High risk painkillers dodge delisting

The manufacturers of two common prescription pain killers have won a reprieve against delisting, a week before the drugs were due to be withdrawn from the market due to serious safety risks.

Two of the four prescription pain relief medicines containing dextropropoxyphene, due to be cancelled from the Australian Register of Therapeutic Goods (ARTG) from 1 March 2012, have had a reprieve.

Late last year, the Therapeutic Goods Administration (TGA) decided to cancel four products known by the brand names Capadex, Di-Gesic, Doloxene and Paradex following an extensive review of information about the medicines’ safety and efficacy. The decision was to take effect from 1 March 2012.

However, the manufacturer of two of these brands of medicine – Di-Gesic and Doloxene – has appealed to the Administrative Appeals Tribunal (AAT). The AAT has decided that Di-Gesic and Doloxene should remain available for the time being — at least until the final AAT hearing has taken place, or until a further order of the AAT.

There is no appeal in relation to the other two brands – Capadex and Paradex – so these will no longer be available from 1 March, as planned.

The decision to cancel the four medicines came following an extensive review of the safety and efficacy of the dextropropoxyphene – a medicine in the opioid group – conducted by the TGA. The review found that only limited pain relief is provided by the dextropropoxyphene in Capadex, Di-Gesic, Doloxene and Paradex, and that there are serious safety risks with the use of these medicines.

According to the National Prescribing Service (NPS), the main risks associated with medicines containing dextropropoxyphene are to do with adverse effects on the electrical activity of the heart, including serious heart rhythm problems. These adverse effects on the heart can occur even at recommended doses. 

However people taking high doses of these medicines, such as the elderly and people with kidney problems, are particularly at risk.

In making its decision, the TGA determined that the overall risk of serious adverse reactions from these four medicines outweighs any benefits that may be provided. 

The NPS says evidence shows that the three medicines containing a combination of paracetamol and dextropropoxyphene (Capadex, Di-Gesic and Paradex) are no more effective than taking paracetamol alone.

CEO of the NPS, Dr Lynn Weekes, says that while Di-Gesic and Doloxene will remain on the market for the time being, the advice remains the same for all these medicines — that the potential harms outweigh the possible benefits.

“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, NPS agrees with the TGA’s decision to cancel the four pain relief medicines containing this active ingredient,” says Dr Weekes.

Dr Weekes says that anyone who had been taking any of the medicines containing dextropropoxyphene —Capadex, Di-Gesic, Doloxene or Paradex —should speak to their doctor about alternative pain relief medicines.

However, she warns against abruptly discontinuing these medicines.

“If you have been taking these medicines regularly for chronic pain, talk to your doctor about how to gradually change to a new medicine. Suddenly stopping these medicines is not recommended and can cause a range of unpleasant withdrawal symptoms,” says Dr Weekes.

This TGA position is consistent with medicine regulators in the United States, Europe, New Zealand and elsewhere, where dextropropoxyphene-containing medicines have been removed from the market.

Tags: capadex, dextropropoxyphene, di-gesic, doloxene, lynn-weekes, medicines, national-prescribing-service, paradex, therapeutic-goods-administration,

17 thoughts on “High risk painkillers dodge delisting

  1. Capadex and Paradex will no longer be available from 1 March – due to safety concerns. The AAT has decided that Di-Gesic and Doloxene (scheduled to be removed for the same reasons) should remain available for the time being ?????????????

  2. To totally ban this drug is absolutely unfair to people such as myself who are either unable to use anything else or who have found nothing else works. I have taken digesic for migraine for 25 odd years – my heart is fine (yes I have had an ECG) and I have no other ill effects from this drug. In all these years nothing else has killed the pain of migraine – digesic has stopped the pain completely. It changed my life. I no longer had the fear and anxiety of migraine. Take this drug away and I am back to square one – not fair!

  3. I have been taking digesic for over 13 years for the terrible pain of endometriosis and migraine. I have an ulcer so I cant take NSAIDS and I cannot tolerate opiates such as codeine or morphine. The people who say it’s no better than paracetamol alone are obviously not using it!

  4. I have been taking Digesic for twelve years – firstly for the pain associated with breast cancer
    and then for an extremely bad back. I have not had any problems with this medication.
    I certainly cannot take just paracetomal – it is not strong enough.

  5. I take doloxene for joint bleed pain. For haemophilia pain Paracetomol is utterly useless. Doloxene never did me harm.

  6. I was taking Capadex until they took it of the market, I had no side effects whatsoever and I don’t drink alcohol (the real reason why it was taken off). Normal paracetamol does nothing to chronic pain, and to say that capadex is no stronger is total bullshit. I now suffer from a chronic back pain, pelvic pain (broken in 4 places in accident), shoulder pain…..basically my life is full of pain, I wake up with it, I go to sleep with it……Capadex worked, it took away 80-90% of the pain.
    I now take tramidol, endone, & neurofen plus just to get some form of relief , I have also had 8 spinal injections.
    So instead of taking Capadex 2x twice a day, I now take a cocktail of other tablets (not at once) to make life slightly bearable and have had some bad side effects like nausea.
    Thank you

  7. Have you tried Digesic Michael. Maybe that would work as I think it is the same as Capadex? (and is still on the market but under stricter access)

  8. Since having a craniotomy for a brain tumour 10 years ago I have been taking Capadex for headaches. I hardly take any now but was taking them regularly for the first couple of years. Now when I have a headache I can take 1 Capadex that hits the pain almost immediately and I can literally feel the pain lifting. I still have a supply and will continue to take them as needed. Whoever says that paracetamol on its own works just as well has never suffered serious pain. I wonder how many paracetamol one needs to take to get the same relief? And what will that do for our kidneys? Remember “take a BEX and have a good lie down”. That caused a lot of problems with kidney failure.

  9. I too was taking Capadex up until a couple of years ago for back pain and arthritis and never had a problem with it , it was the only thing that gave me pain releif until it was suddenly not available and i now take Ms contin which does not give me anywhere the releif that i need with out getting addicted if i try to take extra for pain releif, As i have been reading everyones stories on pain i too agree that capadex worked well for me and anyone with serious pain, paracetamol does nothing. Since i have been off capadex i have a tuff time managing my pain and people that say differant , dont know what pain is.

  10. I have been taking DI-Gesic for over 35 years on and off ( spinal surgery , stenosis, + curvature of the spine ) I only take it when absolutely need it , I have had no side effects and swear by it as the only thing I can tolerate for pain relief . it is the difference between going on a day out in less pain and being miserable in acute pain . Now its a big mess up trying to get it, the Dr has to get a Procedure Confirmation Form before the chemist can dispense it and a new one obtained for each script !!! would be easier to get hold of some POT for pain relief

  11. They should be taking Tramadol off the market. It has heaps of side effects. It causes confusion in the aged, also. Even with this, doctors continue to prescribe this drug for the aged patient.

  12. I have been on tramadol for over 5 years. For a combination of spinal nerve pain, arthritis and migraine. I know it can be dangerous. But my doctor won’t prescribe anything stronger than tramadol. If it’s withdrawn from the market in Australia, what alternatives can I try?

  13. Banning these high doses is classic move as sometimes they prove to catastrophic in human lives. Rather paracetamols and some analgesic can serve their purpose instead of these dangerous drugs.

  14. Yes I too agree with the above people. Paracetamol alone is absolutely useless for severe pain. If taken as directed by your physician di-gesic is the drug of choice for chronic severe pain. I used di-gesic for approximately 12 years under the care of my rheumatologist without any side effects.

  15. I have had good results with Capadex also, again prescribed by rheumatologist for stress fractures I inflict on myself on a daily basis doing everyday stuff. I have Ehlers Danlos Syndrome Hypermobility type. It is in same group of disorders as osteogenesis imperfecta. Only we don’t get outright fractures like they do.

    I found it difficult to get a GP to represcribe it 34 years ago. I had to go back to the rheumatologist all the time. Resorted to using OTC panadol, and codeine. Then a chemist suggested 15 mg codeine not 12.5 and this made quite a difference in the reduction of pain. Tramadol has also worked, but impossible to get.

    God I hope all these experts who pontificate that codeine doesn’t help any more than paracetamol alone get a severe chronic pain condition and try something like Osteoeze ie very high dose paracetamol for pain relief. Utterly useless. Now due to wear and tear of EDS I also have osteoarthritis in small and large joints like hands and hips. Given endone and a cane and a diagnosis of OA at the hospital after I woke up in excruciating pain the day after I tried to add side leg raises to my physiotherapy. That is I injured myself severely doing physiotherapy that is supposed to help me!

    Part of EDS is GERD, hiatus hernia and stomach ulcers, and GI issues. Ibuprofen should be wonderful for that, NOT.

    I’d like to see the studies that were done. Did they cover ALL painful conditions?? Bet you they did not but yet they extrapolate these conclusions to everyone. Were they actually tested on real human beings and not just mice? I’m sure I could demolish the studies with one hand tied behind me.

    Maybe I should just become an alcoholic -not likely as alcohol gives me migraines, or claim to be so I can just rock up to the counter with a prescription for Subitrex – morphine used almost exclusively for alcoholism. I would not be given any grief. But someone without an addiction, well you can’t get ANY useful pain meds. Whoopy do!

  16. My two cents worth. Having severe dental/sinus disease and pain from age 10 til 29 when i had to have the last of my teeth surgically removed after a catastrophic infection that nearly killed me combined with a paracetamol overdose from being denied adequate pain relief while out of my mind with the pain, i can say with complete certainty that the people saying these products are no more effective than panadol have never experienced the kind of pain i lived with.
    i could take any other medication and would be still writhing on the floor screaming for my mother or doped to the gills but still aware of and exhausted by the pain. capadex at the standard doses was the only medication that worked reliably for this particular pain. it saved me many times over and i was not exposed to the risk of addiction found in opiates as it gave me no high at all. just did its job. reading the personal testimonies above as well as knowing first hand the efficacy of this medication to be above all others with my type of pain id like to know who the hell these researchers are using in their trials and what sort of pain are they trying to treat?? just madness.

  17. @MAZINOZ I do understand you are angry and frustrated but your statements about the research is utter bull.

    I am a chronic pain patient am also a former health care clinician and researcher.

    If you are questioning the science behind Capadex being taken off the market instead of making rhetorical statements why don’t you perform a literature search on Pubmed etc. Additionally all medications that are TGA approved and added to the PBS must be rigorously trialed on humans.

    To everyone who has made negative comments about paracetamol it may not be effective in severe pain. Paracetamol works synergistically with opioids which improves the pain relieving effects of the opioids. So the total sum of both is greater than the individual drugs alone.

    Tramadol is a pro drug that can overwork the liver and does have some incredibly serious side-effects. Side effects such as a s erotonin syndrome. A far safer alternative to Tramadol is Tapentadol. The efficacy in chronic pain management is supported by the literature.

    In my 30 years in healthcare what has become apparent is the prescribing of opioids that were only used in palliative care.

    Pain is very subjective and most people would do almost anything to fund a solution. The research does indicate a not to uncommon situation where patients are cut off their opioids by their prescriber as a result people out of desperation turn to illicit drugs such as heroin or opioid tablets that have been diverted to the black market. It doesn’t take a rocket scientist to work out how disastrous that situation could be.

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