Dextropropoxyphene to be Withdrawn on 1 August 2010

Medsafe has announced that all dextropropoxyphene-containing medicines will be withdrawn from the New Zealand market on 1 August 2010.  This is after a review of their safety and efficacy has shown that their risks outweighed their possible benefits.

The consents to distribute Paradex and Capadex will be revoked on 1 August 2010.  Consents to distribute Digesic and Doloxene have previously lapsed.

This means that from 1 August you will not be permitted to dispense Paradex or Capadex.

The only exception will be when a medical practitioner initiates the supply of an unapproved medicine through sections 25 or 29 of the Medicines Act.

This prohibition includes repeats that may be valid on 1 August - you cannot dispense them.  Nor can you use stock-on-hand to dispense under sections 25 or 29 – that stock has to be specifically imported for that specific patient.  Nor can you advertise the availability of Paradex or Capadex from your pharmacy.  The Pharmac subsidy will also be withdrawn on 1 August.

 This announcement follows notification last month of the decision by Medsafe to withdraw in the near future the consent to distribute dextropropoxyphene.  The date of withdrawal has now been set.  Prescribers have been asked to not start any new patients on Paradex or Capadex, and to review at the earliest opportunity the analgesic requirements of those patients currently prescribed them. 

Click here for the letter sent by Medsafe to pharmacists, dated 12 July 2010.

Click here for the letter sent by Medsafe to healthcare professionals, dated 26 March 2010.

The advice from BPAC for transferring patients from dextropropoxyphene-containing medicines is that most should be able to be transferred to full doses of paracetamol alone.  If pain relief is not sufficient, the next step is to add a weak opioid such as codeine (or use a combined paracetamol/codeine preparation).  Alternatively, tramadol could be triailed. 

As dextropropoxyphene is a weak opiate it is possible that some patients may experience a withdrawal reaction upon discontinuation of treatment.  Should a patient experience a severe withdrawal reaction advice may be sought from a local alcohol and drug dependence service.

The Medicines Adverse Reactions Committee (MARC) has reviewed the benefits and risks of dextropropoxyphene-containing medicines by assessing the published literature, adverse reactions reported in NZ and internationally, NZ Poisons Centre data and the results of a Paradex utilization study conducted in NZ in 2007.  MARC concluded there is evidence that:

*  These medicines are no more effective than maximum recommended doses of paracetamol alone.

*  These medicines have the potential to cause more adverse reactions than paracetamol used at recommended doses.

*  These medicines are more dangerous than other simple analgesics in overdose, particularly when combined with alcohol.

*  Deaths related to dextropropoxyphene overdose have occurred within 1 hour of ingestion and before medical intervention could be obtained.

*  Prescribing restrictions introduced in 2006 have failed to ensure that these medicines were only used in patients for whom the benefits are likely to outweigh the risks.

*  Overall the risks of these medicines exceed their benefits.

Click here for the Medsafe letter to health professionals, dated 9 Feb 2010

Click here for media statement to be released to the public at midday 9 Feb 2010

Click here for the Medsafe review of the benefits and risks of dextropropoxyphene-containing medicines.  NOTE LARGE SIZE FILE 2.5MB

Click here for the December 2009 Minutes of the MARC meeting that discussed the dextropropoxyphene issue

Click here for a questions and answers document about the withdrawal

Click here for the 4 September 2009 notification published on the PSNZ website concerning the review being undertaken by Medsafe on the safety and efficacy of all medicines containing dextropropoxyphene.

Euan Galloway

Chief Pharmacist Advisor

Pharmaceutical Society of NZ