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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.

Data source: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2002/2002_40-eng.php

Celebrex Lawsuit

Canada Lawyers Represent Canadians Injured by Celebrex

Celebrex is a popular arthritis drug belonging to the COX-2 family of pharmaceuticals. A recent clinical study indicated that Celebrex may be linked to higher incidences of life-threatening cardiovascular problems, including heart attack and stroke. A competing drug, Vioxx, already has been withdrawn from the market after numerous clinical studies found similar problems.

Celebrex Side Effects

In the study conducted by the National Cancer Institute, patients taking Celebrex suffered more than twice as many heart attacks and strokes as those taking a placebo. Those taking a 400mg daily dosage had a 2.5 times greater risk. Patients taking 800mg were 3.4 times more likely to suffer a serious cardiovascular problem.

In spite of strong evidence that Celebrex may be linked to life-threatening problems, Pfizer announced they would not recall the drug. The company contends that the results of this study are not consistent with earlier clinical studies and therefore a recall is not necessary.

Merck, the manufacturer of Vioxx, came under heated criticism for failing to withdraw the drug after becoming aware of serious problems. Merck also disregarded and discredited clinical studies that indicated an elevated risk of heart attack and stroke.

Data source: http://www.celebrex-lawsuit.ca/

SIDE EFFECTS of Celebrex:

Stomach upset or gas may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur:

severe headache,

unexplained weight gain,

swelling of the hands or feet,

change in amount of urine,

difficult/painful swallowing.

This drug may rarely cause serious liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking celecoxib and consult your doctor or pharmacist immediately:

yellowing eyes or skin,

dark urine,

persistent stomach/abdominal pain,

unusual fatigue.

In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Data source: http://www.pharmacy-online.ca/drugs/celebrex.jsp