Other safety alerts
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| Canada: Recall and withdrawal of Darvon-N (dextropropoxyphene) |
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In collaboration with Health Canada, Paladin Labs Inc. has decided to voluntarily recall and withdraw all lots of Darvon-N (dextropropoxyphene, also known as propoxyphene) on the Canadian market and discontinue the sale of the product. This decision follows a United States Food and Drug Administration (FDA) request that all manufacturers of propoxyphene, an opioid pain reliever used to treat mild to moderate pain, withdraw their products from the U.S. market The withdrawal is based on all available data, including data from a new study that evaluated the effects of increasing doses of dextropropoxyphene on the heart.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/darvon-n_pc-cp-eng.php
In Hong Kong, propoxyphene is available as dextropropoxyphene and there are 22 registered products containing dextropropoxyphene. All dextropropoxyphene containing products can be sold at pharmacy under the supervision of pharmacist. In June 2009, the European Medicines Agency (EMA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. In July 2009, the FDA permitted the continued marketing of propoxyphene-containing products but requested the manufacturer to conduct new safety study about the effects of propoxyphene on the heart. The issue had been discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board in July 2009 and the Committee recommended continued monitoring of the local situation and action in other countries. In view of the new clinical information and latest decision by FDA, the above issue will be considered in the next meeting of the Committee. This updated information was posted on the website of Pharmaceutical Service on November 20, 2010. Letter to Healthcare Professionals was issued on November 22, 2010. Press release regarding Department of Health’s position on propoxyphene-containing pharmaceutical products was issued on November 26, 2010. Any actions from other health authorities will be kept in view.
Ends/Thursday, December 2, 2010
Issued at HKT 14:30
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