Di-Gesic and Doloxene prescription restrictions

Published in Medicinewise Living

Date published: About this date

Prescription pain relievers containing dextropropoxyphene — including the brands Di-Gesic and Doloxene — have been available for many years. But an emergence of safety concerns has prompted several countries to take these medicines off the market.

In December 2011, Australia's Therapeutic Goods Administration (TGA) cancelled all dextroproproxyphene-containing pain relievers after finding their safety and effectiveness was unacceptable. However, following an appeal against this decision by the company that markets Di-Gesic and Doloxene in Australia, these pain relievers will continue to be available — but under much stricter circumstances.

Find out more about pain relievers containing dextroproproxyphene and how the new prescribing and supply processes might affect you.

What are the safety issues with dextropropoxyphene?

It has been known for some time that dextropropoxyphene can easily build up in the body when pain relievers like Di-Gesic are used regularly. This can lead to serious side effects such as dizziness and confusion. 

Dextropropoxyphene can also be damaging to the heart. It has been found to increase the risk of abnormal heart beats (arrhythmias), which can be life-threatening.

Serious side effects or toxicity are more likely to happen if you take high doses of dextropropoxyphene, although problems can still occur when taking the recommended doses. Some people are also at greater risk, particularly older people and those who have reduced kidney function.

Can I take a pain reliever containing dextropropoxyphene?

New restrictions on the use of Di-Gesic and Doloxene mean they can only be prescribed if you have mild or moderate pain that can’t be adequately relieved by other medicines.

Before prescribing a pain reliever containing dextropropoxyphene, your doctor will need to know your age and any health problems you have, or have had in the past. This is because these pain relievers are not suitable for many people, including those who:

  • are older than 70
  • have kidney or liver disease
  • have ever had a heart attack or any other heart problem
  • have a history of alcoholism or substance abuse
  • have had depression or mental illness or have ever been suicidal.

Your doctor may recommend a kidney function test and monitor your heart to know whether or not you can take Di-Gesic or Doloxene.

It is also essential that your doctor, pharmacist and other health professionals know about all the medicines you are taking — including your prescription, non-prescription (over the counter) and complementary medicines, such as herbal remedies. Many medicines must not be used in conjunction with pain relievers containing dextropropoxyphene because of the risk of side effects.

Read the consumer medicine information (CMI) for Di-Gesic or Doloxene to find out more about what you need to do before you start, and while taking, these medicines. A CMI leaflet should be included in each medicine pack, or ask your doctor or pharmacist to print a copy. You can also download the CMI for your medicines

Should I stop or continue my pain reliever?

If you already take Di-Gesic or Doloxene, your doctor will need to review your treatment for pain. Your doctor can then advise whether you will need to stop or continue your medicine, or switch to a different pain reliever that doesn't contain dextropropoxyphene.

If you are stopping Di-Gesic or Doloxene you may experience withdrawal symptoms, such as nausea, feeling agitated or shaky, and you may develop a fever, excessive sweating or sleep problems. These can be prevented by reducing your dose slowly over time. However, let your doctor know about any withdrawal symptoms you experience while you are stopping the medicine.

What happens next?

From early 2014, a first-time prescription for Di-Gesic or Doloxene will require your doctor to sign and complete a Prescriber Confirmation form. This acknowledges that the medicine is the only suitable treatment for you, and that you understand the risks and how to take the medicine correctly. A pharmacist must see this form before they can supply you with Di-Gesic or Doloxene.

Your kidneys and heart will need to be checked regularly while you are taking Di-Gesic or Doloxene — ideally at least every 3 months. This is to help detect and prevent serious side effects.

The do's and don'ts of dextropropoxyphene

Do take your medicine exactly as directed by your doctor.

Do tell all your doctors, pharmacists, nurses and dentists that you are taking a pain reliever containing dextropropoxyphene.

Do tell your doctor or pharmacist about any side effects you may have. If you experience any of the following symptoms while taking dextropropoxyphene, stop the medicine and seek urgent medical assistance:

  • dizziness with shoulder pain
  • chest pain
  • light-headedness or fainting
  • irregular heart beats or palpitations
  • yellowing of the skin or eyes
  • seizures (fits)
  • abnormal thoughts or behaviours.

Don't take more than the recommended dose: even a small overdose can be dangerous.

Don't take with alcohol, antidepressants, antipsychotic medicines, sedatives or medicines for sleep problems.

Don't take if you:

  • have kidney, heart or liver problems
  • are older than 70
  • have a history of alcoholism or substance abuse
  • have had depression or mental illness, or been suicidal in the past.

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