HSA Updates
HSA Requests Singapore Pharmaceutical Pte Ltd to Suspend Dextropropoxyphene Sales (Dolpoxene®, Dolpocetmol®)
Audiences
Consumer
Healthcare professional
Industry member
Product type
Others
9 November 2009
This article has been migrated from an earlier version of the site and may display formatting inconsistencies.
The Health Sciences Authority (HSA) has requested Singapore Pharmaceutical Pte Ltd to suspend the sales of dextropropoxyphene-containing products with effective from 9 November 2009 due to the findings that the risk benefit profile of dextropropoxyphene is no longer favourable.
2 Dextropropoxyphene is a weak synthetic opioid analgesic and is licensed for the treatment of mild to moderate pain. It is marketed in Singapore as Dolpoxene®, which contains only dextropropoxyphene and Dolpocetmol®, which contains a combination of dextropropoxyphene and paracetamol.
HSA's risk-benefit assessment of dextropropoxyphene
3 HSA has been closely monitoring the safety profile of dextropropoxyphene following withdrawal of dextropropoxyphene-containing products by UK in 2005 and the European Union in June 2009. Based on the assessment of the data available to-date, HSA and its Pharmacovigilance Advisory Committee (PVAC) have concluded that the risk of dextropropoxyphene outweighs its benefits in the treatment of mild to moderate pain.
4 The review took into consideration the following factors:
The limited therapeutic efficacy of dextropropoxyphene as compared to commonly used analgesics;
The availability of other therapeutic alternatives such as paracetamol, NSAIDs and opioids; and
The potential risk of fatal overdose associated with dextropropoxyphene as well as the risk-benefit assessments of other regulatory agencies.In addition, it has also been highlighted in several literature articles that norpropoxyphene, the metabolite of dextropropoxyphene, has been associated with cardiac toxicities.
5 The potential risk of fatal overdose with dextropropoxyphene and cardiac toxicities associated with its metabolite, norpropoxyphene are considered unacceptable in view of dextropropoxyphene's modest efficacy. As such, the importation, sales and marketing of Dolpoxene® and Dolpocetmol® at the wholesale level was suspended with effect from 9 November 2009.
HSA's Advisory
6 Patients who are taking this medicine should consult their doctors for an assessment of treatment alternatives based on their individual medical situation and needs.
7 Healthcare professionals are advised not to initiate new patients on dextropropoxyphene therapy and to consider alternative treatment options for their patients who may be currently on dextropropoxyphene products for pain relief.
HEALTH SCIENCES AUTHORITY
SINGAPORE
9 NOVEMBER 2009