Bextra
Lawsuit The pharmaceutical company Pfizer
has been asked by the FDA to remove Bextra from the marketplace. Bextra
is prescribed for patients with arthritis, in need of pain management or who experience
severe menstrual symptoms. Bextra is a nonsteroidal anti-inflammatory drug (NSAID). The
FDA has said the health risks of Bextra far outweigh the benefits due to an increased
risk of cardiovascular (CV) events with long-term use. This is bolstered by the
significant rise in CV risk seen in patients who had recently undergone heart
surgery. FDA granted Bextra approval in November 2001 and
nearly 7 million patients worldwide have taken Bextra, with 12.9 million prescriptions
written in the past year. Recent s tudies show an increased
risk of heart attacks, strokes and other cardiovascular events in patients taking
Bextra. In addition, the FDA cites an increased risk for gastrointestinal bleeding
and life threatening skin reactions, including Stevens Johnson Syndrome (SJS). All
patients who have taken Bextra and suffered any of these side effects may be due
compensation from the manufacturer. Anyone falling into this category, you should
contact a lawyer right away to learn about their legal rights.
Bextra
News DOCTORS SAY AVOID PFIZER'S BEXTRA -MEDICAL JOURNAL
Reuters
December 17, 2004
by Kim Dixon CHICAGO
(Reuters) - Doctors writing in a prominent medical journal on Friday recommended
that physicians stop prescribing Pfizer Inc.'s Bextra painkiller, just as a large
study found the drugmaker's sister drug, Celebrex, doubled risk of heart attacks. Both
drugs are members of the so-called COX-2 inhibitor class of painkillers, which
recently gained notoriety when Merck Inc. withdrew Vioxx in September after a
study found it doubled the risk of heart attack and stroke. A
letter by doctors published in The New England Journal of Medicine's Dec. 23 edition
said in light of Vioxx and negative signs on Bextra, Bextra should be avoided. "To
protect the safety of the public, we write to recommend that clinicians stop prescribing
valdecoxib (Bextra), except in extraordinary circumstances," editorial writers
at The New England Journal of Medicine wrote in an issue dated Dec. 23 but released
early. Earlier on Friday, Pfizer said a government-sponsored
trial of Celebrex was halted after patients taking the medicine had more than
twice as many heart attacks as patients taking a placebo. Pfizer
has aggressively defended Bextra and Celebrex since Vioxx's withdrawal and questions
about safety arose. Officials at Pfizer said they had not seen the medical journal
letter and could not comment. Friday's developments will
rekindle debate over the merits and safety of the entire class of painkiller drugs,
doctors said. The authors of The New England Journal of
Medicine letter are doctors at the Vanderbilt University School of Medicine. They
said they made the recommendation in light of the long lag time between when evidence
emerged on Vioxx and its withdrawal, coupled with two negative studies suggesting
Bextra boosts heart problems in bypass patients by a factor of three.
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