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BEXTRA ALERT!
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Pfizer Withdraws Bextra from Market
07/04/2005
Citing concerns regarding the risk of heart attacks, strokes,
"life threatening" skin reactions, and other
cardiovascular events the FDA requested that drugmaker Pfizer
withdraw Bextra from U.S. pharmaceutical markets.
Pfizer says it disagrees with regulators, but will withdraw
Bextra and re-label Celebrex following concerns about risks of
COX-2 drugs.
"Today's actions protect and advance the health of the
millions of Americans who rely on these drugs every day,"
said Dr. Steven K. Galson, acting director of FDA's Center for
Drug Evaluation and Research.
The risks posed by Bextra outweigh its benefits, the FDA said.
The FDA has been studying the safety of the so-called Cox-2
inhibitors since Merck & Co. voluntarily pulled Vioxx from
the market Sept. 30 after heart problems were reported in some
users. Once blockbuster sellers, the painkillers were
particularly popular among arthritis sufferers.
"For now, patients should stop taking Bextra and contact
their physicians about appropriate treatment options,"
Pfizer said in a statement Thursday.
If you, or a loved one, has taken Bextra and suffered any side
effects, the MEDLAW Legal Team can help protect your rights.
Contact us online for a Free Claim
Evaluation.
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Bextra (valdecoxib) is in
a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).
Valdecoxib works by reducing substances in the body that cause
inflammation, pain, and fever, and is used to reduce pain, inflammation,
and stiffness caused by osteoarthritis and adult rheumatoid arthritis.
Bextra’s label already warns against serious skin reactions as a
possible side effect, and some trials found an increased risk of
unspecified “cardiovascular events” in Bextra patients who had
cardiac bypass surgery.
The
American
Heart Association (November 9, 2004), reported
that a preliminary study demonstrated that the incidence of heart
attacks and strokes among patients given Pfizer's painkiller Bextra was
more than double that of those given placebos. Further studies are
planned.
A U.S. Food and Drug Administration employee who
has criticized his agency's handling of Vioxx said the agency also needs
to look at safety questions about a handful of other drugs, including
Pfizer Inc.'s (PFE) Bextra, a drug that is similar to Vioxx.
Doctors said it is too early to quantify the potential risk of Bextra or
of Pfizer's other COX-2 inhibitor Celebrex as neither have tested for
long enough. Pfizer said it is conducting longer term trials in
arthritis patients.
Pfizer's research studied use
of Dynastat and Bextra in patients who had just had coronary artery
bypass graft. In
these studies, there was an increase in cardiovascular events.
Some of the more
serious, possible side effects of Bextra include:
- Cardiovascular / Heart
problems including strokes and heart attacks.
- Stevens-Johnson Syndrome
- Abdominal pain,
tenderness, or discomfort
- Bloody, black, or tarry
stools
- Nausea or heartburn
- Bloody vomit
- Unexplained weight gain
- Swelling or water
retention
- Unusual fatigue or
lethargy
- Yellowing of the skin or
eyes
- Flu-like symptoms
- Unusual bruising or
bleeding
Pfizer also said it is updating its label on
Bextra to strengthen a warning about a rare but serious skin reaction,
Stevens-Johnson syndrome, that can occur mainly within the first two
weeks of therapy.
BEXTRA QUESTIONS & ANSWERS
What is Bextra used for?
Bextra (valdecoxib) is in a class of drugs called nonsteroidal
anti-inflammatory drugs (NSAIDs). Valdecoxib works by reducing
substances in the body that cause inflammation, pain, and fever, and is
used to reduce pain, inflammation, and stiffness caused by
osteoarthritis and adult rheumatoid arthritis. Valdecoxib is also used
to treat painful menstruation.
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.
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 should I do if I am currently taking
Bextra?
Contact your doctor to discuss discontinuing use of Bextra and possible
alternative medications. If you have experienced any side effects,
contact a lawyer to review your case. We understand your medical
concerns take priority, but don't ignore your legal right to
compensation.
Your state's law may limit your time to bring a legal claim. To protect
your rights, you need to have your personal injury claim evaluated
immediately.
If you, or a loved one, has taken
Bextra and suffered any side effects, the MEDLAW Legal Team can help
protect your rights.
Our in-house legal team consists of a physician, five
registered nurses, 13 attorneys, and more than 30 staff-members.
As one of the nation's premier pharmaceutical liability law firms, we
represent consumers nationwide who have been victimized by
defective pharmaceutical drugs, including Bextra.
We have the experience to protect your
legal rights and to help you obtain the compensation you deserve.
If you or a loved one have suffered serious side effects from the use of
Bextra, please contact
us for an immediate case evaluation.
Many law firms that advertise aggressively on the Internet are actually
client brokers who refer virtually all clients to lawyers in other firms
and other cities who do the actual work of representing the client.
Janet, Jenner & Suggs, LLC, is a traditional law firm that actively
represents all of our clients. Robert
K. Jenner and Kenneth
Suggs, leaders of the pharmaceutical department within the firm,
will always be accessible to you. Mr. Jenner and Mr. Suggs, nationally
recognized advocates on behalf of victims of defective pharmaceutical
products, and their highly experienced team, will always be ready to
answer your questions.
If you have suffered an
injury, illness, or pain and suffering because of
Bextra, we can assist you in determining if you are
entitled to receive compensation for the harm caused
to you. Time is of the essence. Litigation may be
the only way to receive the damages to which you may
be entitled. Such damages will likely include
lost wages, medical bills, and/or financial
compensation to heirs (in the case of a wrongful
death). Our MedLaw Legal Team of experienced
pharmaceutical attorneys, nurse lawyers, on-staff
physician, and certified nurse paralegals will
review your situation and inform you promptly as to
whether we can assist you in making a claim.
Please
contact us today for a
FREE legal evaluation: 1-888-4-MEDLAW
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