What is Celebrex?
Celebrex? (celecoxib) is a type of prescription pain medication known as a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) or a COX-2 inhibitor. Celebrex?, Vioxx?, and Bextra? are the three so-called "miracle drugs" widely prescribed to relieve arthritis and menstrual pain. Both Bextra?; and Vioxx? were withdrawn from the marketplace in 2004 and 2005, respectively, because of associated health risks. Celebrex? remains available for prescription under careful monitoring by the U.S. Food and Drug Administration (FDA).
Why were Vioxx and Bextra Taken off the Market?
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:
- Revised and strengthened the Celebrex? label
- Encouraged physicians to prescribe the smallest effective dose for the shortest time possible
- Included a Medication Guide as part of the labeling to inform patients of the need to discuss with their doctor the risks and benefits of using NSAIDs and the importance of using the lowest effective dose for the shortest time possible
- Committed to conduct a long-term study of the safety of Celebrex? compared to naproxen and other appropriate drugs.
Why Did the FDA Allow Celebrex to Stay on the Market?
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.
What Risks are Associated with Taking Celebrex?
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.
Why is Pfizer Being Sued?
Both Merck and Pfizer spent hundreds of millions of dollars advertising their "miracle" pain relievers, especially Vioxx? and Celebrex?, directly to the public. Some argue that the aggressive ad campaigns created a false image of the drugs being absolutely safe. With both Vioxx? and Bextra? being pulled from the market because of the link to heart attacks and strokes and Celebrex? being linked to same cardiovascular risks, Celebrex? users question whether Pfizer knew more about the heart risks than the company admitted.
Who Can File a Celebrex Lawsuit?
If you have suffered a Celebrex?-related injury, or if you are a close family member of someone who died as a result of a Celebrex?-related injury, you may be able to file a Celebrex? lawsuit.
How Do I File a Celebrex Claim?
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:
- When and how long you took Celebrex?, as well as the dosage
- Whether you took Celebrex? regularly
- What type of Celebrex?-related injury you suffered, when the injury occurred, and whether you were taking Celebrex? at the time
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.
How Can I Report a Serious Side Effect With Celebrex to the FDA?
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.