Download TGA to cancel ALL dextropropoxyphene products The TGA

TGA to cancel ALL dextropropoxyphene products
The TGA announced earlier this week their decision to cancel the registration of ALL
dextropropoxyphene-containing analgesics from 1st March 2012.
Four products will be removed from the Australian market:
Paracetamol 325mg/Dextropropoxyphene HCl 32.5mg tablets/capsules:



Di-Gesic
Capadex
Paradex
Dextropropoxyphene Napsylate 100mg capsules, "Doloxene"
The TGA, in considering all available evidence, concluded that the safety concerns with
dextropropoxyphene outweighed the limited evidence of it's benefits over other avalable
analgesics. The regulator cited recent evidence of cardiac toxicity, with adverse effects on
electrical conductivity increasing the risk of serious and potentially fatal arrhythmias being
demonstrated in therapeutic doses. The elderly and those with renal impairment are at
particular risk of accumulation of the drug and it's cardiotoxic metabolite, norpropoxyphene.
The advance notice of cancellation is to allow time for patients taking these analgesics to see
their doctors and be converted to alternative analgesics.
Given the substantial usage in Private Acute Care Facilities, particularly in the
post-operative and post-partum settings, the 3 months advance notice will
allow prescribers time to transition their prescribing practices to alternative
analgesics.
To read the TGA announcement, click here.
Withdrawal of dextropropoxyphene-containing analgesics from the market brings Australia
in line with several other countries that withdrew the drug in the past 12 months including the
United States, Canada, Europe, New Zealand, and the United Kingdom which phased out the
products 2005-2007.
NPS, the Australian not-for-profit Quality Use of Medicines organisation have also publicly
endorsed the TGA's decision.
The Australian sponsor of all four products, Aspen Pharmacare, is appealing the decision
under the provisions of the Therapeutic Goods Act.