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Bextra was first approved by the Food & Drug Administration (FDA) in
November, 2001. Drug manufacturer Pfizer removed Bextra from the market,
following a FDA request, on April 7, 2005.
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Bextra was removed from the pharmaceutical market due to health risks and
side effects that included greater risk of heart attacks, strokes,
cardiovascular events and gastrointestinal bleeding in patients.
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Each year approx. 100,000 people
die and 2.1 million are seriously injured from adverse drug reactions.
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In 2004 Pfizer recorded
approximately $1.5 billion in Bextra sales.
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It is estimated that 7 million
patients have been prescribed Bextra.
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Approx. 12.9 million
prescriptions were written for Bextra in 2004.
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April 2000: FDA requires Merck to add information about serious side
effects to Vioxx labeling.
November 16, 2001: FDA approves Bextra for treatment of arthritis, acute
pain, and severe menstrual symptoms.
November 13, 2002: FDA and Bextra drug manufacturer (Pharmacia at the
time) release new warnings and product labeling. The labeling is updated
with new warnings following post marketing reports of serious adverse
effects including life-threatening risks related to skin reactions.
July, 2004: FDA adds warning to Bextra label regarding possible
serious skin reactions.
September 30, 2004: Merck recalls NSAID, COX-2 inhibitor Vioxx due to
increased risk of heart attack and strokes in patients.
November, 2004: FDA scientist David Graham testifies before the U.S.
Senate that health concerns regarding Bextra, and other like drugs, are not
new.
"This drug could have been off the market two years ago," Graham said.
December 23, 2004: FDA issues a Public Health Advisory warning of the
"increased risk of serious cardiovascular events", and advising doctors to
limit the use of Bextra, Vioxx and Celebrex for at-risk patients. See the
advisory,
click here.
January 10, 2005: The Department of Health & Human Services sends
drugmaker Pfizer a warning label stating that specific 'Direct to Consumer'
(DTC) marketing for Celebrex and Bextra "omit material facts, including the
indication and risk information; ... make misleading safety, unsubstantiated
superiority, and unsubstantiated effectiveness claims".
Full Warning Letter
January 24, 2005: The nationwide consumer organization Public Citizen
petitions the FDA to remove Bextra and Celebrex from the market because of
their cardiovascular risks. See
Full Petition
February, 2005: FDA Advisory Panel unanimously concluded that Bextra,
Vioxx and Celebrex, all COX-2 inhibitors, significantly raise heart and
stroke risk.
April 7, 2005: Pfizer halts sales of Bextra based on FDA
recommendations. FDA finds that health risks associated with Bextra outweigh
prescription's benefits.
If you are currently taking Bextra,
you should immediately contact your doctor to discuss alternative
medication. Any decision about which drug product to take to treat your
symptoms should be made in consultation with your physician based on an
assessment of your specific treatment needs.
If you have been injured by Bextra
the manufacturer may have failed in its duty to design, make, inspect and
label the product appropriately.
Brown & Crouppen has been building a reputation for success with
personal injury clients for almost 25 years. Today, we are one of
mid-America’s largest personal injury law firms with over 70 legal
professionals and five offices throughout Missouri and Illinois. Brown &
Crouppen has thrived because of our shared commitment to deliver the best
possible service to clients throughout Missouri and the United States. A
large area of our concentration is dangerous drug litigation involving
manufacturers and suppliers of unsafe drugs and products.
Contact our experienced injury attorneys today for a
FREE claim evaluation. Contact Us Online, or call:
1(800)536-HELP | |
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