Patients critically ill after immunoglobulin shot
Updated: 2008-06-05 23:44
NANCHANG - An investigation into six deaths linked to injections of human immunoglobulin in the eastern province of Jiangxi has found that five patients were critically ill when they received the shots late last month.
The deaths of the five patients at the No. 2 Hospital affiliated with Nanchang University did not arouse the attention of doctors at the very beginning, because the patients were all in critical conditions -- either with malignant tumors or immune deficiency syndromes, a spokesman for the investigation team said.
Also, doctors said the five patients had been treated in different departments and received injections at different times, the spokesman said.
Doctors did not make a connection between the drug and the adverse reactions until the sixth death, after giving the same injection to a patient who was "in good condition." They immediately reported the incident to the provincial drug authorities, he said.
The seventh patient, a boy, also had severe adverse reactions after being injected with the same batch of human immunoglobulin late in May. He survived following an emergency operation.
The investigation was continuing.
As of Thursday noon, no more cases had been reported, local authorities said.
All the human immunoglobulin of the same batch produced on May 14 had been traced nationwide, said a provincial Food and Drug Administration official on Thursday.
According to statistics, the producer sold 9,575 bottles of the batch. As of late Thursday, 3,328 bottles had been used, in which 349 were for the investigation. The government had also withdrawn 6,247 bottles.
The six people died between May 22 to 28 at the hospital in the provincial capital of Nanchang after being given human immunoglobulin from the same batch produced by the Jiangxi Boya Bio-pharmaceutical Co. Ltd.
Jiangxi Boya, founded in Fuzhou City in 1994, produced 9,575 doses of human immunoglobulin in batch number 20070514, or the "problematic" batch, of which 3,192 shots had been sold and used. The rest had been recalled and sealed under orders of the State Food and Drug Administration and Ministry of Health.
The two agencies suspended the sale and use of all immunoglobulin manufactured by Jiangxi Boya.
Shao Mingli, head of the State Food and Drug Administration, was in Jiangxi to oversee the investigation.
Local public security authorities were also looking into the case.
A company spokesman told Xinhua it had not received other reports of adverse reactions related to the same batch of drugs.
Human immunoglobulin is a protein produced from human plasma cells and lymphocytes, and plays an essential role in the immune system. It attaches to foreign substances, such as bacteria, and assists in destroying them.
The drugs are commonly used to treat auto-immune diseases such as newborn sepsis, idiopathic thrombocytopenic purpura and Kawasaki disease.
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