Painkiller to be withdrawn
Source: Xinhua |
February 1, 2011, Tuesday
|
Print Edition
Print Edition
CHINA'S drug watchdog has ordered all medicines containing the painkiller dextropropoxyphene withdrawn from the market because of potentially life-threatening side effects.
A statement on the State Food and Drug Administration website yesterday said dextropropoxyphene, which has been in use for decades in China, had serious toxic side effects on the heart and could be fatal in high doses.
The administration said the decision was based on both domestic and overseas research results and the advice of domestic experts.
The withdrawal would be gradual to allow time for the safe transfer of patients to appropriate alternative therapies, said the statement.
All companies and institutions should stop producing, marketing or using medicines containing dextropropoxyphene from July 31, it said.
Dextropropoxyphene is available only in the form of prescription-only compound tablets in China and is usually used to treat slight or moderate pain, as well as pain caused by cancer.
The medicines containing it are produced by the Jiangsu Heng Rui Medicine Co Ltd and the China National Medicines Guorui Pharmaceutical Co Ltd in Anhui Province, the statement said.
Many countries had indicated concern over the safety of medicines containing dextropropoxyphene. The United Kingdom withdrew them in January 2005 and the United States Food and Drug Administration followed suit last November.
A statement on the State Food and Drug Administration website yesterday said dextropropoxyphene, which has been in use for decades in China, had serious toxic side effects on the heart and could be fatal in high doses.
The administration said the decision was based on both domestic and overseas research results and the advice of domestic experts.
The withdrawal would be gradual to allow time for the safe transfer of patients to appropriate alternative therapies, said the statement.
All companies and institutions should stop producing, marketing or using medicines containing dextropropoxyphene from July 31, it said.
Dextropropoxyphene is available only in the form of prescription-only compound tablets in China and is usually used to treat slight or moderate pain, as well as pain caused by cancer.
The medicines containing it are produced by the Jiangsu Heng Rui Medicine Co Ltd and the China National Medicines Guorui Pharmaceutical Co Ltd in Anhui Province, the statement said.
Many countries had indicated concern over the safety of medicines containing dextropropoxyphene. The United Kingdom withdrew them in January 2005 and the United States Food and Drug Administration followed suit last November.
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