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

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
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 2,500+ scientific posters on ePosters
  • More Than 3,700+ 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 TechnologyNetworks.com 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

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
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
LaVision BioTec Reports on the Neuro Research on the Human Brain After Trauma
Company reports on the work of Dr Ali Ertürk from the Institute for Stroke and Dementia Research at LMU Munich.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Less May Be More in Slowing Cholera Epidemics
Mathematical model shows more cases may be prevented and more lives saved when using one dose of cholera vaccine instead of recommended two doses.
Investigating the Vape
Expert independent review concludes that e-cigarettes have potential to help smokers quit.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Researchers Discover Synthesis of a New Nanomaterial
Interdisciplinary team creates biocomposite for first time using physiological conditions.
Poor Survival Rates in Leukemia Linked to Persistent Genetic Mutations
For patients with an often-deadly form of leukemia, new research suggests that lingering cancer-related mutations – detected after initial treatment with chemotherapy – are associated with an increased risk of relapse and poor survival.
Flu Remedies Help Combat E. coli Bacteria
Physiologists from the University of Zurich have now discovered why the intestinal bacterium Escherichia coli (E. coli) multiplies heavily and has an inflammatory effect.
Marijuana Genome Unraveled
A study by Canadian researchers is providing a clearer picture of the evolutionary history and genetic organization of cannabis, a step that could have agricultural, medical and legal implications for this valuable crop.
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!