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
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
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
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.
SIDE EFFECTS of
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:
unexplained weight gain,
swelling of the hands or feet,
change in amount of urine,
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,
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