Published on ShanghaiDaily.com (http://www.shanghaidaily.com/)
http://www.shanghaidaily.com/sp/article/2008/200806/20080603/article_361798.htm
Regulators seize human protein linked to 6 deaths
Created: 2008-6-3 11:35:35
Author:Li Xinran
THE protein human immunoglobulin has been seized by drug regulators after problems were found in test samples at a pharmaceutical company in Jiangxi Province, Beijing News reported today.
The substance has been linked to six deaths in the province.
A preliminary sample test showed that some of the products had problems, but the reason was still unidentified, Yan Jiangying, spokeswoman of the State Food and Drug Administration, said yesterday. Police have launched an investigation, Yan added.
The State Food and Drug Administration dispatched a task force to Jiangxi on Thursday after receiving reports that the drug had been linked to six deaths.
Six people died between May 22 and 28 at No. 2 Hospital Affiliated with Nanchang University in Nanchang, capital of Jiangxi, after being given human immunoglobulin that was produced by Jiangxi Boya Bio-pharmaceutical Co. The batch number was 20070514.
However, no other reports of adverse reactions have been received since May 28, the newspaper said.
The administration and its branches across the country have sealed human immunoglobulin products made by Jiangxi Boya and urged the manufacturer to recall products with the same batch number.
The deaths aroused the hospital's attention because one leukemia patient was in stable condition, but died suddenly after being given a human immunoglobulin injection.
The hospital reported to the drug authority in Jiangxi on May 28.
Test results were expected in 15 days, said the Jiangxi drug authority and the hospital yesterday.
The hospital reportedly purchased two batches of human immunoglobulin this year. No side-effects were reported with the first batch of 300 pieces purchased in March.
Human immunoglobulin is a protein produced from human plasma cells and lymphocytes. It plays an essential role in the body's immune system. The protein attaches itself to foreign substances such as bacteria and assists in destroying them.
The substance has been linked to six deaths in the province.
A preliminary sample test showed that some of the products had problems, but the reason was still unidentified, Yan Jiangying, spokeswoman of the State Food and Drug Administration, said yesterday. Police have launched an investigation, Yan added.
The State Food and Drug Administration dispatched a task force to Jiangxi on Thursday after receiving reports that the drug had been linked to six deaths.
Six people died between May 22 and 28 at No. 2 Hospital Affiliated with Nanchang University in Nanchang, capital of Jiangxi, after being given human immunoglobulin that was produced by Jiangxi Boya Bio-pharmaceutical Co. The batch number was 20070514.
However, no other reports of adverse reactions have been received since May 28, the newspaper said.
The administration and its branches across the country have sealed human immunoglobulin products made by Jiangxi Boya and urged the manufacturer to recall products with the same batch number.
The deaths aroused the hospital's attention because one leukemia patient was in stable condition, but died suddenly after being given a human immunoglobulin injection.
The hospital reported to the drug authority in Jiangxi on May 28.
Test results were expected in 15 days, said the Jiangxi drug authority and the hospital yesterday.
The hospital reportedly purchased two batches of human immunoglobulin this year. No side-effects were reported with the first batch of 300 pieces purchased in March.
Human immunoglobulin is a protein produced from human plasma cells and lymphocytes. It plays an essential role in the body's immune system. The protein attaches itself to foreign substances such as bacteria and assists in destroying them.
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