About Pfizer
Pfizer, one of the largest pharmaceutical companies in the world, has enjoyed an annual revenue of almost three billion dollars from Celebrex sales in the US since this prescription painkiller was d its ads for the pain reliever
The Food and Drug Administration (FDA) announced in December 2004 important new information on side effects associated with the use of Bextra, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) which is indicated for the treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain). A "boxed" warning, strengthening previous warnings about the risk of life-threatening skin reactions and a new bolded warning contraindicating the use of Bextra in patients undergoing coronary artery bypass graft (CABG) surgery will be added to the label
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Bextra Information
Bextra Information
BEXTRA SIDE EFFECTS
The new boxed warning in the label states that patients taking Bextra have reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis. These skin reactions are most likely to occur in the first 2 weeks of treatment, but can occur any time during therapy. In a few cases, these reactions have resulted in death.
As of November 2004, FDA had received reports of a total of 87 cases in the United States of severe skin reactions in association with Bextra, including Stevens-Johnson Syndrome and toxic epidermal necrolysis. Twenty of the 87 cases involved patients with a known allergy to sulfa. Of these 87 cases, 36 hospitalizations were reported, including 4 deaths. Other Cox-2 selective inhibitors and traditional NSAIDs such as naproxen and ibuprofen also have a risk for these rare, serious skin reactions, but the reported rate of these serious side effects appears to be greater for Bextra than for other COX-2 agents
In addition to highlighting serious skin reactions, the strengthened label warnings also highlight new data about cardiovascular risks. A recently-completed study conducted by Pfizer, which included over 1,500 patients treated after CABG, showed an increased cardiovascular risk in patients treated with Bextra compared to placebo. Observed cardiovascular events included thromboembolic events such as myocardial infarction (heart attack), cerebrovascular accident (stroke), deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung).
Pfizer submitted the final report of the new CABG study to FDA on November 5, 2004. The report confirms the risk of the intravenous form (about 2 percent of patients had such an adverse event) and also shows that oral Bextra is associated with a lower, but some, risk (about 1 percent of patients) immediately following CABG surgery--a very specific medical setting. In the placebo group, about 0.5 percent of patients had an adverse cardiovascular event. Bextra is not approved for use in the treatment of postoperative pain of any type; however, FDA believes that these new findings should be made available to healthcare professionals and patients, and the bolded warning specifically contraindicates Bextra for treatment of pain immediately following CABG.
BEXTRA CLASS ACTION LAWSUIT
Pfizer is the target of a class action lawsuit filed November 12, 2004 alleging the company violated the Illinois Consumer Fraud and Deceptive Business Practices Act. The suit is seeking up to $75,000 per class member with allegations that Pfizer failed to provide proper warning about its arthritis drug Bextra to doctors and consumers in package inserts and reference manuals for doctors. Barbara Mihalich filed the Bextra class action lawsuit.
BEXTRA RECALL
Bextra was removed from the market on April 7, 2005 at the request of the FDA. The FDA cited inadequate information on possible heart risks from long-term use of the drug as well as life-threatening skin reactions, including deaths. The regulatory agency also called for the strongest warning possible on Pfizer's other arthritis product, Celebrex.
FINDING A BEXTRA CLASS ACTION LAWSUIT LAWYER
The law firms featured at the top of the page can assist you with filing your claim in the Bextra Class Action Lawsuit, or in filing a seperate lawsuit, outside the Class Action.
