Domperidone Maleate - Association with Serious Abnormal Heart Rhythms and Sudden Death (Cardiac Arrest) - For the Public

Starting date:
January 20, 2015
Posting date:
January 20, 2015
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-43449

This is duplicated text of a letter from Apotex Incorporated, Dominion Pharmacal, Jamp Pharma Corporation, Marcan Pharmaceuticals Inc., Mylan Pharmaceuticals ULC, Pharmascience Inc., Pro Doc Limitée, Ranbaxy Pharmaceuticals Inc., Sanis Health Inc., Sivem Pharmaceuticals ULC and Teva Canada Limited and ratiopharm Inc. Contact the companies for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on domperidone maleate

January 20, 2015

Subject: Domperidone maleate associated with serious abnormal heart rhythms and sudden death (cardiac arrest)

The manufacturers of domperidone in collaboration with Health Canada would like to inform you of additional safety information for domperidone concerning a small increased risk of abnormal heart rhythms and sudden death (cardiac arrest).

Domperidone is a medication used to treat symptoms of slowed stomach emptying and stomach inflammation. Domperidone is also used to prevent symptoms such as nausea and vomiting caused by some drugs used to treat Parkinson's disease.

This safety information is for patients taking domperidone for any condition. It is important for you to be aware of the following information:

  • Some patients taking domperidone may have a small increased risk of serious abnormal heart rhythms or sudden cardiac arrest if they:
    • use doses higher than 30 mg a day;
    • are older than 60 years of age;
    • have certain conditions or take other drugs that may change the electrical activity of the heart (QT prolongation).
  • You should not use domperidone if you:
    • have a known condition with abnormal electrical activity of your heart (called QT prolongation);
    • have low blood levels of potassium or magnesium;
    • have heart disease such as heart failure;
    • have moderate or severe liver disease;
    • take other drugs that may change the electrical activity of the heart or increase the amount of domperidone in your blood.
  • If you experience any symptoms of abnormal heart rhythms such as heart palpitations, dizziness, fainting, or seizures while taking domperidone, you should stop taking domperidone and get immediate medical attention.

Changes to the electrical activity of the heart called QT prolongation can cause abnormal heart rhythms. These can be serious or life-threatening.

Domperidone should be used at the lowest effective dose for the shortest time possible. The maximum recommended dose is 30 mg a day (one 10 mg tablet three times a day). If you are already taking domperidone, contact your health care professional to find out if you are taking the correct dose for you.

Before starting treatment with domperidone, tell your doctor if you have or had any heart problems, low blood levels of potassium or magnesium, liver disease or if you are taking other medications, including medications without a prescription or natural health products.

Domperidone is also called domperidone maleate or:

  • Apo-domperidone
  • Domperidone-10
  • DOM-DOMPERIDONE
  • RAN-domperidone
  • Jamp-domperidone
  • Domperidone
  • Mar-domperidone
  • Ratio-domperidone
  • Mylan-domperidone
  • Teva-domperidone
  • PMS-DOMPERIDONE

The manufacturers of all domperidone products are changing the prescribing information (called Product Monograph) for domperidone to include this safety information about serious abnormal heart rhythms and sudden cardiac arrest.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious abnormal heart rhythms or sudden cardiac arrest, or other serious or unexpected side effects in patients receiving domperidone should be reported to the manufacturer (see the attached list) or Health Canada.

  • Apotex Incorporated Telephone: 1-800-667-4708 Telefax: 1-416-401-3819
  • Dominion Pharmacal Telephone: 1-888-550-6060 Telefax: 1-514-340-0164
  • Jamp Pharma Corporation Telephone: 1-866-399-9091 Telefax: 1-450-449-4326
  • Marcan Pharmaceuticals Inc. Telephone: (613) 228-2600 ext. 229; Fax: (613) 224-0444
  • Mylan Pharmaceuticals ULC Telephone: 1-800-575-1379 Telefax: 1-304-285-6409
  • Pharmascience Inc. Telephone: 1-888-550-6060 Telefax : 1-514-340-0164
  • Pro Doc Limitée Telephone: 1-800-361-8559 Telefax: 1-450-668-3585 or 1-888-977-6362
  • Ranbaxy Pharmaceuticals Inc. Telephone: 1-866-840-1340 Telefax: 1-905-602-4216
  • Sanis Health Inc. Telephone: 1-866-236-4076 Telefax: 1-905-689-1465
  • Sivem Pharmaceuticals ULC Telephone: 514-832-1286 Telefax: 514-832-1161
  • Teva Canada Limited and ratiopharm Inc. 1-800-268-4127 ext 1255005 (English), 1-877-777-9117 (French), Telefax: 1-416-335-4472

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

For other health product inquiries related to this communication, contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Yours sincerely,

original signed by:

Colin D'Cunha, MBBS, MHSc, FRCPC
Director, Global Medical Affairs,
Apotex Inc.

Len Neirinck, Ph.D.
Vice-President and Chief Scientific Officer,
Scientific Affairs,
Pharmascience Inc. and Dominion Pharmacal Inc.

Nathalie Toutant
Vice-president, Scientific Affairs
Jamp Pharma Corporation

Sudheer Paladugu, M.Pharm
Vice President - Technical
Marcan Pharmaceuticals Inc.,

Joanne Manley
Director Regulatory Affairs
Mylan Pharmaceuticals ULC

Jovette Deschênes
Director,
QC/QA, Regulatory Affairs
Pro Doc Limitée

Sukhvir Hundal
Director Regulatory Affairs
Ranbaxy Pharmaceuticals Canada Inc.

Paul Bonnici
Director Regulatory Affairs/QA
Sanis Health Inc

Fraidianie Sévigné
Director, Regulatory Affairs and Quality
Sivem Pharmaceuticals ULC

Bruce Valliant
Director, Medical Affairs
Teva Canada Limited