TGA calls for action on cancelled analgesics
The TGA has issued an update on the regulatory status of four compounds after a preliminary decision by the Administrative Appeals Tribunal (AAT) to grant a stay on the implementation of the cancellation decision for Di-Gesic and Doloxene.
There is no appeal in relation to Capadex and Paradex, and the decision to cancel both these drugs from the Australian Register of Therapeutic Goods (ARTG) will come into effect on 1 March, the regulator said.
The TGA’s decision last month to cancel the four drugs from the ARTG was due to fears the safety risks of dextropropoxyphene outweighed the benefits of the painkillers and was in line with moves in the US, Europe and New Zealand.
The AAT appeal last week means that Di-Gesic and Doloxene will remain on the ARTG at least until the final hearing by the AAT has taken place, or until further order of the AAT.
The TGA cautions that its position over the safety of these drugs remains