其 他 安 全 警 示
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| Australia: The TGA intends to cancel all pain-killers containing dextropropoxyphene - Capadex, Di-Gesic, Doloxene and Paradex - from 1 March 2012 (English Only) |
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The TGA intends to cancel all pain-killers containing dextropropoxyphene - Capadex, Di-Gesic, Doloxene and Paradex - from the Australian Register of Therapeutic Goods (ARTG), from 1 March 2012. Dextropropoxyphene has recently been shown to affect the electrical activity of the heart, increasing the risk of serious arrhythmias (disturbances in the normal rhythm of the heart-beat). This effect is more pronounced with high doses or overdoses. An extensive review of the safety and efficacy of dextropropoxyphene has been conducted by the TGA. The review found that only limited pain relief is provided by the dextropropoxyphene in Capadex, Di-Gesic, Doloxene and Paradex, and that there are serious safety risks with the use of these medicines. The TGA has determined that the overall risk of serious adverse reactions outweighs any benefits that may be provided by these medicines. This position is consistent with medicine regulators in the United States, Europe, New Zealand and elsewhere, where dextropropoxyphene-containing medicines have been removed from the market. Capadex, Di-Gesic, Doloxene and Paradex will become unavailable for use. Alternative pain-relieving medicines are available. People using Capadex, Di-Gesic, Doloxene or Paradex should plan with their doctor to move to alternative pain relief well before 1 March 2012.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/newsroom/media-2011-dextropropoxyphene-111122.htm
In Hong Kong, the issue has been discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board on 29 December 2010. The Committee decided that, from January 10, 2011, all pharmaceutical products containing propoxyphene (in the form of dextropropoxyphene) should be deregistered for public health protection.
Ends/ Wednesday, November 23, 2011
Issued at HKT 17:30
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