Media Release

4 September 2009

Medsafe reviews dextropropoxyphene-containing medicines: Capadex and Paradex

Medsafe has started a statutory review of the safety and efficacy of all medicines containing dextropropoxyphene, Medsafe’s Group Manager Dr Stewart Jessamine said.

Medicines containing dextropropoxyphene are analgesics used to treat chronic moderate pain. Two medicines containing dextropropoxyphene are currently approved for use in New Zealand. The brand names of these products are Capadex and Paradex. Further information about these medicines is available on their data sheets on the Medsafe website (www.medsafe.govt.nz).

“Should this review show that the balance of risks and benefits is unfavourable, this may lead to the withdrawal of these medicines in New Zealand. At the earliest, a final decision on the outcome will not be available until the last quarter of the year,” Dr Jessamine said.

Medsafe initially reviewed the safety of these medicines in 2005. There were concerns around the risk of fatal heart problems, depression of breathing and coma especially in overdose. It was noted that some overdoses had occurred accidentally. Following consultation with healthcare professionals, Medsafe concluded that there was a clinical need for these products for some patients.

In late 2005, Medsafe introduced prescribing restrictions to limit use of these medicines to those patients most likely to benefit from their use. In addition, Medsafe required the manufacturers of these medicines to conduct a drug utilisation study to determine if the restrictions had produced changes in prescribing behaviour.

Dr Jessamine said the results of the study investigating the use of these medicines was reviewed by the Medicines Adverse Reactions Committee (MARC) in June this year.

“The study showed that over half the prescriptions issued for Paradex were not in accordance with the prescribing restrictions. In addition, a significant number of prescriptions were issued for patients, including children, and the treatment of conditions outside of those assessed and approved by Medsafe.”

The MARC concluded that the restrictions on the use of Capadex and Paradex have not changed prescribing habits and recommended to Medsafe that it review the benefits and risks of the continued availability of these medicines.


ENDS

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Additional information

• The Medicines Adverse Reactions Committee (MARC) advises the Minister of Health on medicines safety issues.
  
• Details of the 2005 review of dextropropoxyphene containing products can be found in the Minutes of the MARC:
  (http://www.medsafe.govt.nz/profs/adverse/Minutes138.htm#3.2)
  (http://www.medsafe.govt.nz/profs/adverse/minutes122.htm#2.2.7)
  
• Medsafe is the New Zealand medicines and medical devices safety authority, and is a business unit of the Ministry of Health.
  
• A statutory review of the risks and benefits of a medicine is mandated by Section 36 of the Medicines Act 1981. Section 36 of the Act gives the Director-General of Health the power to require a medicine sponsor to supply information to support the efficacy and safety of that medicine. If a review of this data is unfavourable, the Minister of Health may then prohibit the supply of the medicine.
  
• The data sheet is a summary of the known effects of a medicine, and includes information on the approved uses of the medicine (indications). Data sheets are published on the Medsafe website (http://www.medsafe.govt.nz/).
  
• The approved indications of Paradex and Capadex are “for the relief of chronic pain of moderate severity. These medicines should only be prescribed to patients in whom treatment of therapeutic doses of alternative therapeutic groups, including combination products, have been used and found to lack analgesic efficacy or have unacceptable adverse effects in the individual patient.”
  
• Paradex is not recommended for administration to children.
  
• The administration of Capadex is not recommended for children under 14 years.
  
• Medsafe is aware that the European Medicines Agency (EMEA) has completed a review of the safety and effectiveness of dextropropoxyphene-containing medicines and concluded that the benefits of dextropropoxyphene do not outweigh its risks. Therefore, the EMEA is recommending that all dextropropoxyphene-containing products are withdrawn in Europe. The timing of product withdrawal will be decided by the medicines regulatory agency of each country.
  
• Medsafe is aware that the US Food and Drug Administration is taking action to improve the safe use of medicines containing propoxyphene (dextropropoxyphene). The FDA has not recommended that these medicines are withdrawn.