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An FDA ordered Bextra recall on April 7, 2005 was issued by Pfizer
due to significant concerns about the safety of their top-selling painkiller. This Bextra
recall has been at the forefront of social awareness since the Vioxx recall in September
2004.
Bextra (valdecoxib) is in a class of drugs called nonsteroidal anti-inflammatory
drugs (NSAIDs).The Bextra tablet works by reducing substances that cause inflammation,
pain, fever and stiffness caused by osteoarthritis and adult rheumatoid arthritis. It is
also used to treat painful menstruation and some other medical conditions.
Bextra side effects include increased heart attack, stroke risks and rare skin
diseases such as Stevens Johnson Syndrome and Toxic Epidermal Necrolysis. Bextra is in
the same class of drugs as Vioxx and Celebrex. Vioxx was withdrawn after studies showed
it was too dangerous. These drugs are Cox 2 Inhibitors; a drug class that many researchers
believe interferes with the body's natural ability to reduce blood clots, thereby increasing
heart risks. Immediately after the Vioxx recall, the cardiovascular safety of all COX-2
NSAIDs came into question as experts and consumers began to anticipate a Bextra recall.
Expectations of a Bextra recall grew after studies indicated cardiovascular risks
for patients taking Bextra. Bextra side effects of trial participants treated with Bextra
were two times more likely to suffer a heart attack, blood clot, stroke, or other adverse
cardiovascular event than participants in the control group and resulted in the Bextra
recall being issued. After the release of the Bextra side effects information, consumers
and experts began to urge Pfizer to issue a Bextra recall. Pfizer maintained the use of
Bextra was safe and that the results of this clinical trial did not sufficiently warrant
a Bextra recall.
The chance of Bextra side effects occurring increases the longer you take Bextra,
but they can also happen suddenly. Stop taking the Bextra tablet 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. 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.
The Bextra recall was ordered by the FDA after regulators concluded that
potentially fatal risks associated with Bextra side effects far outweigh its benefits.
The FDA singled out this NSAID for a Bextra recall because it gives no added benefits as
a painkiller and is also associated with a serious and deadly skin condition called
Stevens Johnson syndrome. Prior to the Bextra recall, Stevens Johnson syndrome claimed
the lives of some Bextra users. The FDA requested that stronger Bextra side effects
warnings be added to Bextra labeling. Pfizer declined to cooperate with this FDA request
for more than two years prior to the Bextra recall.
People who have been injured by Bextra side effects prior to the Bextra recall
have the legal right to seek compensation for their losses through a Bextra lawsuit. If
you are interested in learning more about the Bextra recall, please contact a knowledgeable
and experienced Bextra lawyer to determine your legal rights and options.
The Bextra recall comes after months of congressional testimony about the efficacy
of the FDA and its ability to protect the public from dangerous drugs in the wake of the
Vioxx withdrawal.
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