EMA restricts use of metoclopramide-containing medicines for nausea

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, including restricting the dose and duration of use of the drugs to minimize the known risks of potentially serious neurological side effects.

Metoclopramide-containing medicines have been authorized separately in individual member states of the EU, with differing licensed indications such as nausea and vomiting (for example after treatment with anticancer chemotherapy or radiotherapy, after surgery, or associated with migraine) and gastrointestinal motility disorders.

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. The 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).