Published: February 2010

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Dextropropoxyphene - review concludes risk-benefit balance unfavourable

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Prescriber Update 31(1): 1
February 2010

In December 2009 the Medicines Adverse Reactions Committee (MARC) reviewed the benefits and risks of dextropropoxyphene-containing medicines referred under section 36 of the Medicines Act 1981. This review was triggered by the results of a study evaluating the prescribing of these medicines in New Zealand. The study found that less than half of the prescriptions dispensed were in line with the approved indication, which had previously been restricted in 2006¹.

A summary of the Committee’s discussion is contained in the meeting minutes². The MARC concluded that:

• Efficacy studies had demonstrated that these medicines were no better than paracetamol used at the maximum recommended dose.
• The available data on adverse reactions showed that these medicines have the potential to cause more adverse reactions than paracetamol used at recommended doses.
• These medicines are more dangerous than other analgesics in overdose.
• Overall the benefits of these medicines do not outweigh the risks associated with their use.

To protect the health of New Zealanders the MARC recommended consent to distribute these medicines in New Zealand be revoked. The MARC has also recommended that physicians be given sufficient time to review patients and arrange alternative treatments.

Medsafe is currently implementing the MARC’s recommendations. In the interim Medsafe advises prescribers not to start any new patients on dextropropoxyphene containing medicines such as Paradex or Capadex and to start reviewing the analgesic requirements of patients currently taking these medicines.

Medsafe will issue further details regarding the withdrawal of dextropropoxyphene containing medicines in due course.

References

1. Medsafe Editorial Team. 2005. Dextropropoxyphene-paracetamol combination products and risk of overdose. Prescriber Update 27(2): 21-22.
2. Ministry of Health. 3 December 2009. Minutes of the 140^th meeting of the Medicines Adverse Reaction Committee. Wellington.
   www.medsafe.govt.nz/profs/adverse/Minutes140.htm