Prescription and "over-the-counter" (OTC) NSAIDs, such as naproxen and ibuprofen, came under intense scrutiny after Merck & Co. voluntarily withdrew its blockbuster COX-2 inhibitor, Vioxx®, from the market in September 2004 after a clinical study linked the sustained use of the drug to an increased risk of heart attack or stroke.
Continued study of NSAIDs, including COX-2 inhibitors, led the FDA to conclude that the overall risk versus benefit profile of Bextra® was similarly unfavorable to that of Vioxx®. In response to the FDA's request, Pfizer, Inc., the manufacturer of both Bextra® and Celebrex®, voluntarily withdrew Bextra® from the marketplace on April 7, 2005. At the same time, the FDA concluded that the benefits of Celebrex® outweighed the potential risks in properly selected and informed patients, and allowed the drug to remain on the market. Pfizer was permitted to continue marketing Celebrex®, provided that the company:
Although Celebrex® has been linked to an increased risk of heart attack and stroke, the available research does not support a conclusion that the risk associated with Celebrex® is significantly greater than the risk associated with the other non-selective NSAIDs, except aspirin. To counter the risk, the FDA required the manufacturers of NSAIDs, including Celebrex®, to revise their labeling to include a "boxed" or serious warning highlighting the potential increased risks of cardiovascular events, as well as the risk of stomach bleeding. Celebrex® must also include a specific warning against patients taking the drug either right before or right after heart surgery.
Like Vioxx® and Bextra®, Celebrex® has been linked to an increased risk of heart attacks or strokes in patients who have taken the drug for long periods of time.
Patients taking Celebrex® have suffered bleeding ulcers, liver damage, kidney problems leading to kidney failure, and fluid retention.
If you want to file a lawsuit, you should find a lawyer as soon as possible. Each state has a time limit, called a statute of limitations, restricting how long you have to file your Celebrex® claim. The time limit varies from state to state. But if you wait too long, you will be barred from taking legal action.
When choosing a lawyer, you should look for someone who has experience dealing with Celebrex® lawsuits. After all, Pfizer has legal experts defending it against Celebrex® claims that are similar to yours. You should find a lawyer with proven experience in the field, someone who has the resources and contacts to deal with your case quickly and efficiently.
An experienced lawyer will be able to advise you about your options, including whether you should file an individual lawsuit or opt for a class action. Your lawyer may be able to advise you about your chances of success and give you an idea of how much compensation you can reasonably hope to recover.
Once you have selected a lawyer, you will need to provide information regarding:
The more information you provide your lawyer, the better chance he or she will have of preparing a solid Celebrex® case for you. As your case develops, your lawyer will be able to advise you about accepting an out-of-court settlement, if one is offered, or if you should go to trial.
If you're aware of a serious adverse reaction to Celebrex®, the FDA encourages you to make a MedWatch report (click on "How to Report," ) or call 1-800-FDA-1088.
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