FDA CALLS FOR REMOVAL OF BEXTRA FROM MARKET

[Introduction: If you or a loved one had injuries consisting of a heart attack or stroke while on  Bextra, this may have been caused by exposure to this drug, and you may have a lawsuit that should be pursued. Although our Bextra lawyers are located in Maryland (MD), Virginia (VA) and Washington, D.C. (DC), our drug litigation is national in scope, and our Bextra lawyers are prepared to file lawsuits and litigate Bextra cases around the country. Therefore, regardless of what state you're from, please fill out our inquiry form on this web site or email us so that Ashcraft & Gerel, LLP can have a Bextra lawyer contact you to discuss your claim and the potential of a lawsuit.]

Bextra (valdecoxib), manufactured by Pfizer Inc., is a widely prescribed prescription arthritis pain medication in the United States. It is part of a class of pain medications known as Cox-2 inhibitors, of which there are three in total. Vioxx, one of the other two Cox-2 inhibitors, was withdrawn from the market on September 30, 2004 due to a study linking this pharmaceutical to heart attacks and strokes. On December 17, 2004, Pfizer Inc. announced that a study of Celebrex, the other remaining Cox- 2 inhibitor, showed that patients taking the drug daily had an approximately 2.5 fold increase in their risk of experiencing a major cardiovascular event.

On December 9, 2004, The Food and Drug Administration (FDA) announced that a ” black box ” warning needed to be placed on all packages and labels of Bextra. The new boxed warning in the label stated that patients taking Bextra have reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis. In addition to highlighting serious skin reactions, the strengthened label warnings also highlighted new data about cardiovascular risks. A recently-completed study conducted by Pfizer, which included over 1,500 patients treated after CABG (cardiac bypass surgery), 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).

On April 7, 2005 the FDA asked Pfizer, Inc. to withdraw Bextra from the market. The FDA’s announcement stated:

After concluding that the overall risk versus benefit profile is unfavorable, the FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This request is based on:

* The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.

* Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.

* Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

If you think you or a loved one may have suffered an injury or damages as a result of taking Bextra, you owe it to yourself to speak to an experienced drug or pharmaceutical attorney about the possibility of investigating the claim and bringing a lawsuit to recover for your damages and injuries. The attorney will be able to ascertain if you have a claim for which a lawsuit can be filed and that can be brought to a successful settlement, verdict, award or other recovery, and the experienced Bextra lawyer will be able to advise you on any deadlines for bringing your legal claim for damages. Please contact the law firm of Ashcraft and Gerel, LLP to discuss your case and the potential of a lawsuit with an experienced drug or pharmaceutical lawyer in our Drug Litigation Department. Many attorneys and law firms are now, for the first time, becoming involved in Vioxx, Celebrex, and Bextra claims, but Ashcraft & Gerel’s lawyers are among the few lawyers in the country who have been actively prosecuting lawsuits for Cox-2 related injury before Vioxx was recalled from the market, and our drug attorneys are well situated to see Vioxx, and Bextra lawsuits to successful verdicts or settlements.

The lawyers at Ashcraft and Gerel, LLP have been leaders in the prosecution of cases involving unsafe drugs. Our attorneys have successfully pursued lawsuits and brought about verdicts, settlements, awards or other recoveries in claims on behalf of clients who have been injured by Fen-Phen, Rezulin, Propulsid, Phenylpropanolamine (PPA), Baycol, breast implants and AIDS tainted blood. We have a toll free number to reach an attorney to answer your questions with regard to whether you have a lawsuit and, if so, the specifics of the case. That number is 1-800-829-7037. Please ask to speak to Robert Samet, and he will place you in touch with one of our Bextra lawyers. If you would prefer, please feel free to e-mail us or complete the help inquiry form on this web site. Please be sure to include your name, address, telephone number (if you wish to be called), email address and the exact nature of your question, so that our Bextra lawyer can provide you with the specific information you seek.