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Update on TGA decision to cancel prescription pain-killers, 6 September 2012

Related information

  • Dextropropoxyphene
    Information and updates about the regulatory status of dextroropoxyphene-containing pain-killers
6 September 2012

The TGA is updating the public and health care professionals about the regulatory status of dextropropoxyphene-containing pain-killers after a decision by the Administrative Appeals Tribunal (AAT) that the TGA reconsider its decision to cancel Di-Gesic and Doloxene.

Status of dextropropoxyphene-containing 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 Australian Register of Therapeutic Goods (ARTG), effective 1 March 2012.

The initial TGA decision was confirmed in January 2012 after review by a delegate of the Minister. The sponsor of Di-Gesic and Doloxene then appealed to the AAT against the decision to cancel these two products. There was no appeal in relation to Capadex and Paradex and both Capadex and Paradex 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 decision 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 decision for Di-Gesic and Doloxene 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. The TGA's reconsideration decision is now expected by 12 September 2012.

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.