PGA Newsletter – Vol.2 No.6 22nd Feb.,2012

22nd Feb,2012

The Therapeutic Goods Administration (TGA) has updated the public and health care professionals about the regulatory status of dextropropoxyphene-containing painkillers after a preliminary decision by the Administrative Appeals Tribunal (AAT).

The TGA’s position regarding the poor safety and efficacy profile of these medicines has not changed as a result of this preliminary AAT decision.

However, the removal from the market of Di-Gesic from 1 March 2012 has been postponed because of a continuing AAT appeal.

In December 2011, the TGA issued a web statement publicising the decision to cancel all painkillers containing dextropropoxyphene, including Capadex, Di-Gesic, Doloxene and Paradex, from the Australian Register of Therapeutic Goods (ARTG).

This decision was made after the TGA found that the safety

risks of using painkillers containing dextropropoxyphene outweighed the benefits that may be provided by these medicines. This position is consistent with that of medicine regulators in the United States, Europe, New Zealand and elsewhere, where dextropropoxyphene-containing medicines have already been removed from the market.

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PGA Newsletter – Vol.2 No.6 22nd Feb.,2012