Plavix (blood thinner): New recommendations for use with proton pump inhibitors (antacids)

Starting date:

September 22, 2011

Posting date:

September 22, 2011

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Identification number:

RA-110004578

• Media enquiries
• Public enquiries

Health Canada is informing health professionals and patients of updated recommendations involving the use of Plavix in combination with a class of drugs known as proton pump inhibitors (PPIs). New evidence has shown that while PPIs do interact with Plavix, not all reduce the effectiveness of Plavix to the same degree.

Plavix (the brand name for clopidogrel) is a prescription blood thinner used to prevent blood clots that could lead to heart attack or stroke. It is given to patients with a history of heart-related problems, such as heart attack and stroke, to prevent future events. PPIs are prescription antacids used to treat heartburn and stomach ulcers. As heartburn and stomach ulcers can occur as side effects of Plavix, patients taking Plavix may also be given a PPI to prevent or ease their symptoms. See below for a list of Proton Pump Inhibitors sold in Canada.

In 2009, the labelling for Plavix was updated to indicate that the use of any PPI in patients taking Plavix should be discouraged, as emerging data suggested that PPIs potentially reduced the ability of Plavix to protect against blood clots. This label update was communicated in a letter to health professionals and to the public.

Since that time, new studies have shown that, while PPIs do interact with Plavix, not all PPIs interact to the same degree: some have a strong effect on Plavix, while others do not.

The labelling for Plavix has been updated with new recommendations regarding the use of PPIs:

• PPIs known to strongly or moderately reduce Plavix effectiveness should be avoided. Omeprazole is one of these.
• If a PPI must be used in a patient taking Plavix, consider a PPI that does not interact as strongly. Pantoprazole is one of these.

Patients taking Plavix should continue taking it as directed. If you are considering or are already taking a PPI, talk to your health professional regarding any questions or concerns about your treatment. There are alternatives to PPIs for the treatment of stomach ulcers and heartburn.

Drug labels, also known as "Product Monographs," contain important prescribing and safety information for health professionals and patients, and are available by search of Health Canada's Drug Product Database.

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:

• Fax: 1-866-678-6789
• Internet: www.healthcanada.gc.ca/medeffect
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701E
  K1A 0K9

PPI drugs currently marketed in Canada

The following proton pump inhibitors are available in Canada:

• Dexlansoprazole (sold under the brand name Dexilant)
• Esomeprazole (sold under the brand name Nexium and its generic equivalent)
• Omeprazole (sold under the brand name Losec and its generic equivalents)
• Lansoprazole (sold under the brand name Prevacid and its generic equivalents)
• Pantoprazole (sold under the brand names Pantoloc and Panto IV, and their generic equivalent(s))
• Pantoprazole/magnesium (sold under the brand name Tecta)
• Rabeprazole (sold under the brand name Pariet and its generic equivalents)

PPIs are also available in combination with other drugs, for example: Vimovo (contains esomeprazole).

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-57-2991
1-866 225-0709