Advisory

2002-40
May 23, 2002
For immediate release

Important safety information for patients taking CELEBREX^® (celecoxib)

OTTAWA - Health Canada is advising Canadians of new safety information related to the selective COX-2 inhibitor CELEBREX^® (celecoxib), a nonsteroidal anti-inflammatory drug (NSAID). CELEBREX^® is a prescription drug approved for use in Canada for the acute and chronic treatment of osteoarthritis and rheumatoid arthritis in adults.

This advisory is in addition to a letter issued by the manufacturer of CELEBREX^®, following discussions with Health Canada, to health professionals reminding them of the following safety information.

In a large clinical trial, "Celecoxib Long-term Arthritis Safety Study (CLASS)", the gastrointestinal safety of CELEBREX^® (400 mg twice daily) and two other NSAIDs, diclofenac (75 mg twice daily) and ibuprofen (800 mg three times daily), was compared in arthritis patients.

No differences were shown in the risk of ulcer complications (gastrointestinal bleeding, perforation and obstruction) alone among the three treatment groups.

The risk of ulcer complications and symptomatic ulcers (ulcers with abdominal pain, dyspepsia, nausea, diarrhea or vomiting) was shown to be lower for CELEBREX^® than for ibuprofen, but not different from diclofenac.

Results also showed the risk of ulcer complications in patients taking CELEBREX^® and low dose ASA (Aspirin^® or other ASA brands) was 4 times that of patients taking CELEBREX^® alone.

As with all other NSAIDs, patients who experience gastrointestinal symptoms such as abdominal pain and blood in stools while taking CELEBREX^® (with or without ASA) should inform their physician immediately.

All NSAIDs, including CELEBREX^®, should not be used in patients with a history of:

• Active peptic ulcer, active gastric bleeding, active inflammatory disease of the bowel;
• Active liver diseases;
• Severe kidney problems.

As with all other NSAIDs, fluid retention (swelling of the legs) has been observed in some patients taking CELEBREX^® (celecoxib). Patients with a medical history of hypertension (high blood pressure), fluid retention or heart failure are advised to discuss their medical condition with their treating physician before taking CELEBREX^®. Patients who develop fluid retention or swelling, shortness of breath, weakness, fatigue, excessive weight gain or chest pain while on CELEBREX^® therapy should inform their physician immediately.

Patients taking other NSAIDs, including other selective COX-2 inhibitors, are also advised to inform their physician if they experience any of the above symptoms.

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Media Inquiries:
Ryan Baker
Health Canada
(613) 941-8189

Public Inquiries:
(613) 957-2991