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Update on TGA decision to cancel four prescription pain-killers, 17 February 2012
Information and updates about the regulatory status of dextroropoxyphene-containing pain-killers
The TGA is updating the public and health care professionals about the regulatory status of dextropropoxyphene-containing pain-killers after a preliminary decision by the Administrative Appeals Tribunal (AAT).
The TGA's position regarding the poor safety and efficacy profile of these medicines has not changed as a result of this preliminary AAT decision.
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), to come into effect on 1 March 2012.
This decision was made after the TGA found that the safety risks of using pain-killers (analgesics) containing dextropropoxyphene outweighed the benefits that may be provided by these medicines. This position is consistent with that of medicine regulators in the United States, Europe, New Zealand and elsewhere, where dextropropoxyphene-containing medicines have already been removed from the market.
The initial TGA decision to cancel the registration of the four medicines was confirmed in January 2012 after review by a delegate of the Minister. The sponsor of Di-Gesic and Doloxene has now appealed to the AAT against the decision to cancel these two medicines. The hearing of the appeal is currently scheduled to start towards the end of May 2012.
On 16 February 2012, the AAT granted a stay on the implementation of the cancellation decision for Di-Gesic and Doloxene. The cancellation decision on these two medicines will not therefore become operative on 1 March 2012. Di-Gesic and Doloxene will now remain on the ARTG at least until the final hearing by the AAT has taken place, or until further order of the AAT.
The decision by the AAT to grant the stay did not involve a finding against the TGA decision that the safety risks of using the medicines outweighed the benefits. In fact the AAT found that "there is a significant case relating to the safety, and even the efficacy, of the products". There is no appeal in relation to Capadex and Paradex. The decision to cancel both Capadex and Paradex from the ARTG will therefore become effective on 1 March 2012.
Product Information changes
As a condition of the granting of the stay the AAT is requiring the sponsor to request the TGA's agreement to changes to Product Information (PI) documents for Di-Gesic and Doloxene. While the wording of these changes has not been finalised the revised PI documents will include:
- A warning regarding the possibility that Di-Gesic and Doloxene may cease to be available a short time after the final AAT hearing if the appeal is rejected.
- A strong warning that for management of chronic pain, regular users of Di-Gesic or Doloxene who have not recently trialed alternative analgesia should attempt to replace these products with alternative analgesia.
- A strong warning that patients not currently using dextropropoxyphene-containing products should not be started on them.
- A strong warning regarding the substantial QT prolongation now known to be caused by dextropropoxyphene at recommended doses. This warning also highlights some key contraindications to use and a new recommendation for baseline and ongoing monitoring of renal and cardiac function.
- The narrowing of the indication for use to "relief of mild to moderate pain in patients who do not respond adequately to other analgesics".
- Information about the Multiple Ascending Dose study of dextropropoxyphene that established the existence of substantial, dose-dependent QT prolongation.
Similar changes to the Consumer Medicines Information (CMI) documents for Di-Gesic and Doloxene are required and the CMI will be an insert in each pack.
The TGA considers that these changes to PI and CMI documents for Di-Gesic and Doloxene are necessary while the two products remain on the ARTG. However, the TGA remains of the view that these (or similar) changes are not sufficient to mitigate the safety risks associated with these products. So while it is necessary to ensure the PI and CMI are updated to reflect current knowledge about Di-Gesic and Doloxene, the TGA will be strongly arguing to the AAT that the decision to cancel these products from the ARTG should be upheld.
The sponsor is also required to write to pharmacists and certain doctors concerning these matters.
The TGA's previous recommendations regarding the transition of patients away from Di Gesic and Doloxene have not changed (although these products will remain available on the market for longer than initially proposed by the TGA).
The TGA recommends that people using Capadex, Di-Gesic, Doloxene or Paradex should plan with their doctor to move to alternative pain relief.
Capadex and Paradex will no longer be available from 1 March 2012. Di-Gesic and Doloxene will remain on the ARTG (and thus, available as prescription-only medicines) at least until the AAT hearing currently scheduled to start towards the end of May 2012. In this regard it is important to note the following:
- If the AAT rejects the sponsor's appeal against cancellation, both Di-Gesic and Doloxene may be removed from the ARTG at short notice.
- There is a risk that patients who have been taking these medicines for some time may experience withdrawal symptoms by stopping suddenly.
The TGA recommends that patients who have already transitioned to alternative pain-killers not recommence Di-Gesic or Doloxene.
If you have been taking Capadex, Di-Gesic, Doloxene or Paradex regularly for chronic pain, you should not stop taking the medicine until you have talked with your doctor. Suddenly stopping the medicine may cause you to experience withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety and shivering.
If you are currently taking Capadex or Paradex, please note that there is only a short time left before these products become unavailable for supply, so it is advisable to contact your doctor soon to discuss the transition to alternative pain relief.
Patients with short term pain
If you have taken Capadex, Di-Gesic, Doloxene or Paradex from time to time for short term pain relief, you should now use an alternative pain medicine. Your doctor can provide advice and help you change to a different method of relieving your pain.
You are encouraged to plan with your patients the change to an appropriate alternative method of pain relief at the earliest opportunity:
- Any transition plans should be in place before 1 March 2012 for patients currently on Capadex or Paradex.
- For patients on Di-Gesic and Doloxene, the TGA encourages planning for transition to alternative methods of pain relief at the earliest opportunity. These products may be cancelled from the ARTG (and thus become unavailable) at short notice after the AAT hearing at the end of May 2012, depending on the outcome of that hearing.