Revised: 26 March 2010

Publications

Paradex and Capadex will be withdrawn from New Zealand market on 1 August 2010

On 1 August 2010 the consents to distribute medicines containing dextropropoxyphene (Capadex and Paradex) in New Zealand will be revoked.

Last month Medsafe announced that following a statutory review of the safety and efficacy of these medicines found that the risks of their use outweighed any possible benefit. In order to protect the health of New Zealanders these medicines would be withdrawn.

Medsafe Group Manager Dr Stewart Jessamine said it was recognised that time was needed to manage the care of patients. After consultation with clinicians from the Royal New Zealand College of General Practitioners, it has been decided that consent to distribute these medicines will be revoked on 1 August 2010. It was felt that this date should allow doctors sufficient time to transfer their patients safely onto alternative treatments.

The action in New Zealand follows the withdrawal of medicines containing dextropropoxyphene in the European Union and in Singapore.

Medsafe advises that patients currently taking Capadex or Paradex should discuss their ongoing treatment with their doctor.

As with all medicines, consumers and healthcare professionals are encouraged to report all suspected adverse reactions to the Centre for Adverse Reactions Monitoring.

ENDS

Additional information

• Dextropropoxyphene is a pain killer, belonging to the opioid class of medicines.
• Medicines containing dextropropoxyphene are painkillers used to treat chronic moderate pain. Two medicines containing dextropropoxyphene are currently available in New Zealand - Paradex tablets and Capadex capsules.
• On 9 February 2010 Medsafe announced that all medicines containing dextropropoxyphene are to be withdrawn from the New Zealand market after a review of the safety and efficacy of these medicines showed that their risks outweighed their possible benefits. See www.medsafe.govt.nz/hot/media/2010/ParadexandCapadex.asp
• More information is available as a Question and Answer document www.medsafe.govt.nz/hot/media/2010/QandACapadexandParadex.asp
• The Medicines Adverse Reactions Committee (MARC) is an independent expert advisory committee that advises the Minister of Health on medicines safety issues. A summary of the Committee's discussion on dextropropoxyphene is included in the minutes of the December 2009 meeting, available on the Medsafe website: www.medsafe.govt.nz/profs/adverse/Minutes140.htm
• After reviewing the available evidence the MARC concluded that these medicines:
  • were no better at treating pain than taking full dose paracetamol
  • could cause additional side effects to those caused by paracetamol used at recommended doses
  • were dangerous in overdose, or if they were taken with alcohol.
• In 2009, 78,000 patients were estimated to be taking dextropropoxyphene-containing medicines in New Zealand.
• The MARC first reviewed the use of Capadex and Paradex in 2005. More information is available in the Question and Answer document: www.medsafe.govt.nz/hot/media/2010/QandACapadexandParadex.asp
• Medsafe is the New Zealand Medicines and Medical Devices Safety Authority, and is part of the Ministry of Health.
• In the United Kingdom where dextropropoxyphene has been withdrawn the majority of patients were effectively changed to other pain relievers including paracetamol alone, codeine alone, or a codeine/paracetamol combination product.

For media queries, please contact: Karalyn van Deursen, Senior Media Advisor (04 496 2115, 021 832 459)