Advisory
2005-17
April 7, 2005
For immediate release
Health Canada has asked Pfizer to suspend sales of its drug Bextra™ and informs canadians
of new restrictions on the use of Celebrex®
OTTAWA - 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.
- December 22, 2004: Safety information regarding selective COX-2
inhibitor NSAIDs
- December 20, 2004: Important safety
information on Celebrex® (for doctors)
- December 17, 2004: Updated safety information on Celebrex® (for
patients)
- December 10, 2004: Bextra™ - Cardiovascular
risks and serious skin reactions (for doctors)
- December 10, 2004: Bextra™ - Cardiovascular
risks and serious skin reactions (for patients)
- 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.
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
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health
professionals may call toll free:
Tel: 866 234-2345
Fax: 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.
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Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
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