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Update on TGA decision to cancel prescription pain-killers, 12 April 2013
Information and updates about the regulatory status of dextroropoxyphene-containing pain-killers
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.
The TGA reminds doctors and patients to carefully consider the warnings and contraindications contained in the Product Information and Consumer Medicine Information documents for Di-Gesic and Doloxene before prescribing or taking these medicines.
In its decision the AAT recognised the potential safety risks associated with dextropropoxyphene-containing products. The AAT had previously found that the difference between a therapeutic amount of products containing [dextropropoxyphene] and a potentially fatal dose was smaller than in many other therapeutic products and that the risk of accidental overdose, while it could be mitigated, could not be entirely overcome.' The AAT also found that, without a continuation of the significant safety warnings in the Product Information and Consumer Medicine Information for the medicines, including the 'black box' warnings, as well as periodic reminders to doctors and pharmacists about the risks associated with the use of the product, the safety and efficacy of Di-Gesic and Doloxene would be unacceptable. In accordance with the directions from the AAT, the TGA will now negotiate a process with the sponsor that will ensure that any conditions imposed by the AAT to mitigate the safety risks can be effectively monitored.
The TGA anticipates that the conditions will have the effect of placing significant responsibility on prescribers and pharmacists to ensure the new supply arrangements are met in order to protect public health.
In December 2011, the TGA issued a web statement publicising the decision to cancel all pain-killers containing dextropropoxyphene - Capadex, Di-Gesic, Doloxene and Paradex - from the ARTG, effective 1 March 2012.
The initial TGA decisions were confirmed in January 2012 after an internal review by the TGA. The sponsor of Di-Gesic and Doloxene then appealed to the AAT against the decisions to cancel these two products. There was no appeal in relation to Capadex and Paradex and both were cancelled from the ARTG on 1 March 2012.
On 17 February 2012 the TGA updated information for the public and health care professionals about the regulatory status of dextropropoxyphene-containing pain-killers after a preliminary decision by the AAT on 16 February 2012 to grant a stay on the implementation of the cancellation decisions for Di-Gesic and Doloxene.
The appeal was heard by the AAT over the course of a week in late May 2012.
On 20 June 2012, the AAT decided to refer the cancellation decisions for Di-Gesic and Doloxene back to the TGA for reconsideration, with a decision to be made by 15 August 2012. On 7 August 2012, by consent, the AAT extended the deadline to 12 September 2012.
On 12 September 2012 the decisions to cancel Di-Gesic and Doloxene from the ARTG were affirmed by the TGA after it found that the safety of those medicines was unacceptable.
A hearing was held by the AAT on 27 and 28 February 2013. The AAT handed down its decision on 5 April 2013, concluding that, subject to the imposition of appropriate conditions of the kind described in the decision, the quality, safety and efficacy of both Di-Gesic and Doloxene are not unacceptable. Consequently, the products will remain on the ARTG. Negotiations regarding the conditions 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.