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Bextra Class Action Lawsuits Information
Bextra is a prescription medication approved by the FDA in
November 2001 to treat the severe pain associated with osteoarthritis,
rheumatoid arthritis, and primary dysmenorrhea (painful menstrual cramping).
Over 23 million Americans suffer from some form of arthritis. Because there is
no cure for arthritis, pain medications like Bextra are available to treat the
pain associated with this disease. Bextra is manufactured by pharmaceutical
company Pfizer and has come under significant scrutiny since a similar drug was
pulled from the market.
COX-2 selective medicines were developed to treat pain without causing the
significant gastrointestinal side effects that are associated with non-selective
pain medications such as naproxen and ibuprofen. Controversy over the safety of
COX-2 selective pain medications began when a drug similar to Bextra, called
Vioxx (from Merck), was recalled on September 30, 2004 after studies concluded
that taking Vioxx for a period of eighteen months or more doubled a patients
risk of suffering from heart attack or stroke.
Since the Vioxx recall, the cardiovascular safety other COX-2 selective drugs
has come into question. There have been no substantiated reports documented in
medical journals or confirmed by independent researchers that have concluded
that Bextra use poses an increased risk of cardiovascular problems.
Bextra cardiovascular safety was covered in an American Heart Association
meeting in early November 2004. Studies reported at this conference indicated an
increased risk in heart complications for patients taking Bextra who undergo
cardiac bypass surgery. In response to these reports, and the general scrutiny
surrounding COX-2 inhibitors, Pfizer announced in mid October 2004 that plans
are underway to study the long term cardiovascular effects of Bextra.
The FDA and Pfizer are negotiating the inclusion of a black box warning (the
FDA's highest alert category) on all Bextra labeling to disclose information
about the risks of developing serious skin diseases caused by taking Bextra. The
FDA acknowledged twenty cases of serious skin diseases caused by Bextra at the
time of its approval.
Bextra is known to cause a rare but deadly skin disease called Stevens-Johnson
syndrome as well as toxic epidermal necrolysis. Severe allergic reactions
(including anaphylactic shock) have also been associated with Bextra use. Common
side effects of taking Bextra include- but are not limited to- indigestion,
headache, stomach pain, nausea and diarrhea. It is still unclear whether taking
Bextra poses any threat to cardiovascular health.
If you are concerned about the side effects of Bextra or have experienced any
adverse health symptoms, you should speak with a medical professional who can
help. If you have suffered injury as a result of taking Bextra, you may wish to
contact a legal professional who can advise you of your legal rights and options
in a case to recover your damages.
Bextra Side Effects
There are a few serious Bextra side effects that people who
are considering, or currently taking this drug, should be aware of. Bextra is a
COX-2 selective non-steroidal anti inflammatory drug (NSAID). Bextra was
approved by the FDA in November 2001 to treat osteoarthritis, rheumatoid
arthritis and the severe pain associated with menstrual cramping. Even at the
time of Bextra's approval, serious Bextra side effects were already being
reported.
At the time of approval, the FDA acknowledged at least twenty cases of Bextra
side effects that resulted in serious skin problems. Stevens-Johnson syndrome, a
severe inflammatory eruption of the skin and mucous membranes, is one of the
rare but serious Bextra side effects.
Toxic epidermal necrolysis, a syndrome in which large portions of the skin
become red and peels much like a second degree burn, is another of the
potentially serious Bextra side effects. Severe anaphylactic shock and allergic
reaction are also potential Bextra side effects.
The FDA is currently considering the addition of a black box warning, the
agency's strongest alert, on all Bextra labeling warning of serious Bextra side
effects. Bextra's manufacturer, Pfizer, disclosed warnings on product labeling
in 2002 regarding serious skin Bextra side effects. The black box warning would
make information on Bextra side effects more prominent and visible to consumers.
Bextra side effects may also include indigestion, abdominal pain, nausea,
diarrhea, and headache, discolored or bloody stools, unexplained weight gain,
jaundice, flu-like symptoms, unusual bruising or bleeding, and water retention.
If you experience any of these Bextra side effects, you should notify your
doctor immediately.
Bextra side effects have been the topic of significant controversy in late 2004,
after the recall of a similar drug called Vioxx. Merck pulled Vioxx from the
market in September 2004 when studies indicated that patients taking Vioxx had
an increased chance of suffering from a serious heart attack or cerebrovascular
accident (stroke). The cardiovascular safety of all COX-2 selective drugs has
come into question since this recall.
There is talk that Bextra side effects may also include cardiovascular risks.
Pfizer claims that there have been no substantiated reports that indicate heart
attack or stroke as potential Bextra side effects. The drug company has
announced their plans to conduct long term studies of cardiovascular Bextra side
effects.
More Bextra Information
The FDA determined in early April 2005 that the danger of
Bextra was great enough to elicit the recall of this top-selling prescription
pain reliever. On April 7, 2005 Pfizer announced the Bextra recall, stating that
the danger of Bextra side effects greatly outweighed this drug's intended
benefits. Information about the danger of Bextra has been mounting with
exponential speed over the past few months, though the danger of Bextra has been
known for years.
Bextra is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID)
approved by the FDA in November 2001. Bextra, and other prescription COX-2
selective NSAIDs like Vioxx and Celebrex, were developed in the late 1990s to
treat the pain associated with arthritis, menstrual cramps, and other chronic
pain conditions. These drugs were originally designed to effectively treat pain
without causing the gastrointestinal side effects associated with traditional
NSAIDs like naproxen and ibuprofen.
The danger of Bextra use was discovered soon after this drug received FDA
approval. Common side effects of Bextra included gastrointestinal complications
similar to those caused by traditional NSAIDs. Fatal adverse skin reactions were
among the first serious side effects revealing the true danger of Bextra. Bextra
users began to develop a deadly disease known as Stevens Johnson syndrome. This
potentially fatal danger of Bextra attacks the skin and mucous membranes,
essentially burning the skin from the inside out, leading to death if not
promptly and adequately treated.
Once this danger of Bextra became known, the FDA requested that Pfizer add
stronger warnings to Bextra product information. In 2002 the FDA asked Pfizer to
add a black box warning to all Bextra product patient information to inform
patients about the danger of Bextra. A black box is the strongest warning the
FDA can request, short of a drug recall. Despite government pressure, Pfizer
failed to comply with this request and responsibly inform consumers about the
danger of Bextra use.
In 2004 more new about the danger of Bextra was discovered. A Pfizer-sponsored
clinical study was designed to evaluate the effects of Bextra on pain management
after heart surgery. Those participants taking Bextra were twice as likely to
suffer a stroke, heart attack, blood clot, or renal failure as compared to those
in the control group. Despite this added danger of Bextra, Pfizer still
maintained that their product was safe enough to remain on the market.
Strong evidence to the contrary prompted the FDA to ask doctors to prescribe
Bextra only when necessary until the danger of Bextra was further evaluated.
After a few months of investigation, the FDA finally announced that the danger
of Bextra use was too great to allow this defective drug to remain on the
market.
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