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Drug maker shuts after shots sicken patients
Source: Xinhua |
May 26, 2009, Tuesday
|
Print Edition
Print Edition
A DRUG producer in northwest China has been shut down temporarily while authorities investigate claims that its herbal injection caused chills and high fever in some patients, local drug regulators said yesterday.
Wang Yongli, spokesman for the Food and Drug Administration of Shaanxi Province, said Xi'an Jiahui Pharmaceutical Co Ltd voluntarily closed so that an investigation could be conducted into Shenkang, an injection it produced to treat chronic renal failure.
After receiving injections, 23 patients at the No.2 Hospital of the Tianjin Medical University in north Tianjin City experienced chills and high fever, said Song Ligang, head of the Center for Adverse Drug Reaction Monitoring of Tianjin. All received prompt treatment and reported they were feeling better in four to six hours, said Song. The cases began on May 11.
The Tianjin Institute for Drug Control said two batches of the drug tested positive in a pyrogen reaction test. Pyrogen reactions include chills, vomiting, high fever and falling blood pressure. Severe reactions can be fatal.
Tianjin suspended the use of the drug on May 22. Cities and provinces including Beijing, Liaoning and Jilin also issued notices to hospitals, urging them to watch out for adverse reactions.
Initial investigation showed that the pharmaceutical company was not involved in illegal production, and the investigation would center on possible technical problems, said Wang.
Two batches have already been recalled. All the injections on the market will now be recalled, said Wang.
Wang Yongli, spokesman for the Food and Drug Administration of Shaanxi Province, said Xi'an Jiahui Pharmaceutical Co Ltd voluntarily closed so that an investigation could be conducted into Shenkang, an injection it produced to treat chronic renal failure.
After receiving injections, 23 patients at the No.2 Hospital of the Tianjin Medical University in north Tianjin City experienced chills and high fever, said Song Ligang, head of the Center for Adverse Drug Reaction Monitoring of Tianjin. All received prompt treatment and reported they were feeling better in four to six hours, said Song. The cases began on May 11.
The Tianjin Institute for Drug Control said two batches of the drug tested positive in a pyrogen reaction test. Pyrogen reactions include chills, vomiting, high fever and falling blood pressure. Severe reactions can be fatal.
Tianjin suspended the use of the drug on May 22. Cities and provinces including Beijing, Liaoning and Jilin also issued notices to hospitals, urging them to watch out for adverse reactions.
Initial investigation showed that the pharmaceutical company was not involved in illegal production, and the investigation would center on possible technical problems, said Wang.
Two batches have already been recalled. All the injections on the market will now be recalled, said Wang.
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