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Controversial painkillers stay on the shelves

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A painkiller that has been banned in dozens of countries because of safety fears can still be prescribed in Australia, following a decision of the Administrative Appeals Tribunal.

In the end to a long-running case, the Tribunal ruled last month that painkillers containing dextropropoxyphene – which has been associated with fatal overdoses and heart arrhythmia – may not be dispensed unless the prescribing doctor signs a form attesting to the suitability of the drug for that particular patient.

The ruling brings to an end a case that began almost two years ago when the Therapeutic Goods Administration (TGA) banned from sale all painkillers containing dextropropoxyphene, including Capadex, D-Gesic, Doloxene and Paradex, following its withdrawal from the marketplace in the United States, Britain, New Zealand, Canada, Sweden and across the European Union.

In February 2012 the manufacturers of Di-Gesic and Doloxene successfully sought a stay on the ban in the Administrative Appeals Tribunal (AAT), which ordered the TGA to review its decision.

The decision to ban the drugs was reaffirmed by the TGA last September, ruling that the safety risk posed by the drugs was unacceptable.

But the manufacturers disputed the ruling before the AAT and in April this year the Tribunal ruled that the painkillers could remain on the Australian Register of Therapeutic Goods subject to conditions.

The Tribunal made its decision despite acknowledging the safety risks posed by the drug, including 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”.

Last month the AAT set the conditions under which Di-Gesic and Doloxene can continue to be sold in Australia, including specific requirements for doctors.

When prescribing Di-Gesic and Doloxene, medical practitioners will be required to sign a form confirming that they:

  • are aware that the medicine is only approved for use where mild analgesics are not considered adequate;
  • have considered the contraindications for the medicines 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 the appropriate use of the medicine; and
  • are satisfied at the time of prescribing that the patient’s history does not indicate that they are at risk of accidental or intentional self-harm.

The distributors have been directed to ensure that pharmacists do not dispense either medication without first seeing such a form signed by the prescribing doctor or dentists attesting to the suitability of the drug for their particular patient. Furthermore, the distributors must write to all doctors, dentists and pharmacies explaining the new arrangements.

Reflecting continued anxiety about the safety of the drug, the TGA has urged doctors and dentists to “carefully consider” the warnings and contraindications regarding Di-Gesic and Doloxene before prescribing them.

Adrian Rollins