EMEA Recommends Withdrawal of Dextropropoxyphene-Containing Medicines LONDON -- June 25, 2009 -- Finalizing a review of the safety and efficacy of dextropropoxyphene-containing medicines, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) concluded that their risks, particularly the risk of potentially fatal overdose, are greater than their benefits. The Committee therefore recommended that the marketing authorizations for these medicines be withdrawn across the European Union. The withdrawal will be gradual to allow time for the safe transfer of patients to appropriate alternative therapies, in line with national recommendations. There have been concerns over intentional and accidental fatal overdose with dextropropoxyphene-containing medicines for some years and a number of Member States had carried out independent safety reviews of these medicines authorized in their territories. These reviews have led to different conclusions, with some Member States withdrawing dextropropoxyphene-containing medicines from, and others maintaining them on, their markets. In order to provide for a harmonized level of protection of public health across the EU, the European Commission asked the EMEA, in November 2007, to carry out a full assessment of the benefits and risks of combination-medicines containing dextropropoxyphene and paracetamol. This assessment was to determine whether the marketing authorizations for these medicines should be maintained, varied, suspended or withdrawn. Later, the procedure was extended to medicines that contain dextropropoxyphene as the only active substance. The available data have not provided evidence that dextropropoxyphene-containing medicines are more effective than other alternative painkillers. However, data from forensic centers and national mortality statistics from several Member States showed a significant number of deaths associated with overdose. Because no other adequate measures could be identified to minimize these risks sufficiently, the CHMP recommended that these medicines should be withdrawn from the market. The Agency's recommendation has been forwarded to the European Commission for the adoption of a legally binding decision. In the United States, dextropropoxyphene is available as a prescription formulation with paracetamol (acetaminophen) in ratio anywhere from 30 mg / 600 mg to 100 mg / 650 mg (or 100 mg / 325 mg in the case of Balacet), respectively. These are usually named Darvocet. On the other hand, Darvon is a pure propoxyphene preparation available in the US that does not contain paracetamol. In Australia, dextropropoxyphene is available both as a combined product (32.5 mg dextropropoxyphene per 325 mg paracetamol) branded as either Di-gesic, Capadex, or Paradex, and in pure form (100 mg capsules) known as Doloxene. Trade-names also include co-proxamol (UK) and Lentogesic (South Africa). In the UK, dextropropoxyphene and co-proxamol are now discouraged from general use; and, since 2004, preparations containing only dextropropoxyphene have been discontinued On January 30, 2009, it was reported that the US Food and Drug Administration (FDA) was conducting a hearing to determine the safety of dextropropoxyphene. According to reports, a total of 314 propoxyphene-related deaths reported in Florida, 85, or 25%, were cases in which the medical examiner concluded that the drug was a cause of death. An FDA panel voted to recommend that dextropropoxyphene be removed from the market, based on its weak pain killing abilities, addictiveness, association with drug deaths, and possible heart problems, including arrhythmia. Dextropropoxyphane carries a Black Box Warning in the US, the strongest warning given by the FDA. SOURCE: European Medicine Agency ************************************* FAIR USE NOTICE: The Fibromyalgia Community Newsletter contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of environmental, political, human rights, economic, democracy, scientific, and social justice issues, etc. We believe this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material in The Fibromyalgia Community Newsletter is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. For more information go to: http://www4.law.cornell.edu/uscode/17/107.html.If you wish to use copyrighted material from The Fibromyalgia Community Newsletter for purposes of your own that go beyond 'fair use', you must obtain permission from the copyright owner.