Other safety alerts
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| The United States: FDA Requested manufacturers of propoxyphene-containing products to withdraw from the U.S. market |
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The US Food and Drug Administration (FDA) requested that all manufacturers of propoxyphene-containing products to voluntarily withdraw their products from the U.S. market.
The decision was made after the FDA received new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data and other information including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.
For details, please refer to the following FDA website:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm
Situation in Hong Kong: Propoxyphene is available as dextropropoxyphene and there are 22 registered products containing dextropropoxyphene. It is an opioid analgesic for the alleviation of mild to moderate pain. All dextropropoxyphene-containing products can only 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In June 2009, the European Medicines Agency (EMA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union.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 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 Registration Committee.
Ends/Saturday, November 20, 2010
Issued at HKT 17:30 |
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