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Update on TGA decision to cancel prescription pain-killers, 13 March 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.
The decisions to cancel Di-Gesic and Doloxene from the Australian Register of Therapeutic Goods (ARTG) were affirmed by the TGA on 12 September 2012 after it found the safety of those medicines was unacceptable.
Proceedings have resumed before the Administrative Appeals Tribunal (AAT) in which the sponsor of the medicines is seeking to overturn the cancellation decisions. A hearing was held by the AAT on 27 and 28 February 2013 and the AAT is now considering its decision. Because of the stay granted by the AAT, the cancellation decisions will not take effect until further order of the AAT.
In the interim the TGA urges doctors and patients to carefully consider the warnings and contraindications contained in the Product Information and Consumer Medicines Information documents for Di-Gesic and Doloxene before prescribing or taking these medicines.
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 against the decisions to cancel these two products to the AAT. 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 and a decision by the AAT in the proceedings is expected in the near future. Because of the stay granted by the AAT, the cancellation decisions will not take effect until further order of the AAT. The website will be updated when the outcome is known.
There are mechanisms under the Therapeutic Goods Act 1989 by which those patients currently taking Di-Gesic or Doloxene can continue to access this medicine should the cancellation decisions be implemented.