TGA to cancel four prescription pain-killers from 1 March 2012

The TGA intends to cancel all pain-killers containing dextropropoxyphene - Capadex, Di-Gesic, Doloxene and Paradex - from the Australian Register of Therapeutic Goods (ARTG), from 1 March 2012.

Following a review of the available evidence, the TGA found that the safety risks of using pain-killers (analgesics) containing dextropropoxyphene outweighed the benefits.

Cancellation from the ARTG means that these prescription medicines can no longer be supplied by their Australian sponsors, Aspen Pharma Pty Ltd and Aspen Pharmacare Australia Pty Ltd. Capadex, Di-Gesic, Doloxene and Paradex will become unavailable for use.

Alternative pain-relieving medicines are available. People using Capadex, Di-Gesic, Doloxene or Paradex should plan with their doctor to move to alternative pain relief well before 1 March 2012.

The cancellation date has been set so that patients can move safely to alternative treatments - there is a risk that patients who have been taking these medicines for some time may experience withdrawal symptoms by stopping suddenly.

Under the Therapeutic Goods Act 1989 the sponsor can request a review by a delegate of the Minister of a decision to cancel the registration of a product. On 24 November 2011 the TGA received from the Australian sponsors of the products requests for a review of the decisions to cancel the registration of the products. A decision on each request has to be made within 60 days.

Why the TGA is taking this action

Dextropropoxyphene has recently been shown to affect the electrical activity of the heart, increasing the risk of serious arrhythmias (disturbances in the normal rhythm of the heart-beat). This effect is more pronounced with high doses or overdoses.

An extensive review of the safety and efficacy of dextropropoxyphene has been conducted by the TGA. The review found that only limited pain relief is provided by the dextropropoxyphene in Capadex, Di-Gesic, Doloxene and Paradex, and that there are serious safety risks with the use of these medicines.

The TGA has determined that the overall risk of serious adverse reactions outweighs any benefits that may be provided by these medicines. This position is consistent with medicine regulators in the United States, Europe, New Zealand and elsewhere, where dextropropoxyphene-containing medicines have been removed from the market.

Information for patients

Regular users

If you have been taking Capadex, Di-Gesic, Doloxene or Paradex regularly for chronic pain, you should not stop taking the medicine until you have talked with your doctor. Suddenly stopping the medicine may cause you to experience withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety and shivering.

Patients with short term pain

If you have taken Capadex, Di-Gesic, Doloxene or Paradex from time to time for short term pain relief, you should now use an alternative pain medicine. Your doctor can provide advice and help you change to a different method of relieving your pain.

Information for health professionals

You are encouraged to plan with your patients the change to an appropriate alternative method of pain relief at the earliest opportunity. Any transition plans for patients should be in place before 1 March 2012, the intended date that Di-Gesic, Capadex, Paradex and Doloxene will no longer be supplied in Australia.