Information Update/Metoclopramide: Stronger Warnings on Risk of Abnormal Muscle Movements
(firmenpresse) - OTTAWA, ONTARIO -- (Marketwire) -- 07/20/11 -- 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 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 authorised 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.
How to report side effects to health products
To report suspected side effects to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form () and send to us using one of these methods:
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.
Egalement disponible en francais
Contacts:
Media Inquiries:
Health Canada
613-957-2983
Public Inquiries:
613-957-2991
1-866-225-0709
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Datum: 20.07.2011 - 14:18 Uhr
Sprache: Deutsch
News-ID 36344
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contact information:
Town:
OTTAWA, ONTARIO
Kategorie:
Government & Administration
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"Information Update/Metoclopramide: Stronger Warnings on Risk of Abnormal Muscle Movements"
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