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Safety Information

Revised: 26 June 2013

Withdrawal of Dextropropoxyphene-containing Medicines

3 December 2009

Dear Healthcare Professional

In December 2009 the Medicines Adverse Reactions Committee (MARC) reviewed the benefits and risk of dextropropoxyphene-containing medicines1 . The MARC assessed the published literature; adverse reactions reported in New Zealand (NZ) and internationally; NZ Poisons Centre data, the results of a Paradex utilisation study conducted in New Zealand in 2007. The MARC also considered reviews conducted by other medicine regulators.

After analysis and discussion of the available data the MARC concluded there is evidence that2 :

Therefore, in the interests of public safety, the MARC has recommended that Capadex and Paradex be withdrawn from New Zealand 4.

Medsafe supports the MARC's conclusions and is currently implementing their recommendation. In recognition of the significant number of patients currently taking dextropropoxyphene-containing medicines, the withdrawal will not be immediate to allow sufficient time for patients to be transferred to alternative medications.

In the interim, Medsafe advises the following:

Further information will be provided as it becomes available. It is likely that a final date for withdrawal will be known within the next month.

Yours sincerely

Marius Rademaker
Acting Chair
Medicines Adverse Reactions Committee

Stewart Jessamine
Group Manager
Medsafe

 

  1. Capadex and Paradex are the only dextropropoxyphene-containing medicines available in New Zealand.
  2. A summary of the MARC's discussion on dextropropoxyphene is included in the minutes of the December 2009 meeting
  3. Reith D et al. 2005. Opioid poisoning deaths in New Zealand (2001-2002). NZMJ 118(1209): U1293.
  4. Dextropropoxyphene containing medicines have already been withdrawn from the UK and Sweden. Medicines regulators in Europe and Singapore have also announced that they will be withdrawing these medicines.

Additional information

 

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