Update on TGA decision to cancel prescription pain-killers, 19 September 2013
Information and updates about the regulatory status of dextroropoxyphene-containing pain-killers
The TGA is providing updated information to consumers and health professionals about the regulatory status of dextropropoxyphene-containing pain-killers.
On 12 September 2013, the Administrative Appeals Tribunal (AAT) handed down a decision imposing conditions on the registration of Di-Gesic and Doloxene that will allow them to remain on the Australian Register of Therapeutic Goods (ARTG). Those products are pain-killers that contain dextropropoxyphene.
At the end of 2011, the TGA cancelled all pain-killers containing dextropropoxyphene from the ARTG, effective from 1 March 2012, because it had found the safety of these medicines was unacceptable.
However, on 5 April 2013, following a number of hearings, the AAT concluded that, subject to the imposition of additional conditions and monitoring arrangements, the quality, safety and efficacy of Di-Gesic and Doloxene were not unacceptable.
The conditions imposed by the AAT require the sponsor to have arrangements in place designed to ensure that pharmacists do not dispense Di-Gesic or Doloxene without seeing a form signed by a doctor or dentist about the suitability of the product for that particular patient. The conditions require the sponsor to write to all doctors, dentists and pharmacies explaining these new arrangements.
Doctors and patients should carefully consider the warnings and contraindications contained in the Product Information (PI) and Consumer Medicine Information (CMI) documents for Di-Gesic and Doloxene before prescribing or taking these medicines.
The conditions imposed in the AAT’s decision of 12 September 2013 will require the sponsor to have arrangements in place designed to ensure that doctors and dentists sign a new form when prescribing Di-Gesic and Doloxene, confirming that they:
- are aware that the medicine is only approved for use in patients not able to be adequately treated with other mild analgesics
- have considered the contraindications for the medicine and have explained them to the patient at the time of prescribing
- have considered any recent changes to the patient’s clinical presentation or biochemical status
- have warned the patient at the time of prescribing about appropriate use of the medicine
- are satisfied at the time of prescribing that that the patient’s history does not indicate that the patient is at risk of accidental or intentional self-harm.
The conditions also require the sponsor to have arrangements in place designed to ensure that the signed form is presented to the pharmacist dispensing these medicines before supplying them to the patient.
The conditions provide for auditing of pharmacies to ensure that the new forms are being collected as required.
The operation of the AAT’s decision takes effect on 10 October 2013, which is 28 days after the decision. However, if either party lodges an appeal, the decision takes effect after any appeal is finally determined.
Once the AAT’s decision has taken effect, the sponsor has 14 days to lodge an application with the TGA to vary the PI for Di-Gesic and Doloxene. Following the TGA’s decision on that application, the other conditions described in the AAT’s decision must be implemented by the sponsor, including within 30 days sending letters to doctors, dentists and pharmacists explaining the new arrangements that apply to the supply of Di-Gesic and Doloxene.
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 consumers and health 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.
In its decision on 5 April 2013, 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 PI and CMI for the medicines (including the 'black box' warnings), as well as periodic reminders to health professionals about the risks associated with the use of the product, the safety and efficacy of Di-Gesic and Doloxene would be unacceptable.
However, the AAT found that, subject to the imposition of additional conditions and monitoring arrangements of a kind described in its decision, the quality, safety and efficacy would not be unacceptable for particular patients. For this reason, the products remained on the ARTG and negotiations on the conditions and monitoring arrangements were held between the sponsor and the TGA prior to being imposed by the AAT.
On 12 September 2013, the AAT handed down a decision imposing conditions on the registration of Di-Gesic and Doloxene that will allow them to remain on the ARTG. The conditions require the sponsor to have arrangements in place designed to ensure that pharmacists do not dispense Di-Gesic or Doloxene without seeing a form signed by a doctor or dentist about the suitability of the product for that particular patient. The conditions require the sponsor to write to all doctors, dentists and pharmacies explaining these new arrangements.
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, South Africa and India.