Metoclopramide: Stronger warnings on risk of abnormal muscle movements

Starting date:

July 20, 2011

Posting date:

July 20, 2011

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Labelling and Packaging

Audience:

General Public

Identification number:

RA-110005226

• Media enquiries
• Public enquiries

Health Canada is informing health professionals and consumers that the labelling information for the drug metoclopramide is being updated to include stronger warnings on the risk of a movement disorder known as "tardive dyskinesia." The disorder is characterized by uncontrollable muscle movements, mainly in the face. The risk increases with longer treatment and is higher in the elderly, especially elderly women.

Metoclopramide, available in Canada since 1975, is a prescription drug. It is most commonly used to treat digestive problems associated with a stomach that empties too slowly. It works by helping speed the movement of food through the stomach and intestines. (See below for a list of metoclopramide drugs in Canada.)

Tardive dyskinesia is a known side effect associated with metoclopramide. The current prescribing information contains information on this risk. Health Canada is working with the Canadian manufacturers to include stronger, more detailed warnings in the drug labelling that contain the following information:

• Tardive dyskinesia may develop in patients treated with metoclopramide. The elderly, especially elderly women, appear to be at increased risk.
• The risk appears to increase with treatment length and the total amount of drug taken.
• Tardive dyskinesia is more likely to be irreversible with long-term treatment (over 12 weeks).
• Less frequently, tardive dyskinesia can develop with short term treatment at low doses; in these cases, the symptoms are more likely to disappear either partially or completely over time, once treatment has been stopped.
• Tardive dyskinesia may not be easy to recognise in its early stages.
• Metoclopramide treatment beyond 12 weeks should be avoided, unless the benefit is judged to outweigh the risk.

Tardive dyskinesia usually appears as involuntary movements of the tongue, face, mouth or jaw. These movements can include lip smacking, chewing, or puckering, or sticking out of the tongue. Sometimes, movements can include the torso or limbs, such as leg shaking. There are no known treatments for tardive dyskinesia once it has become established.

Health care professionals are reminded that metoclopramide is not authorized in Canada for the following: treatment of hiccups, diabetic gastroparesis (partial paralysis of the stomach), nausea and vomiting in pregnancy, or for symptoms of bloating or constipation associated with eating disorders.

Metoclopramide drugs currently marketed in Canada

Metoclopramide is available in various strengths and forms, including as a solution for injection, or as liquid or tablets that can be taken by mouth. It is sold under generic names only.

List of companies and generic names

Company	Generic Name
Apotex Incorporated	Apo-metoclop tab 10 mg
Apotex Incorporated	Apo-metoclop tab 5 mg
Sandoz Canada Incorporated	Metoclopramide Hydrochloride Injection
Bioniche Pharma (Canada) Ltd.	Metoclopramide Hydrochloride Injection HS
Omega Laboratories Ltd.	Metoclopramide Omega Injection
Pro Doc Limitée	Metoclopramide Tab 10 mg
Pro Doc Limitée	Metoclopramide Tab 5 mg
Nu-Pharm Inc.	Nu-Metoclopramide-Tab 10 mg
Nu-Pharm Inc.	Nu-Metoclopramide-Tab 5 mg
Pharmascience Inc.	PMS-Metoclopramide-Tab 5 mg
Pharmascience Inc.	PMS-Metoclopramide-Tab 10 mg
Pharmascience Inc.	PMS-Metoclopramide-Oral Solution

 

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709