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China Orders Disuse of Drug Causing Clinical Symptoms

The Chinese Ministry of Health issued an urgent circular ordering the disuse of a problematic injection medicine used to treat bacteria infections, which probably has caused at least one death.

A six-year-old girl from Harbin, the capital of northeast China's Heilongjiang Province, was reportedly killed from having been mainlined with this problematic antibiotics known as clindamycin phosphate glucose injection.

An increasing number of patients from provinces and regions including Qinghai, Guangxi, Zhejiang, Heilongjiang and Shandong have complained about symptoms ranging from chest distress, pain in the kidney of the body, bellyache, diarrhea, nausea, vomit, to anaphylactic shock after having been injected with the clindamycin phosphate glucose injections produced by the Anhui company.

The dead, identified as Liu Sichen, had an intravenous injection of the clindamycin phosphate at about 2 PM on July 27 for common cold, but she developed symptoms including high fever within 20 minutes, according to Sun Pengli, director of Pharmaceuticals Side Effects Monitoring Center of Harbin City, on Friday.

The clindamycin phosphate glucose injection mainlined into the girl patient was known to be produced by Anhui Huayuan Worldbest Biology Pharmacy Co., a subsidiary of Shanghai Worldbest Co.Ltd., with a batch number of 06062602.

The patient was soon transferred to the State Farm General Hospital of Heilongjiang Province for further rescue operation. The girl remained in a coma.

She was again transferred to the No.2 Hospital of the Harbin Medical Sciences University, but was proclaimed dead at the night of July 27 despite all rescue efforts by medical workers.

"Based on all materials we have gathered, a preliminary judgment can be made that the girl was killed due to the injection of the clindamycin phosphate glucose produced by the Anhui Huayuan Worldbest Biology Pharmacy Co.," said Sun Pengli.

The Ministry of Health demanded that all batches of clindamycin phosphate glucose injections produced in the past two moths by Anhui Huayuan Worldbest Biology Pharmacy Co. be suspended from use immediately.

Fake of bad drugs have killed dozens of people in China in recent years and raised questions about drug safety.

The country has recently fined Qiqihar No.2 Pharmaceutical Co. Ltd. and revoked its licence after its drug meant to treat gastric disorders killed 11 people and turned out to be bogus.

Anhui Huayuan Worldbest Biology Pharmacy Co., has been told by the Anhui Provincial Food and Drug Bureau to halt production at the injection workshop and to cooperate with the special groups in the investigative effort.

According to a spokesman for the provincial food and drug bureau, several groups have stationed at the Anhui Huayuan Worldbest Biology Pharmacy Co., doing investigations there.

"The production can not be resumed until a clear outcome is out about the fuss," said the spokesman.

A recall of the problematic drug is also underway.

While ordering that an inventory be made into the stockpile of the injections and all unused injections be sealed properly, the ministry circular also asked medical and health organizations not to purchase the injections made by the above-mentioned company.

In the meantime, the circular also told medical organizations to arrange medical workers to closely monitor patients who have had the injections and go all out to rescue those patients who have shown serious clinical symptoms.

Clindamycin phosphate glucose injections are mainly used to treat bacteria infections caused by gram-positive bacterium and gram-positive anaerobic bacterium. Side effects are mainly restricted to the gastrointestinal tract and anaphylactic reaction, sometimes coupled with abnormalities with the liver and kidney body parts.

(Xinhua News Agency August 4, 2006)
 

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