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

Starting date:

March 7, 2012

Posting date:

March 7, 2012

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-190001061

This is duplicated text of a letter from Teva Canada Limited and other Canadian manufacturers of domperidone.
Contact the company 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

March 7, 2012

Subject: Association of domperidone maleate 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 new safety information for domperidone.

Domperidone is a medication used to treat symptoms of slowed stomach emptying caused by some stomach and intestine problems (such as gastritis or gastroparesis). Domperidone is also used to prevent symptoms such as nausea and vomiting caused by some drugs used to treat Parkinson's disease.

It is important to be aware of the following information:

• The risk of serious abnormal heart rhythms or sudden death (cardiac arrest) may be higher in patients taking domperidone at doses greater than 30 mg a day, or in patients who are more than 60 years old, based on results from recent studies.
• Domperidone should be used at the lowest possible dose that is right for you, including if you are suffering from Parkinson's disease.
• If you have:
  • a heart condition with abnormal electrical activity of your heart (especially a condition called QT prolongation) or
  • a heart condition such as heart failure or
  • low blood levels of potassium or magnesium,
  domperidone should be used with caution when taken together with other drugs that can change the electrical activity of the heart.

Changes to the electrical activity of your heart (called QT interval prolongation and seen on the electrocardiogram [ECG]) can lead to serious abnormal heart rhythms. These abnormal heart rhythms can be life-threatening.

More detailed information about the recent studies on domperidone and the risk of serious abnormal heart rhythms and sudden death (cardiac arrest) can be found in a related communication for healthcare professionals.

If you experience any symptoms of abnormal heart rhythms such as heart palpitations, dizziness, fainting, or seizures while you are taking domperidone, you should stop taking domperidone and get medical attention right away.

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

If you are already taking domperidone, you should talk to your healthcare professional to find out if you are taking the correct dose for you. Contact your healthcare professional before stopping or changing your dose of domperidone.

Domperidone is also called domperidone maleate, or:

• Apo-domperidone
• Ava-domperidone
• Dom-domperidone
• Jamp-domperidone
• Mylan-domperidone
• Nu-domperidone
• PHL-domperidone
• PMS-domperidone
• Domperidone-10
• RAN-domperidone
• Domperidone
• Teva-domperidone
• Ratio-domperidone

The manufacturers of domperidone products are working with Health Canada to include this new safety information about serious abnormal heart rhythms and sudden death (cardiac arrest), as well as the new dosing information, in the Canadian Product Monographs for domperidone.

These Canadian Product Monographs are reference documents for healthcare professionals prescribing domperidone. They can be found in the Drug Product Database on the Health Canada Web site, or by contacting the manufacturers listed in the box below.

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

• Apotex Incorporated Telephone: 1-800-667-4708 Telefax: 1-416-401-3819
• Avanstra Inc. Telephone: 1-855-708-3678 Telefax: 1-855-227-5833
• Dominion Pharmacal Telephone: 1-888-550-6060 Telefax: 1-514-340-0164
• Jamp Pharma Corporation Telephone: 1-888-399-9091 Telefax: 1-450-449-1546
• Mylan Pharmaceuticals ULC Telephone: 1-800-575-1379 Telefax: 1-304-285-6409
• Nu-Pharm Inc. Telephone: 1-905- 886-2344 Telefax: 1-905-886-0564
• Pharmel Inc. Telephone: 1-888-550-6060 Telefax: 1-514-340-0164
• Pharmascience Inc. Telephone: 1-888-550-6060 Telefax: 1-514-340-0164
• Pro Doc Limitée Telephone: 1-800-575-1379 Telefax: 1-416-236-4363
• 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
• Teva Canada Limited and ratiopharm Inc. 1-800-268-4127 ext 5005 (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 the Canada Vigilance Program by one of the following 3 ways:

• Report online at MedEffect™ Canada
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    Health Canada
    Postal Locator 0701E
    Ottawa, Ontario K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please 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

Mathi Mathivanan, PhD
Director, Regulatory Affairs
Teva Canada Limited