E-DRUG: Status of Dextropropoxyphene? (2)
Dextropropoxyphene is a structurally similar weak opioid analgesic as
propoxyphene with similar pharmacological profile and toxicity. There have been
concerns for some years over the risk of death from overdose � both intentional
and accidental � in patients taking medicines containing dextropropoxyphene and
Approx. one year ago, on 21 October 2009, the European Medicine Agency based on
a safety review, recommended the withdrawal of all non-parenteral dosage form
containing dextropropoxyphene in EU member countries.
For the parenteral form (solution for injection) that is usually used in
hospitals under controlled condition, it was recommended that the marketing
authorisations be suspended until further data are available on its safety.
You can find more details about this decision on EMA website
Combination analgesic paracetamol (325 mg) and dextropropoxyphene (32.5 mg)
known as co-proxamol was withdrawn from the market in Ireland as of January
This article analysing impact of withdrawal after January 2006 of this products
on intentional drug overdose found positive benefits, supportive of the
Corcoran P et al., Use of analgesics in intentional drug overdose
presentations to hospital before and after the withdrawal of distalgesic from
the Irish market.BMC Clin Pharmacol. 2010 Mar 18;10:6.
Dr. Klara Tisocki, B.Pharm., M.Sc., Ph.D.
Consultants for Health and Development BV
2352 AZ Leiderdorp,
Tel: +31 71 7503240
Mobile: +31 643 536597
Fax: +31 71 5233592