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RECENT CASES |
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GENERAL INFORMATION |
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Bextra Side Effects
and Safety Concerns |
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| Bextra is the brand name
for the prescription drug Valdecoxib, which is
manufactured by Searle, a subsidiary of Pfizer.
Bextra is prescribed to treat arthritis and menstrual
pain. However, Bextra can promote the formation
of blood clots and the constriction of blood vessels,
and has been linked to potentially fatal skin reactions
(Stevens Johnson Syndrome and Toxic Epidermal Necrolysis
(TEN)). |
| Bextra has been linked
to the potentially fatal skin diseases of Stevens
Johnson Syndrome and Toxic Epidermal Necrolysis.
On December 4, 2004, the U.S. Food and Drug
Administration ("FDA") warned that
patients taking Bextra reported serious, potentially
fatal skin reactions. These skin reactions
are most likely to occur in the first two weeks
of treatment but can occur any time during
therapy. In a few cases, these reactions have
resulted in death. |
| The FDA informed doctors
that Bextra should be discontinued at the first
appearance of a skin rash, sores on the inside
of the mouth, or any other sign of allergic
reaction. The new warning also stated that
Bextra contains sulfa, and patients with a
history of allergic reactions to sulfa may
be at a greater risk of skin reactions. |
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SJS
or Toxic Epidermal Necrolysis
is caused by an adverse drug
reaction, resulting in painful
blistering of the skin and mucous
membrane involvement. In many
cases, SJS is preceded by flu-like
symptoms and high fever. As it
evolves the skin literally sloughs
off.
To learn more about SJS, visit the Stevens
Johnson Syndrome Foundation. |
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| On April
7, 2005, at the request of the FDA, Pfizer
Inc. agreed to voluntarily withdraw Bextra
from the market because it increases the risk
of heart attacks and strokes. The FDA furthermore
ordered stronger safety warnings on similar
drugs still on the market. |
| A study reported in November
2004 of 1,500 patients treated after undergoing
coronary artery bypass graft surgery showed greater
cardiovascular risks in patients prescribed Bextra
compared to those receiving a placebo. Among the
dangers observed were myocardial infarction (heart
attack), cerebrovascular accident (stroke), deep
vein thrombosis (blood clots in the leg), and pulmonary
embolism (blood clot in the lung). |
| Patients that have suffered
serious side effects, including heart attacks and
strokes, after having ingested Bextra have filed
personal injury lawsuits and class actions against
Pfizer. The Bextra lawsuits allege that Pfizer
falsely promoted the safety of Bextra and failed
to disclose the full range of the drug's dangerous
side effects. |
| The law in most states
provides several personal injury claims for
persons who have been seriously injured by
a prescription drug with dangerous, undisclosed
side effects. These claims include strict liability
for a defective product, breach of warranty,
negligence, and misrepresentation. Persons
living outside the U.S. who have been injured
by a product manufactured in the U.S. may also
in certain cases file lawsuits for compensation
for injuries in U.S. courts. |
| Damages sought against
manufacturers of an allegedly dangerous prescription
drug typically include: |
- Physical pain and suffering, mental anguish
and physical impairment;
- Medical expenses associated with the
allegedly defective product; and
- Loss of earnings and/or earning capacity.
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