This is a summary of the most important
information about Celebrex. For details, talk to your healthcare
provider.
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
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.
- Kidney problems that include sudden kidney
failure or worsening of kidney problems that you already
have.
- 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
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
Celebrex FDA Approved 1998
Patient Information Sheet Revised 04/2005
Patient Information Sheet - Questions? Call
Drug Information 301-827-4570