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[e-farmacos] UK: retira co-promaxol (paracetamol+dextropropoxifeno)


  • From: "Madurga, Mariano" <mmadurga@agemed.es>
  • Date: Tue, 1 Feb 2005 16:51:07 +0100

Estimadas y estimados amigos,

La agencia britanica MHRA, en coordinacion con el Committee on Safety
Medicines (CSM) ha comunicado la retirada del mercado britanico de los
medicamentos con co-promaxol, asociacion a dosis fijas de paracetamol
(325 mg) y dextropropoxifeno (32,5 mg). Cada anho entre 300 y 400 muertes en
Inglaterra y Gales se relacionan con el uso de esta asociacion analgesica
por intoxicaciones accidentales o intencionadas. La quinta parte se
consideran accidentales.

INFORMACION de la MHRA:
The CSM has announced that, in order to minimize disruption of healthcare
provision, co-proxamol will be phased out so that patients currently
receiving co-proxamol may be switched to alternative pain management regimes
at their next routine medication review. The CSM has issued the following
interim prescribing advice, pending withdrawal of co-proxamol

- Co-proxamol is only indicated in the treatment of mild to moderate
pain in adults where first line analgesics have proved ineffective or are
inappropriate. It should not be used for any acute pain management.

- Co-proxamol therapy should not be initiated in new patients
- Co-proxamol should not be used patients aged < 18 years
- Co-proxamol is contraindicated in patients who are
alcohol-dependent, who are likely to consume alcohol whilst taking
co-proxamol, and in those patients who are suicidal or addiction prone.

The full details of this posting are available on the MHRA website at:
www.mhra.gov.uk

Un abrazo,

Mariano

Mariano Madurga
Division de Farmacoepidemiologia y Farmacovigilancia
Agencia Espanhola de Medicamentos y Productos Sanitarios
28220-Majadahonda, Madrid
Correo-e: mmadurga@agemed.es
Web: www.agemed.es