NPS supports TGA decision to cancel four pain relief medicines

24 November 2011

NPS has applauded the TGA’s decision to cancel four prescription pain relief medicines containing dextropropoxyphene from 1 March 2012.

The TGA has decided to cancel the products known by the brand names Capadex, Di-Gesic, Doloxene and Paradex following an extensive review of information about the medicines’ safety and efficacy.

NPS CEO Dr Lynn Weekes says that the decision to cancel the medicines was a logical step given the available evidence, and their withdrawal from sale in many other countries.

The TGA decided to cancel these medicines as the active ingredient, dextropropoxyphene, has been shown in many studies to affect the electrical activity of the heart, increasing the risk of serious arrhythmias (disturbances in the normal rhythm of the heart-beat). The TGA review of its efficacy also found that only limited pain relief is provided by these medicines.

“It is important that decisions about medicines regulation are always made in the context of the evidence,” says Dr Weekes.

All medicines have both benefits and risks. In a previous review of the evidence NPS concluded that taking medicines containing a combination of paracetamol and dextropropoxyphene (including Capadex, Di-Gesic and Paradex) is no more effective than taking paracetamol alone.

Fixed-dose combinations such as is found in these medicines are also generally taken at a frequency that increases the risk of adverse effects from accumulation of the active ingredient dextropropoxyphene and its cardiotoxic metabolite.

“Given the limited benefit of pain relievers containing dextropropoxyphene, the risks associated with their use, and the fact that we also know dextropropoxyphene can cause dependency, on balance we agree with the TGA’s decision to cancel these four pain relief medications containing this active ingredient,” says Dr Weekes.

“However, it is very important that anyone who had been taking Capadex, Di-Gesic, Doloxene or Paradex regularly for chronic pain or from time to time for short term pain relief speaks to their doctor about alternative pain relief medicines, and does not stop taking their medicine as prescribed until they have spoken to their doctor as suddenly stopping a medicine can cause a range of withdrawal symptoms.

“Your doctor is best placed to work with you to establish what medicines you need to take.”

Top 5 medicinewise questions for people managing pain

It’s important you speak to your doctor about what is right for you. Our top 5 questions to ask include:

  • What pain reliever medicine is best for my condition?
  • Does my condition affect which pain relievers I can take safely?
  • What is the active ingredient in this pain reliever?
  • What do I need to tell my health professionals before taking this medicine?
  • How regularly should my medicines and pain management plan be reviewed?

NPS has resources for people who take pain relief medicines

Visit our website, www.nps.org.au, to learn more about being medicinewise when managing your pain. Our website has information about knowing which medicine to take safely if you have a chronic condition. NPS also offers a Medicines List which helps you keep track of your medicines.

If you have questions about your medicines, you should talk to your doctor, or you can phone our Medicines Line on 1300 MEDICINE (1300 633 424).


ENDS

Independent, evidence-based and not-for-profit, NPS enables better decisions about medicines and medical tests.We are funded by the Australian Government Department of Health and Ageing.