June 26, 2009
European Watchdog Group Calls for Pain Medicine Recall
A European watchdog group is calling for a painkiller that has been used for over 40 years to be taken off shelves, insisting that its risks are greater then its benefits.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) said on Thursday that medicine that has dextropropoxyphene is not more successful than other, safer painkillers.
The Committee stated in a press release that it was advising that these medicines be removed from stores across the European Union.
The steps to remove the medication would be ongoing to allow safer alternative medications to replace them, specifically ones that follow national recommendations, it said.
Taken for serious pain, dextropropoxyphene has been on the market for 40 years, the CHMP said.
Worries over fatal overdoses have caused several countries to conduct independent safety studies of products made with the drug. Although these studies resulted in different conclusions, several states have banned dextropropoxyphene medications while others are still authorizing them.
The European Commission stated that, "in order to provide for a harmonized level of protection of public health across the European Union," conducted a complete review both of medicines containing dextropropoxyphene and paracetamol and dextropropoxyphene by itself.
"The available data have not provided evidence that dextropropoxyphene-containing medicines are more effective than other alternative painkillers," the CHMP said.
"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measures could be identified to minimize these risks sufficiently, the CHMP recommended that these medicines should be withdrawn from the market."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 proposal has been sent to the European Commission for the creation of a legally binding law, it added.
Medicines containing dextropropoxyphene are available in Belgium, Denmark, Finland, France, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden.
Medicines combining dextropropoxyphene and paracetamol are on the market in Belgium, Cyprus, France, Luxembourg, Malta, and Portugal, as well as in Norway, which is not a EU member.
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