Restricted dose and duration of use.
Article date: August 2013
The European Medicines Agency’s Committee on Medicinal Products for Human Use has reviewed the benefits and risks of the antiemetic metoclopramide. The review was done at the request of the French medicines regulatory agency (ANSM), following concerns over side effects and efficacy. The review confirmed the well known risks of neurological effects such as short-term extrapyramidal disorders and tardive dyskinesia. The conclusion of the review was that these risks outweigh the benefits in long-term or high-dose treatment.
The EU review has recommended changes that include a restriction to the dose and duration of use to help minimise the risk of potentially serious neurological adverse effects. The risk of acute neurological effects is higher in children than in adults.
Advice for healthcare professionals
Indications and use in adults and children:
- in adults, metoclopramide remains indicated for:
- prevention of postoperative nausea and vomiting
- radiotherapy-induced nausea and vomiting
- delayed (but not acute) chemotherapy-induced nausea and vomiting
- symptomatic treatment of nausea and vomiting, including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics)
- in children, age 1–18 years, metoclopramide should only be used as a second-line option for prevention of delayed chemotherapy-induced nausea and vomiting, and for treatment of established postoperative nausea and vomiting
- use of metoclopramide is contraindicated in children younger than 1 year
- metoclopramide should only be prescribed for short-term use (up to 5 days)
- for adults, the maximum dose in 24 hours is 30 mg (or 0.5 mg per kg bodyweight) - the usual dose is 10 mg up to three times a day
- in children age 1 year or older, the recommended dose is 0.1–0.15 mg per kg bodyweight, repeated up to 3 times a day - the maximum dose in 24 hours is 0.5 mg per kg bodyweight
- intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects
- oral liquid formulations should be given via an appropriately designed, graduated oral syringe to ensure dose accuracy in children
Article citation: Drug Safety Update vol 7 issue 1, August 2013: S2.