Primperan-dos

EMA:s beslut att rekommendera sänkt maxdos av mteoklopramid har engagerat palliativa läkare i Europa, vilket föranlett kontakt med EMA, vg se kopia på inlägg nedan från www.palliativedrugs.com. Tolkar detta svar som att man menar att vi inom palliativ vård kan fortsätta använda metoklopramid i de doser vi gjort hittills.

 Re: Metoclopramide review

Posted by: Doctor Trevor Rimmer (IP Logged)

Date: August 28, 2013 05:14PM

 

I was concerned and wrote to the EMA. They were courteous and sent a quick reply;
Paul Blake, Medical Information (address European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom. E-mail info@ema.europa.eu) ansered.

This was his reply.

"Thank you for your email of 08 August concerning the recommendations for changes to the license for metoclopramide, and the role of the medicine in palliative care.

The CHMP recommendations were based on careful analysis of the evidence for efficacy and safety of metoclopramide in its licensed indications. Very limited high quality data was found in support of the efficacy of metoclopramide in the majority of these indications, but there was a clear risk of potentially serious neurological reactions.

Since use in palliative care was not a licensed indication for metoclopramide-containing medicines, the CHMP evaluation did not specifically examine such use. The aim of the review was to examine the evidence for efficacy and safety in the licensed indications, and to restrict the use of metoclopramide to those of the existing indications in which reliable evidence supported a favourable benefit-risk balance.

We understand that palliative care often requires the use of medicines outwith their standard licensed indications since few medicines are specifically studied and licensed for use in terminally ill patients, in whom the balance of risks and benefits may differ from other patient groups. Presumably, even if the licensed indications for metoclopramide are restricted in line with CHMP advice, this will continue to be true, and if off-label metoclopramide was previously recognised as standard practice by specialists in palliative care, that should not necessarily change as a consequence of the CHMP’s review. In theory, therefore, there is no reason that the changes in the licensed product information for metoclopramide should prevent the use of the medicine in the situations described in your email."

Thus we can still use metoclopramide as with other drugs, with the provisos of unlicensed use for dose and route.

 
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