Di-Gesic (dextropropoxyphene 32.5mg and paracetamol 325mg) and Doloxene (dextropropoxyphene napsylate100mg) – update 15 March 2013

Di-Gesic and Doloxene continue to be registered on the Australian Register of Therapeutic Goods (ARTG) and doctors may continue to prescribe both products after carefully considering the indications, warnings and contraindications in the Product Information and Consumer Medicines Information for these products.

In February 2012, the Administrative Appeals Tribunal (AAT) granted a stay of the Therapeutic Goods Administration’s (TGA) decision to cancel the registrations of the products while Aspen’s appeal of the decisions was being heard.  In June 2012, the AAT delivered a judgment in which it found that the available evidence supported a conclusion that “there is likely to be a group of patients for whom there is unlikely to be an adequate analgesic alternative to DPP for mild to moderate pain”. The AAT’s decision was made after considering the evidence of scientific and medical experts put forward by both the TGA and Aspen.

The AAT referred the matter to the TGA for reconsideration, and while the TGA affirmed its decision to cancel the registrations of the products in September 2012, the decision to cancel is stayed until further order of the AAT. A further hearing before the AAT was held on 27 and 28 February 2013 and a decision is pending.

Aspen remains committed to ensure that patients are not left without adequate pain relief, and considers that this is likely to be the case if Di-Gesic and Doloxene are de-registered.

Di-Gesic is back in stock. Doloxene is on back-order.

Read the previous news release from September 2012.