Mental HealthEuropean Medicines Agency Recommends Withdrawal Of Dextropropoxyphene-containing Medicines
Finalising a review of the safety and efficacy of
dextropropoxyphene-containing medicines, the European Medicines Agency"s
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the marketing authorisations for these medicines be withdrawn across the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.
Dextropropoxyphene is a painkiller used to treat acute and chronic pain.
It has been available as a prescription-only medicine for about 40
years, either on its own or in combination primarily with paracetamol,
as tablets, capsules, suppositories and solutions for injection.
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 authorised 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 harmonised level of protection of public
health across the European Union, the European Commission asked the
European Medicines Agency, 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 authorisations 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maintained, varied, suspended or withdrawn.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 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withdrawn from the market.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.
Note
1. More information is available in a question-and-answer
document.
2. The review was initiated by the European Commission under Article 31
of Directive 2001/83/EC, as amended. This type of procedure may be
initiated in specific cases where the interest of the Community is
involved. The expression "Community interest" has a broad meaning but it
refers particularly to the interests of the public health in the
Community, for example following concerns related to the quality,
efficacy and/or safety of a medicinal product or new pharmacovigilance
information.
3. Medicines containing dextropropoxyphene on its own are authorised in
10 Member States (Belgium, Denmark, Greece, Spain, Finland, France,
Italy, Luxembourg, the Netherlands and Sweden) and medicines containing
dextropropoxyphene combined with paracetamol (sometimes with caffeine)
are authorised in six Member States (Belgium, Cyprus, France,
Luxembourg, Malta, and Portugal) and Norway.
EMEA