European Medicines Agency Recommends Changes to the Use of metoclopramide
News Jul 26, 2013
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.