Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

European Medicines Agency Recommends Changes to the Use of metoclopramide

Published: Friday, July 26, 2013
Last Updated: Friday, July 26, 2013
Bookmark and Share
Changes aim mainly to reduce the risk of neurological side effects.

The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) has recommended changes to the use of metoclopramide-containing medicines in the European Union (EU), including restricting the dose and duration of use of the medicine to minimise the known risks of potentially serious neurological (brain and nerve) side effects.

Metoclopramide-containing medicines have been authorised separately in individual Member States of the EU, with differing licensed indications such as nausea and vomiting of various causes (for example after treatment with anticancer chemotherapy or radiotherapy, after surgery, or associated with migraine) and gastrointestinal motility disorders (conditions in which the normal passage of food through the gut is delayed).

The review of metoclopramide was carried out at the request of the French medicines regulatory agency (ANSM), following continued safety concerns over side effects and concerns over efficacy. ANSM asked the CHMP to review the benefits and risks of these medicines in all age groups and to recommend consistent indications across the EU. The review confirmed the well-known risks of neurological effects such as short-term extrapyramidal disorders, a group of involuntary movement disorders that may include muscle spasms (often involving the head and neck), and tardive dyskinesia (uncontrollable movements such as grimacing and twitching). The risk of acute (short-term) neurological effects is higher in children, although tardive dyskinesia is reported more often in the elderly, and the risk is increased at high doses or with long-term treatment. The evidence indicated that these risks outweighed the benefits of metoclopramide in conditions requiring long-term treatment. There have also been very rare cases of serious effects on the heart or circulation, particularly after injection.

The Committee recommended that metoclopramide should only be prescribed for short-term use (up to 5 days), that it should not be used in children below 1 year of age and that in children over 1 year of age it should only be used as a second-choice treatment (after other treatments have been considered or tried) for the prevention of delayed nausea and vomiting after chemotherapy and for the treatment of post-operative nausea and vomiting. In adults, it may be used for the prevention and treatment of nausea and vomiting such as that associated with chemotherapy, radiotherapy, surgery and in the management of migraine. In addition, the maximum recommended doses in adults and children should be restricted, and higher strength formulations removed from the market.

Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More Than 5,200+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

EMA: Reduce Colistin Use in Animals
The EMA has updated its 2013 advice on the use in animals of colistin.
Monday, August 01, 2016
First DNA Vaccine in the EU Recommended for Use in Salmon
Clynav to protect Atlantic salmon from serious infectious disease.
Saturday, April 23, 2016
EU Drug Regulator Recommends 1st License for Malaria Shot
Mosquirix to be used for vaccination of young children, together with established antimalarial interventions.
Monday, July 27, 2015
First Stem-Cell Therapy Recommended For Approval In EU
New treatment for rare condition caused by burns to the eye.
Monday, December 22, 2014
European Medicines Agency Launches Adaptive Licensing Pilot Project
Improving timely access for patients to new medicines: pilot explores adaptive licensing approach with real medicines in development.
Friday, March 21, 2014
Investigation Into GLP-1 Based Diabetes Therapies Concluded
No new concerns for GLP-1 therapies identified on the basis of available evidence.
Friday, July 26, 2013
European Medicines Agency Reorganisation
Re-shaping a regulatory agency fit for the future.
Friday, May 03, 2013
Meeting highlights from the Pharmacovigilance Risk Assessment Committee
Outcome of periodic safety update report assessment leads to recommendation to restrict use of a medicine.
Monday, April 15, 2013
EU Agencies Consider Phenylbutazone Detected in Horsemeat of Low Concern for Consumers
Agencies recommend improved horse traceability and monitoring of veterinary medicinal residues.
Monday, April 15, 2013
European Medicines Agency Gives First Opinion for a Vaccine for Use Outside the EU
New vaccine offers protection against six WHO priority diseases.
Monday, June 25, 2012
Scientific News
Integrated Omics Analysis
Studying multi-omics promises to give a more holistic picture of the organism and its place in its ecosystem, however despite the complexities involved those within the field are optimistic.
Unravelling the Role of Key Genes and DNA Methylation in Blood Cell Malignancies
Researchers from the University of Nebraska Medical Center have demonstrated the role of Dnmt3a in safeguarding normal haematopoiesis.
Salford Lung Study - The First Real World Clinical Trial
In this podcast, we learn about the Salford Lung Study and its potential to revolutionize the way we assess new drugs and treatments around the world.
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Zika Virus Infection Alters Human and Viral RNA
Researchers have discovered that Zika infections results in human and viral genetic modification.
RNA-Binding Proteins Role in ALS Revealed
Researchers describe how damage to RNA-binding protein contributes to ALS, isolating a possible therapeutic target.
MRIs for Fetal Health
Algorithm could help analyze fetal scans to determine whether interventions are warranted.
Illumina Contributes to ClinVar Database
The contribution includes variants of all classifications, from pathogenic to benign, identified during interpretation of whole genome sequences generated in the CLIA-certified, CAP-accredited Illumina Clinical Services Laboratory.
Structure of Primary Cannabinoid Receptor is Revealed
The findings provide key insights into how natural and synthetic cannabinoids including tetrahydrocannabinol —a primary chemical in marijuana—bind at the CB1 receptor to produce their effects.
Overlooked Molecules Could Revolutionise our Understanding of the Immune System
Researchers have discovered that around one third of all the epitopes displayed for scanning by the immune system are a type known as ‘spliced’ epitopes.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,200+ scientific videos