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FDA ALERT-[4/7/2005]: Celebrex has been linked to an increased risk
of serious cardiovascular (CV) events (such as heart attack or
stroke) which appears to be a risk shared by all medicines called
non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin).
FDA has requested that the package insert (labeling) for all NSAIDs,
including Celebrex, be revised to include a “boxed” or serious
warning to highlight the potential increased risk of CV events, and
the well known risk of serious, and potentially life-threatening,
stomach bleeding. FDA has also requested that the package insert for
all NSAIDs be revised to state that patients who have just had heart
surgery should not take these medicines.
What
is Celebrex?
Celebrex is used to:
relieve symptoms of osteoarthritis (the
arthritis caused by
age-related “wear and tear” on bones and joints)
relieve symptoms of rheumatoid arthritis in adults
manage acute pain in adults (like the short term pain you can get
after a dental or surgical operation)
treat painful menstrual cycles reduce the number of colon and rectum
growths (colorectal polyps) in patients with a disease called
Familial Adenomatous Polyposis (FAP). FAP is an inherited disease in
which the rectum and colon are covered with many polyps. Celebrex is
used along with the usual care for FAP patients such as surgery and
exams of the rectum and colon.
Who Should Not Take Celebrex?
Do
not take Celebrex if you:
have had an allergic-type reaction to sulfa medicines.
have had asthma, hives or allergic-type reactions after taking
aspirin or other NSAID (nonsteroidal anti-inflammatory drugs)
medicines. If you have asthma, you may have aspirin-sensitive
asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause
severe narrowing of the airway (bronchospasm), and even death. Since
this type of reaction also has occurred after taking NSAIDs Celebrex
should not be given to aspirin-sensitive patients.
Some examples of NSAIDs are ibuprofen (Motrin, Advil), naproxen (Naprosyn,
Aleve), diclofenac (Voltaren, Cataflam), and ketoprofen (Orudis).
You can ask your doctor or pharmacist for a complete list of these
medications.
are pregnant, especially during your last 3 months
Fluid retention
(holding of water in your body) and swelling. Fluid retention can be
a serious problem if you have high blood pressure or heart failure.
In
addition to the serious side effects listed above, some common, but
less serious side effects with Celebrex may include:
headache, indigestion, upper respiratory tract infection (a "cold"),
diarrhea, sinus inflammation, stomach pain, nausea
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What are The Risks?
Celebrex and other NSAID medicines can cause serious
problems such as:
Stomach ulcers that bleed.
The chance of this serious problem increases the longer you
take Celebrex, but it can also happen suddenly. Stop taking
Celebrex and call your healthcare professional right away if
you get a burning stomach pain, black bowel movements that
look like tar, or vomit that looks like blood or coffee
grounds.
Liver damage.
Some of the warning signs of liver damage are nausea,
vomiting, tiredness, loss of appetite, itching, yellow
coloring of skin or eyes, “flu-like” symptoms and dark
urine. If this happens, stop taking Celebrex and call your
healthcare professional right away.
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Kidney problems
that include sudden kidney failure or worsening of kidney
problems that you already have.
What Should I Tell My Healthcare Professional?
Tell your healthcare professional if you:
have heart problems or high blood pressure
have liver or kidney problems
have or had stomach ulcers or stomach bleeding
have asthma
are allergic to aspirin or other NSAID medicines
are trying to become pregnant, are already pregnant, or are
breast-feeding
Are There Any Interactions With Drugs or Foods?
Tell your healthcare professional about all the medicines you take,
including prescription and non-prescription medicines, vitamins, and
herbal supplements. Some medicines may affect how Celebrex works or
Celebrex may affect how your other medicines work. Your healthcare
professional may have to adjust your dose or watch you closely if
you take any of the following medications:
certain blood pressure medicines called ACE inhibitors
furosemide
fluconazole or ketoconazole
phenytoin
warfarin
aspirin |