Appeal overturns ban, adds conditions for Di-Gesic/Doloxene
A painkiller which has been banned in several countries will remain on the market in Australia, despite once being de-listed by the Therapeutic Goods Administration.
In 2011, the TGA took the painkillers sold under the brand names Di-Gesic and Doloxene off their list of approved medicines, deeming that “the safety of those medicines was unacceptable”. The company that makes the drug has fought back, winning an appeal which will allow them to be sold under some conditions.
The Therapeutic Goods Administration has indicated it will not try to appeal the Administrative Appeals Tribunal decision, even though some experts have claimed the compound is needlessly risky.
Under the new arrangements for Di-Gesic and Doloxene; doctors must sign a form when they are administered (especially to the elderly and with patients who may also be using tranquillisers, antidepressants or excess alcohol), they must be convinced that the patient is not at risk of accidental or intentional self-harm, and pharmacists have separate requirements as well.
Patients joined the fight to keep the painkiller on the market, saying it is the only thing the helps some conditions. Strong words have come from emergency room doctors though, who say the drug must be withdrawn.
Experts from the Australasian College of Emergency Medicine (ACEM) say; “emergency physicians are acutely aware of the toxicity of this agent”, and that there is insufficient evidence to accept that it can be used safely for the relief of pain.
“The medications have been associated with numerous deaths in the UK and has a high abuse potential,” said ACEM spokesperson Dr Sally McCarthy.