ADR that result in revision of patient information
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| Australia :Update on TGA decision to cancel prescription pain-killers |
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The TGA is providing updated information to the public and to health professionals about the regulatory status of dextropropoxyphene-containing pain-killers. On 5 April 2013 the Administrative Appeals Tribunal (AAT) handed down its decision in the appeal against the TGA's decisions to cancel dextropropoxyphene-containing products, Di-Gesic and Doloxene from the Australian Register of Therapeutic Goods (ARTG). The TGA had cancelled all pain killers containing dextropropoxyphene from the ARTG, effective from 1 March 2012 because it decided the safety of these medicines was unacceptable.
The AAT has concluded that, subject to the imposition of additional conditions and monitoring arrangements of a kind described by the AAT in its decision, the quality, safety and efficacy of both Di-Gesic and Doloxene are not unacceptable. Consequently, the products will remain on the ARTG. Negotiations on the conditions and monitoring arrangements will be held between the sponsor and the TGA prior to being imposed by the AAT.
A number of countries have withdrawn approval for dextropropoxyphene-containing products, including the United States, Canada, New Zealand, the United Kingdom, the European Union, Singapore and South Africa.
Please refer to the following website in TGA for details :
http://www.tga.gov.au/newsroom/media-2013-dextropropoxyphen-130412.htm
In Hong Kong, the issue was discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board on 29 December 2010. After due risk assessment, the Committee concluded that the increased risks of serious abnormal heart rhythms caused by propoxyphene at therapeutic doses outweighed its benefits for pain relief. Therefore, a decision to deregister pharmaceutical products containing propoxyphene was made. Related news from TGA were posted on the website of Drug Office on 23 November 2011 and 20 February 2012.
Ends/ Saturday, April 13, 2013
Issued at HKT 12:00
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