A European medical watchdog called Thursday for a painkiller in use for 40 years to be withdrawn, saying its risks, notably of fatal overdose, outweighed its benefits.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) said medicines containing dextropropoxyphene had also not been shown to be more effective than other painkillers.
AdvertisementThe Committee said in a press release Thursday that it was recommending such medicines, in use in a dozen member states, be withdrawn across the European Union.
The withdrawal would be gradual to allow time for the safe transfer of patients to appropriate alternative therapies, in line with national recommendations, it said.
Used to treat acute and chronic pain, dextropropoxyphene has been available as a prescription-only medicine for about 40 years, either on its own or in combination primarily with paracetamol, the CHMP said.
Concerns over intentional and accidental fatal overdoses for some years had led a number of countries to carry out independent safety reviews of products containing the drug.
However these reviews produced different conclusions, with some states banning dextropropoxyphene-containing medicines and others continuing to authorise them.
At the request of the European Commission, "in order to provide for a harmonised level of protection of public health across the European Union," the European Medicines Agency carried out a full assessment both of medicines containing dextropropoxyphene and paracetamol and dextropropoxyphene alone.
"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 centres 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measures could be identified to minimise these risks sufficiently, the CHMP recommended that these medicines should be withdrawn from the market."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, it added.
Medicines containing dextropropoxyphene on its own are authorised in Belgium, Denmark, Finland, France, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden.
Medicines containing dextropropoxyphene combined with paracetamol (sometimes with caffeine) are authorised in Belgium, Cyprus, France, Luxembourg, Malta, and Portugal, as well as in Norway, which is not an EU member.
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