Other Scary Information About Bextra
Cost Of Bextra
Bextra Causes Death
More On Bextra-Caused Death
FDA Warnings On
Bextra
"I wouldn't Trust Bextra As Far As I Could Throw
It
Source
|
Bextra (valdecoxib)
What is it?
Bextra is a nonsteroidal
anti-inflammatory drug (NSAID) used to reduce pain and inflammation and to
ease mild to moderate pain in osteoarthritis, rheumatoid arthritis and
menstrual pain.
FDA approved:
November 19, 2001
Average annual cost:
About
$900.00
Brand Names and
International Availability:
Bextra (US)
How does it work?
This drug works by
blocking the enzyme in your body that makes prostaglandins. Decreasing
prostaglandins helps to reduce pain and swelling. It does not inhibit
cyclooxygenase-1, which supposedly makes it easier on the stomach than
traditional NSAIDs.
Dosage:
One 10mg or 20mg tablet
daily.
How should I take it?
Take at the same time
every day. May be taken with or without food. If stomach upset occurs take
with food or milk.
Contraindications:
Do not take Bextra if you
have had an allergic reaction to aspirin or other NSAID.
Bextra should be avoided
in those with a history of peptic ulcer or GI bleeding.
The effects of Bextra
have not been studied in children.
It should NOT be used in
the third trimester of pregnancy.
It is not known if Bextra
is excreted in breast milk. It should not be taken by nursing mothers.
Drug Interactions:
Bextra can increase the
effect of anti-coagulants.
Bextra should not be
taken with any other NSAIDs.
Possible side effects:
These side effects are
not considered serious but are certainly annoying for those experiencing
them. The most frequently reported side effects are stomach
upset, nausea, diarrhea, or headache
More serious side effects
that you should report right away include blood in urine, black, tarry
stools, dark yellow or brown urine, difficulty breathing, fast heartbeat,
skin rash, hives, redness, blistering, peeling or itching, stomach
tenderness, pain, bleeding, or cramps, unexplained weight gain or edema, and
yellowing of eyes or skin.
Signs of a possible
allergic reaction are rash, swelling and difficulty breathing. These
symptoms should be reported immediately.
Precautions & Special
Notes:
You may be required to
have frequent blood work while on this medication. It is very important that
you keep all lab and doctor’s appointments.
If you get black, tarry
stools or vomit up what looks like coffee grounds, call your doctor at once.
You may have a bleeding ulcer.
For more information:
Bextra.com
Bextra-Drugstore.com
http://www.hopkins-arthritis.som.jhmi.edu/news-archive/
2001/bextra_fda.html
References:
Bextra.com
Drugstore.com |
Source
| Bextra |
|
Bextra attracts the spotlight for blatant
commercial use of academic journals. |
| |
Like the other COX-2
Inhibitors Vioxx and Celebrex, Bextra (valdecoxib) is
prone to major side effects. |
Update: January 2, 2003 |
Much of the concern over the COX-2 inhibitor valdecoxib
arises not from clinical trials leading to its recent approval by FDA.
Rather, spontaneous adverse event reports have come to the attention of the
European counterpart of FDA, the
European Agency for
the Evaluation of Medicines (EMEA)
concerning
a different drug, parecoxib (Dynastat, Rayzon, Xapit).
Valdecoxib is the active metabolite of parecoxib,
and so is considered highly likely to cause the same effects.
EMEA declares
a "positive opinion" of valdecoxib, but this drug is not yet approved for
marketing by EMEA.
Parecoxib was scrutinized
since its approval March 22, 2002, but adverse events reported for valdecoxib
motivated major revisions October 22, 2002: EMEA issued strong
warnings
to the public and
revised
the label of parecoxib. Interestingly, parecoxib was approved by EMEA for
a much more limited use than FDA approved for valdecoxib, namely acute pain
resulting from surgery.
Much of the anaphylactic reaction resembles that which
occurs in some patients to Penicillin and
related Antibiotics;
Painkillers / Analgesics; and
Arava..
Minor eruption of the skin is localized and transient.
Major eruption of the skin involving mucous secretions can be
life-threatening.
Pharmacia is sued over promotion of off-label use of
pain-killer Bextra
A consumer group has sued Pharmacia (Pfizer) for
illegal Off-Label promotion of the COX-2
inhibitor Bextra (valdecoxib). Pharmacia hired the clinical testing
group Scirex to study the use of Bextra in acute pain associated with
impacted molars; the results were
published in the Journal of the American Dental Association for which
continuing medical education (CME) credit was available.
Public Citizen criticized the use of refereed, academic journals for
commercial promotion of off-label use. Di91
Daniels SE et al., The analgesic efficacy of valdecoxib
vs. oxycodone/acetaminophen after oral surgery. J Am Dent Assoc. 2002
May;133(5):611-21; quiz 625.
Opinion: The manipulation of academic, peer-reviewed medical research
journals is one of the greatest flaws in American medicine. Physicians and
medical research scientists and their organizations (medical schools,
societies such as the American Medical Association (AMA) have
allowed themselves to become dependent on this source of financial support
and as a result objectivity is compromised. In legal terms, the fact of
this relationship makes the Daubert criteria for admission of
evidence strongly favorable to the interests of the pharmaceutical
industry. The Daniels et al. publication is unusual in that the conflict of
interest is very obvious, whereas most of the influences of this type are
(intentionally or inadvertently) subtle.
See also
COX-2 Experts; see also
COX-2 Inhibitors deflate further; see also
Vioxx.
Source
|
Among the
most feared complications of drug therapy are the exfoliative skin
disorders--erythema multiforme (EM), Stevens-Johnson syndrome (SJS) and
toxic epidermal necrolysis (TEN). Both diseases, SJS and TEN, are primarily,
if not solely, caused by drugs among adults, and approximately 50% are
drug-related among all ages.
The most common drugs associated with SJS and TEN are
antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs) and anti-convulsants.
Prescription NSAIDs, such as Bextra (valdecoxib) and Daypro (oxaprozin),
are one of the leading classes of drugs that cause SJS and TEN reactions.
In many countries, increasing rates of skin eruptions are attributed
to (NSAIDs). NSAIDs have played in increasing role in the etiology or cause
of TEN, and it has been reported in the medical literature that some NSAIDs
that have a long half-life carry a higher risk of SJS or TEN.
History
In 1922,
Stevens and Johnson described two children with fever and stomatitis (mouth
ulcers), severe disseminated conjunctivitis (eye inflammation) and cutaneous
(skin) eruptions. It soon became evident that severe forms of
Stevens-Johnson Syndrome (SJS) could lead to toxic epidermal necrolysis
(TEN) and that both diseases could be induced by the same drugs.
Timing of SJS/TEN reaction
The
reaction usually develops within 1-4 weeks from the onset of starting drug
therapy. However, the prodromal or beginning symptoms can develop within
hours or days and include mild rash, or mucosal lesions or fever of an
unexplained origin. Mucosal lesions include lesions of the mouth, eyes, GI
and respiratory tract, anus and vagina. If any of these symptoms occur, the
drug should be discontinued immediately and you should seek medical
attention. This is because, in some cases, such reactions may develop into
severe, sometimes, life-threatening skin and mucous membrane reactions, such
as SJS and TEN.
Erythema Multiforme / Stevens Johnson Syndrome and Toxic Epidermal
Necrolysis
Most
experts agree that erythema multiforme, a mild blistering skin eruption, is
a milder version of SJS, which can progress into SJS or TEN. The most
severe skin reactions to drug therapy are SJS and TEN, which are skin
diseases that result in eruptions resembling burns and are characterized by
epidermal loss. SJS and TEN are often heralded by fever, sore throat,
cough, and burning eyes for 1 to 3 days. The skin eruption usually begins
as a rash that develops into blisters and mucous membrane involvement,
including the eyes, mouth, respiratory and GI tract, genitals and anus.
Almost 90% of all TEN reactions involve the mucous membrane and 85% have
conjunctivitis or eye lesions.
Mortality and epidemiology (death rate/incidence rate)
Mortality
rates have been reported to be between 25% and 80%. Age and extent of skin
loss are the most significant predictors of mortality. One of the most
frequent causes of death is sepsis or a systemic infection caused by losing
the protection of your skin. Females appear to be about twice as frequently
affected than males with TEN. However, the incidence rate among women
taking certain NSAIDs, such as Daypro/oxaprozin is much higher. There have
been reported annual incidence rates of SJS in the range of 2.6-8.2 per
million reported from a study conducted in the U.S. A higher rate of EM has
been reported to be between 10.2- 46.5 per million from the same study.
RECENT
LAWSUIT SETTLEMENT WITH PHARMACIA, MAKER OF BEXTRA |
Source
FDA Warnings On Bextra
|
Bextra® |
| Brand Name: |
Bextra® |
| Active Ingredient: |
valdecoxib |
| Strength(s): |
10 mg and 20 mg |
| Dosage Form(s): |
Tablets |
| Company Name: |
G.D. Searle & Co. |
| Availability: |
Prescription only |
| *Date Approved by FDA: |
November 16, 2001 |
| *Approval by the FDA does not mean
that the drug is available for consumers at this time. |
| What is Bextra used for?
Bextra is used to relieve:
- symptoms of osteoarthritis and rheumatoid arthritis in
adults
- 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
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.
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.
Link to Bextra's Approved Label
Back to Entry Page
Posted: 11/22/02 |
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Drug Name: bextra
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Source
New Arthritis Drug Approved But Beware
The US Food and Drug Administration (FDA) has approved a
new drug for treating osteoarthritis.
Pharmacia Corp. makes the drug,
Bextra (valdecoxib), while drug giant
Pfizer Inc. is helping to promote it. Bextra is a member of a class of
anti-inflammatory drugs known as COX-2 inhibitors, which work by blocking an
enzyme called cyclooxygenase 2. These drugs are believed to sidestep the
stomach-irritating effects of other nonsteroidal anti-inflammatory drugs
(NSAIDs), such as aspirin.
Osteoarthritis is a progressive deterioration in the
cartilage of certain joints. Unlike rheumatoid arthritis, which is an inherited
autoimmune disease, osteoarthritis results from overuse of joints, and can be a
byproduct of strenuous sports, obesity or aging.
Pharmacia said the drug would also be indicated for
treating rheumatoid arthritis and menstrual pain.
Approval of Bextra, Pharmacia and Pfizer said, was based
upon global clinical trials involving more than 5,000 patients. The companies
said the trials showed that a 10-milligram tablet of Bextra taken once daily was
as effective for treating osteoarthritis as the commonly prescribed doses of
other NSAIDs, including ibuprofen and naproxen.
Reuters Washington
November 19, 2001
DR. MERCOLA'S COMMENT:
From the makers of Celebrex (Pharmacia/Pfizer) we now
have Bextra. I wouldn't trust this company as far as I could throw them.
They have an incredible history of anti-consumerism.
Pharmacia Corporation was
created in April 2000 through the merger of Pharmacia & Upjohn with
Monsanto Company
and its G.D. Searle unit. Pharmacia employs 59,000 people worldwide and has
research, manufacturing and administrative sales operations in more than 60
countries.
So Pharmacia owns Monsanto. And what does Monsanto do
or make?
Monsanto has a huge
history of suppressing
information.
They did it for Celebrex and created a major
controversy earlier this year when JAMA published an article that strongly
promoted Celebrex and helped push it to one of the most popular drugs in the
world.
The only problem is that the
JAMA article was
based on a pack of lies.
I may prescribe the drug in the future, but I would not
for one minute believe one word of what Pharmacia says about it. They have a
large history of deceptive practices and I would not be surprised in the least
if in a few years we find out the truth behind this drug.
The market for analgesics is about
TEN BILLION dollars per year. That is one
big number. That is why this is an important drug to watch. It is important to
remember that anytime you are dealing with numbers that large there will
inevitably be corruption, greed and negative influences that are a part of the
story if drugs are involved.
So ALWAYS be alert to deception. As one of my friends,
Dr. Tom Stone, is fond of saying "The PLANET is RULED by GREED and DECEIT!"
Dr. Jay Cohen, an associate professor of Family and
Preventative Medicine and of Psychiatry at the University of California in San
Diego and author of
Over Dose also writes:
"In addition, for arthritis, Bextra is 1-size-fits-all, which means young and
old, big and small, sick and well, or people on no drugs or on 6 drugs, will all
get the same dosage -- 10 mg.
"This is downright stupid and against all medical science. But it makes it easy
for doctors so they can move on to the next patient much quicker. That's why
these types of drugs sell well. I has nothing to do with sound science or the
welfare of patients."
You can reach Karl Loren at www.PainStudy.com by mail at 1831 N. Bel Aire Drive, Burbank, CA 91504.
Within the US and Canada, use the toll free number: (800) 523-4521, the local number: (818) 558-1799, the FAX: (818) 558-7299, eMail to karl@painstudy.com
Copyright © May 20, 2008 6:26 AM by Karl Loren on behalf of Vibrant Life, ALL RIGHTS RESERVED.
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