The Administrative Appeals Tribunal surprised many medical professionals by recommending the continued registration of dextropropoxyphene. Their reasons are interesting, starting from the observation that a medicine may lose registration if “it appears to the Secretary (of the Department of Health and Ageing) that the quality, safety or efficacy of the goods is unacceptable”.

With no challenge to the quality, it remained for the Therapeutic Goods Administration (TGA) to prove the safety and efficacy to be unacceptable.

The tribunal found that Di-Gesic® and Doloxene® are effective, although not exceptionally so, and that their safety profile at therapeutic doses is similar to other weak opioids. The narrow therapeutic window means that there is an ongoing risk of toxicity or death from accidental, or intentional, overdose. They agreed with the TGA that suicide is not a valid reason to withdraw access to any drug from eligible patients, particularly as there are so many other drugs that a determined person could choose.

Dextropropoxyphene was found to be the only available option for patients who are unable to metabolise either codeine or tramadol. These patients, estimated at between 0.1% and 1% of the population, became pivotal as the withdrawal of registration would not support the preferred position that “if the interests of the few can be reconciled with the interests of the many, then they should be, rather than overridden.”

Aspen and the TGA will now negotiate stringent controls on pharmacists and prescribers to confine supply to medically stable and fully informed patients that can’t use other analgesics, and that are not at risk of overdose (accidental or intentional).

References:

  1. Administrative Appeals Tribunal of Australia. Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing, 2013. AATA 197.