Revised: 9 February 2010
Publications
Paradex and Capadex to be withdrawn from New Zealand market
All medicines containing dextropropoxyphene will be withdrawn from the New Zealand market after a review of the safety and efficacy of these medicines showed that their risks outweighed their possible benefits.
Medicines containing dextropropoxyphene are analgesics used to treat chronic moderate pain. Two medicines containing dextropropoxyphene are currently approved for use in New Zealand - Paradex tablets and Capadex capsules.
After reviewing the available evidence, the Medicines Adverse Reactions Committee (MARC), which advises the Minister of Health on medicines safety issues, 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.
Medsafe Group Manager Dr Stewart Jessamine said the withdrawal will be gradual to allow time for the safe transfer of patients to alternative treatments.
"Medsafe is working to implement these recommendations and ensure that the withdrawal is as smooth as possible. The withdrawal will not be immediate to allow time for patients to transfer to alternative treatments," Dr Jessamine explained.
Medicines containing dextropropoxyphene have been withdrawn in several other countries, most notably the United Kingdom. The European Medicines Agency and Singapore have recently announced they are also withdrawing these medicines.
When dextropropoxyphene was withdrawn in the United Kingdom it was replaced with other pain killers, mostly by paracetamol alone, codeine alone, or a combination of codeine and paracetamol.
Any patient who is currently being treated with Paradex or Capadex should continue to take their medicines. Those patients who regularly take these medicines will need to see their GP to discuss alternative treatment options.
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
- More information is available as a Question and Answer. www.medsafe.govt.nz/hot/media/2010/QandACapadexandParadex.asp
- Dextropropoxyphene is a pain killer, belonging to the opioid class of medicines (which also includes codeine).
- In 2009, 78,000 patients were estimated to be taking dextropropoxyphene-containing medicines in New Zealand.
- 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
- The MARC first reviewed the use of Capadex and Paradex in 2005 and considered the balance of benefits and risks to be unfavourable for the majority of patients. After consultation with healthcare professionals, the MARC accepted that there was a clinical need for these products in a select group of patients. Medsafe introduced prescribing restrictions to limit use of these medicines to patients for whom healthcare professionals had indicated there was a clinical need. The MARC also requested that a medicines utilisation study be conducted to monitor the effect of the new restrictions. A study conducted for Paradex showed that less than half of the prescriptions issued were in accordance with the new restrictions. A significant number of prescriptions were also issued to children. The MARC noted that New Zealanders were therefore, still being exposed to a medicine previously considered to have an unfavourable benefit risk balance. Therefore, a statutory review of the benefits and risks of these medicines was initiated under section 36 of the Medicines Act 1981.
- Section 36 of the Medicines Act 1981 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 these data is unfavourable the Minister of Health may take action, including prohibiting the supply of medicine or removing the medicine from the market.
- The data sheet is a summary of the known effects of a medicine, and includes information on the approved uses of the medicine (indications) and is supplied and maintained by the pharmaceutical company. Data sheets for Capadex and Paradex are published on the Medsafe website www.medsafe.govt.nz/Medicines/infoSearch.asp However, please note that during the MARC review it was highlighted that the product information for similar products in the US had recently been updated making the New Zealand data sheets out of date.
- Medsafe is the New Zealand Medicines and Medical Devices Safety Authority, and is part of the Ministry of Health.
For queries, please contact: Luz Baguioro, Media Advisor (04 496 2349, 021 802 622)
