Archived – Health Canada Has Asked Pfizer to Suspend Sales of its Drug Bextra and Informs Canadians of New Restrictions on the Use of Celebrex

Starting date:

April 7, 2005

Posting date:

April 7, 2005

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Product withdrawal

Audience:

Healthcare Professionals, General Public

Identification number:

RA-11000533

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Health Canada has asked Pfizer Canada to voluntarily discontinue sales of its drug Bextra™ (valdecoxib) in Canada until safety issues have been resolved. Pfizer has agreed and will be discontinuing sales.

Health Canada has asked the manufacturer to submit evidence to establish the safety of this drug product under the conditions of use for which it is recommended. In addition the manufacturer has been asked to provide Health Canada with a risk/benefit analysis indicating the product's unique therapeutic advantage.

Health Canada's decision is based on an ongoing review of information with regard to serious, potentially life-threatening skin reactions. It is based on Canadian and foreign data, including publicly available information from the United States. Health Canada has already published, on December 10, 2004 a public advisory indicating that serious potentially life threatening skin reactions had been reported in patients taking Bextra™. The prescribing information and patient instructions were modified at that time to reflect the higher incidence of these events.

We encourage people taking Bextra™ to contact their physician to discuss discontinuing use and alternative treatments. After having consulted with a physician, consumers should return the product to their pharmacy. In order to avoid contaminating ground or municipal water systems, the product should not be flushed down the toilet or sink.

In addition to this action on Bextra™ Health Canada is also recommending important new usage restrictions for Celebrex^® (celecoxib), another selective COX-2 inhibitor.

The usage restrictions on Celebrex^® are based on Health Canada's ongoing scientific review of the cardiovascular safety of selective COX-2 inhibitor non-steroidal anti-inflammatory drugs (NSAIDs). Products such as Celebrex^® and Bextra™ work by selectively blocking an enzyme commonly known as COX-2 that is linked to pain, inflammation and fever.

Health Canada's ongoing scientific review started in the fall of 2004, when the long-term use of a similar drug, Vioxx^® (rofecoxib), was linked to an increased risk of heart attack and stroke, and its manufacturer withdrew it from the global market.

New restrictions concerning the use of Celebrex^® are as follows:

• Patients who have had a heart attack or stroke, experienced serious chest pain related to heart disease, or who have had serious diseases of the heart such as congestive heart failure, should NOT use this medication.
• Patients who have significant risk factors for heart attack or stroke should be aware that using this drug may increase this risk. Risk factors for heart attack and stroke include high blood pressure (treated or untreated), high cholesterol, diabetes and smoking. In consultation with their doctors, patients with such risk factors should consider using other types of medications or pain relief therapies.
• This medication should be prescribed and used at the lowest possible dose, and for the shortest, necessary period of time.
• Selective COX-2 inhibitor NSAIDs should only be used to treat the pain and inflammation of arthritis, and certain types of acute pain. These drugs may be used to treat osteoarthritis and rheumatoid arthritis. Celebrex^® may be used for the short-term (one week or less) management of moderate to severe pain in adults caused by conditions such as sprains, surgery or tooth extractions. In the past, Celebrex^® had been used to treat family polyposis (the presence of multiple polyps in the colon) but this indication was cancelled in December, 2004 and a public advisory was issued at that time.

Health Canada scientists continue to review Canadian and international safety data and other sources of information regarding cardiovascular risk and the use of other COX-2 inhibitor NSAIDs. They are also consulting external experts in fields such as cardiology, rheumatology and pharmacology. Health Canada will advise Canadians if other safety concerns arise.

Health Canada urges patients using Celebrex^® to consult their physicians in order to weigh the risks and benefits of these drugs in light of their own medical circumstances.

Previous safety information on selective COX-2 inhibitor NSAIDs was issued on November 19 and December 22, 2004.

1. December 22, 2004: Safety information regarding selective COX-2 inhibitor NSAIDs
2. December 20, 2004: Important safety information on Celebrex^® (for doctors)
3. December 17, 2004: Updated safety information on Celebrex^® (for patients)
4. December 10, 2004: Bextra™ - Cardiovascular risks and serious skin reactions (for doctors)
5. December 10, 2004: Bextra™ - Cardiovascular risks and serious skin reactions (for patients)
6. November 19, 2004: Safety information regarding selective COX-2 inhibitor NSAIDs

Selective COX-2 inhibitor NSAIDs are marketed worldwide. Other regulatory agencies have advised caution in the use of these drugs while they continue to review the available safety evidence. The recommendations made by other regulatory authorities generally concur with those of Health Canada:

• Australia (review complete)
• Europe (interim findings)
  • COX-2 inhibitors
  • Bextra
• New Zealand (interim findings)
• United States

Foreign regulatory agencies have made additional recommendations about selective COX-2 inhibitors such as etoricoxib, lumiracoxib and parecoxib that have not been approved for use in Canada.

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Telephone: 613-957-0337

Facsimile: 613-957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Telephone: 1-866-234-2345

Facsimile: 1-866-678-6789

cadrmp@hc-sc.gc.ca

For other inquiries: please refer to contact information.

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

• Report of Suspected Adverse Reaction due to Health Products Marketed in Canada (Vaccines excluded)
• Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Guidelines for the Voluntary Reporting of Suspected Adverse Reactions to Health Products by Health Professionals and Consumers

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