Update on TGA decision to cancel prescription pain-killers, 12 September 2012

Related information

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

The TGA is providing updated information to the public and to health care professionals about the regulatory status of dextropropoxyphene-containing pain-killers following a reconsideration of its decision to cancel the registration of Di-Gesic and Doloxene.

Following the remitting of the matter from the Administrative Appeals Tribunal (AAT) for a reconsideration, the TGA affirmed the decisions to cancel Di-Gesic and Doloxene from the Australian Register of the Therapeutic Goods (ARTG) after finding that the safety of those medicines was unacceptable.

Proceedings regarding the cancellation of Di-gesic and Doloxene will now resume before the AAT. Because a stay of the decisions has been granted by the AAT, the cancellations 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.

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 an internal review by the TGA. The sponsor of Di-Gesic and Doloxene then appealed against the decision to cancel these two products to the AAT. 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 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.

Consistent with the intentions of the AAT in remitting the matter for reconsideration, the TGA considered various proposals put forward by the sponsor of the medicines that would allow the medicines to stay on the ARTG. The TGA was not satisfied that the proposals would address the safety issues identified.

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.

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