Bextra
Bextra is a powerful
medication that targets an important source of arthritis pain.
And there's one convenient dose that's powerful enough to tackle
both the pain of osteoarthritis and adult rheumatoid arthritis.
BEXTRA also delivers relief to the pain associated with moderate
to severe menstrual pain (primary dysmenorrhea).
Common uses
This medicine is a nonsteroidal anti-inflammatory
drug (NSAID) known as a COX-2 inhibitor used to relieve the symptoms
of arthritis (osteoarthritis, rheumatoid), and menstrual discomfort.
This drug works by blocking the enzyme in your body that makes
prostaglandins. Decreasing prostaglandins helps to reduce pain
and swelling.
FDA Warnings Regarding Bextra
FDA and Pharmacia are advising health care professionals about
new warnings and information in the product labeling of the drug
Bextra (valdecoxib), a drug approved for treatment of osteoarthritis,
rheumatoid arthritis and dysmenorrhea (menstrual pain). The labeling
is being updated with new warnings following postmarketing reports
of serious adverse effects including life-threatening risks related
to skin reactions -- including Stevens Johnson Syndrome, and anaphylactoid
reactions (serious allergic reactions). In addition, the labeling
will state that the drug is contraindicated -- not to be used
-- in patients allergic to sulfa containing products.
On November 13, 2002, Pharmacia, the manufacturer
of Bextra sent letters to health care professionals advising them
of postmarketing reports and new warnings that will be included
in the drug label. Since the firm began marketing the drug in
March of 2002, cases of the serious skin and hypersensitivity
reactions have been reported. These included cases of Stevens
Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis
and erythema multiforme. Although these adverse events are rare,
some of these patients required hospitalization. Based on these
reports, FDA has approved labeling changes for Bextra that include
a warning for serious skin reactions. As these reactions can be
life threatening, people who start Bextra and experience a rash
should discontinue the drug immediately.
General Precautions with Bextra:
Bextra and other NSAID medications can cause serious problems
such as 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 Bextra and call your doctor
right away.
Bextra can cause fluid retention (holding of
water in your body). Fluid retention can be a serious problem
if you have high blood pressure or heart failure.
Do not use Bextra if you have asthma and are allergic to aspirin.
If an aspirin-sensitive asthmatic takes aspirin it can cause severe
narrowing of the airway (bronchospasm), and even death. The same
reactions to aspirin and other NSAID medicines happened in aspirin-sensitive
patients.
Important Questions Regarding Bextra
What is Bextra used for?
Bextra is used to relieve symptoms of osteoarthritis and rheumatoid
arthritis in adults and painful menstrual cycles
Who should not take Bextra?
You should not take Bextra if you:
• Had asthma, hives or allergic reactions
after taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory
drugs) or COX-2 inhibitors. Some examples of NSAIDs are ibuprofen
(Motrin, Advil), naproxen (Naprosyn, Aleve), diclofenac (Voltaren,
Cataflam), nabumetone (Relafen), ketoprofen (Orudis), celecoxib
(Celebrex), and rofecoxib (Vioxx). You can ask your doctor or
pharmacist for a complete list of these medications
• Are allergic to valdecoxib (Bextra) or
to any of the ingredients in Bextra Special Warnings with Bextra:
Bextra and all NSAID medications can cause stomach
ulcers that bleed. The chance of this serious problem increases
the longer you take Bextra, but it can also happen suddenly. Stop
taking Bextra and call your doctor right away if you get:
• A burning stomach pain
• Black bowel movements that look like tar
• Vomit that looks like blood or coffee grounds
What should I tell my health care provider?
Tell your health care provider 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 pregnant or planning to become pregnant
• Are breast-feeding
Tell your health care provider about all the
medicines that you are taking, including prescription and non-prescription
medicines, vitamins, and herbal supplements. Your health care
provider may have to adjust your dose or watch you more closely
if you take the following medications:
• Certain blood pressure medicines called
ACE inhibitors
• Furosemide (Lasix)
• Fluconazole or ketoconazole
• Lithium
• Warfarin (coumadin)
• Aspirin
What are some possible side effects of Bextra?
(This is NOT a complete list of side effects reported with Bextra.
Your health care provider can discuss with you a more complete
list of side effects.)
Side effects can include:
• Indigestion
• Nausea
• Stomach pain
• Upper respiratory tract infection
• Diarrhea
• Headache
• Rarely serious ulcers and stomach bleeding have occurred
in patients taking Bextra.
For more detailed information about Bextra,
ask your health care provider or pharmacist.
Robert F. Lewis, P.C. has aligned itself with a law firm that
handles mass tort cases. IF YOU OR SOMEONE YOU KNOW HAS TAKEN
BEXTRA, PLEASE CONTACT US. YOU OR THEY MAY HAVE A CASE.
