, according to the U.S. Centers for Disease Control and Prevention.
Fake or tainted drugs have killed dozens in China in recent years and sparked public fury about drug safety. Chinese media have blamed frequent scandals on businesses chasing profits and lax official supervision.
The Health News, a newspaper run by China's Health Ministry, quoted experts as saying that the plasma used to make the immunoglobulin drug might have contained either the hepatitis C virus or its antibodies.
It would take two to eight weeks to rule out the chance of hepatitis C infections for the users, the newspaper said.
The reports did not say how many users had been affected by the drug or how many samples of the drug were problematic.
Guangdong health authorities had seized 21,470 problematic samples and authorities in western Sichuan province had returned or seized over 1,000 bottles of the drug, the Beijing News said on Wednesday.
Last October, the drug watchdog banned a company in eastern Anhui province from producing injected antibiotics to treat bacterial infections after the drug was linked to the deaths of six people.
In July, China fined another drug company in the northeastern province of Heilongjiang after its drug meant to treat gastric disorders killed 11 people.