Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

EMA recommends metoclopramide restrictions

The European Medicines Agency has recommended changes to the use of metoclopramide to reduce the risk of neurological side effects.

The review of metoclopramide, carried out at the request of the French medicines regulatory agency, confirmed the well-known risks of neurological effects including:

  • extrapyramidal disorders
  • involuntary movement disorders that may include muscle spasms
  • tardive dyskinesia

It was noted that the risk of side effects is increased at high doses or with long-term treatment.

The review has recommended that treatment duration is restricted to short-term use (up to 5 days) and that the maximum dose is limited (in adults to 10mg three times daily). It is also recommended that metoclopramide is not used in children under 1 year old.

Metoclopramide is only recommended for:

  • prevention of post-operative nausea and vomiting (PONV) in adults
  • radiotherapy-induced nausea and vomiting in adults
  • delayed (but not acute) chemotherapy-induced nausea and vomiting in adults
  • symptomatic treatment of nausea and vomiting including that associated with acute migraine in adults
  • second-line option for prevention of delayed chemotherapy-induced nausea and vomiting in children
  • treatment of established PONV in children

Action: Clinicians should be aware of these new restrictions and implement any necessary changes to current practice.

Thanks to Kevin Ashworth for spotting this article

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One Comments to “EMA recommends metoclopramide restrictions”

  1. […] treatment stopped or an appropriate alternative issued. This section also contains a summary of the recently issued European Medicines Agency advice recommending that the dose and duration of use for metoclopramide […]

    Pingback by Drug Safety Update – August 2013 | Prescribing Advice for GPs — August 13, 2013 #
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