Probe into drug linked to deaths

Source: Xinhua/Shanghai Daily  |   2008-6-3  |     NEWSPAPER EDITION

CHINA'S drug regulator said yesterday it had found problems in some batches of the human immunoglobulin that has been linked to six deaths in Jiangxi Province.

Initial testing showed that some of the products had problems, but the cause was not yet identified, said Yan Jiangying, a spokeswoman for the State Food and Drug Administration.

She gave no details of the problems, but said further investigation was under way by a team dispatched from the administration. Local public security authorities were also looking into the case.

Six people died between May 22 and 28 at the No. 2 Hospital Affiliated with Nanchang University in Nanchang, capital of Jiangxi Province, after being given human immunoglobulin produced by Jiangxi Boya Bio-pharmaceutical Co, with batch number 20070514.

The drug administration has stopped sales and use of the human immoglobulin made by Boya and urged the manufacturer to recall products with the same batch number, while local authorities had sealed all the producer's human immunoglobulin.

No details of the victims are yet available and adverse drug reactions related to the same batch of drugs have not been reported elsewhere.

The Shanghai Food and Drug Administration said yesterday all local pharmaceutical-selling enterprises carried out checks and found that no local enterprises had purchased or sold the human immunoglobulin products produced by the Jiangxi company recently.

An inspection in the local market also found no trace of the product.

The Shanghai Clinical Center for Drug Adverse Reactions Monitoring said that it didn't receive any reports concerning the problem product.

Local FDA officials required residents to call the hotline 962727 whenever discovering the human immunoglobulin produced by the Jiangxi drug company.