Manufacturer: Pfizer, Inc.
Date approved: November 2001
Status: Voluntarily withdrawn by manufacturer
Approved uses: Treating symptoms of osteoarthritis and rheumatoid arthritis in adults and in relieving painful menstrual cycles
Off-Label uses: General pain relief
Increased risk of cardiovascular events including heart attack and stroke when used in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs). Stevens-Johnson syndrome – a rare, sometimes fatal skin disease
Bextra Lawsuit Information
Bextra, or valdecoxib, is an anti-inflammatory drug used to treat symptoms of osteoarthritis and rheumatoid arthritis and to relieve painful menstrual cramps. Pfizer voluntarily withdrew Bextra from the market in 2005, after use of Bextra was shown to increase the risk of cardiovascular events, including heart attack and stroke. Bextra has also been linked to Stevens-Johnson syndrome, a sometimes fatal skin disease. SJS causes painful blistering and erosion of skin, rashes, and selling of skin and mucous membranes.
Pfizer Respectfully Disagrees with FDA Decision on Bextra
In April 2005, the Federal Drug & Food Administration (FDA) asked Pfizer Inc. to suspend sales of Bextra. Pfizer halted the sales of Bextra because the FDA determined that the health risks associated with the drug outweighed the prescription’s benefits. It has been estimated that 7 million patients were prescribed Bextra and that approximately 12.9 million prescriptions were written for Bextra in 2004. Bextra is a prescription COX-2 selective non-steroidal anti-inflammatory drug (NSAID).
Pfizer Inc. withdrew Bextra because of concerns that it caused increased heart attacks, strokes and a potentially fatal skin disease, Stevens Johnson Syndrome. At the time the FDA asked for Bextra’s removal the agency also said it would require tougher safety warnings on all NSAIDs, including the medications Celebrex, Mobic, Aleve and Motrin.
Bextra is in the same class of drugs as Merck & Co’s drug Vioxx, the COX-2 inhibitor pain reliever whose withdrawal from the market in September 2004 started the analysis of patient signals that Vioxx, like Bextra, caused increased rates of heart attacks and strokes in some people who took the medication. Although Merck initiated its own Vioxx withdrawal, Pfizer withdrew Bextra from the market reluctantly and at the time voiced concerns that the FDA was changing how it judged the value of medications. Pfizer chose to respectfully disagree with FDA’s position regarding the overall risk/benefit profile of Bextra.
In May 2005, in response to media inquiries, Pfizer issued the following statement:
“As previously communicated, Pfizer has suspended sales of Bextra (valdecoxib) pending further discussions with the U.S. Food and Drug Administration (FDA). Pfizer continues to believe that Bextra could be an important treatment option for certain patient populations. In the future, the company plans to discuss options with the FDA under which Bextra might be made available to those patients.”
Upon further review, the FDA informed Pfizer that, in the agency’s view, Bextra’s cardiovascular (CV) risk could not be differentiated from other NSAIDs. However, the agency concluded that the additional, increased risk of rare but serious skin reactions associated with Bextra (already described on its label) warranted its withdrawal from the market. These skin reactions included Stevens Johnson Syndrome, which is a rare, life-threatening reaction to medication – one of the most devastating of all adverse drug reactions.
Stevens Johnson Syndrome is characterized by inflammation of the mucous membranes of the mouth, throat, eyes, genital tract and intestinal tract. Ulcers inside the mouth are the most common, causing inflammation and irritation to the tongue, gums, and lips and can extend into the throat. Affected individuals may also have skin lesions, blisters and bleeding in the lips, eyes, mouth, nasal passage and genital areas. As SJS evolves, the skin literally sloughs off in sheets. Patients are typically treated in a hospital’s burn unit. If the skin lesions become infected, or the patient develops lesions in the lungs, it can cause death.
Bextra was originally prescribed to arthritis sufferers to relieve symptoms of osteoarthritis and rheumatoid arthritis. It was also prescribed to women in hopes of relieving PMS and painful menstrual cycles. A November 2004 study, presented to American Heart Association indicated that patients who took Bextra were more than twice as likely (as non-users) to suffer heart attacks or stroke. The study involved almost 6,000 patients, some who took Bextra and some who were given a placebo. To date, several COX-2 inhibitors have been banned due to the increased risk of stroke, heart attack, stomach ulcers, liver damage, and severe skin reactions among patients.
Some classes of patients were always at a higher risk of side effects and complications when taking Bextra. This includes patients immediately post-operative from cardiovascular bypass surgery (CABG) and people who had coronary artery disease (people who have known angina or who have had a heart attack), people who had cerebrovascular disease, people who have had a stroke or who currently have episodes known as TIA (transient ischemic attacks), and people with a history of stomach ulcers. It has been suggested that patients in these classes who were prescribed Bextra should consult with a specialist even if they did not have any immediate adverse side effects.
If you or a family member has suffered serious side effects or a fatal injury such as a heart attack or stroke after using Bextra, you or the family member may be eligible to file a claim against the drug manufacturer. Contact an attorney to discuss your legal rights.
Bextra Still Off the Market
Bextra ®, generic name Valdecoxib, is a prescription COX-2 selective non-steroidal anti-inflammatory drug (NSAID) manufactured by Pfizer, Inc. On April 7, 2005, the Federal Drug & Food Administration (FDA) asked Pfizer to suspend sales of Bextra and to withdraw the drug from all markets due to adverse Bextra side effects. Pfizer, Inc. immediately halted all sales in the United States and Europe.
The FDA convened a public advisory committee meeting in February 2005 to review the cardiovascular safety of all COX-2 inhibitors and related drugs. The results of the meeting of the Center for Drug Evaluation and Research (CDER) were released in April 2005.
The agency concluded that the overall risk versus benefit profile for Bextra was unfavorable. It was at that time that the FDA requested that Pfizer, the manufacturer of Bextra, to remove the drug from the market. The request was based on the following:
There was not enough adequate data on the cardiovascular (CV) safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.
Numerous reports from individuals (more than 7) of serious and potentially life-threatening skin reactions, including deaths, were linked to patients who used Bextra. The risks of these unpredictable reactions in individual patients occurred in patients both with and without prior histories of sulfa allergies. These adverse reactions were found in patients after short term and long-term usage.
Lack of any demonstrated advantages in taking Bextra compared with other non-steroidal anti-inflammatory drugs.
At the time of the request for the removal of Bextra from the market, the FDA also issued request letters to all manufacturers of non-steroidal anti-inflammatory drugs (NSAIDs). The request included strong labeling changes to their products that are called “black box warnings”. A black box warning is the strongest warning the FDA issues. These letters included recommended labeling changes for both prescription and over-the-counter (OTC) NSAIDs and the inclusion of a special medication guide (package insert) for the entire class of prescription products. The package insert must include a warning that highlights the potential for increased risk of cardiovascular (CV) events and information on serious, potential life threatening gastrointestinal (GI) bleeding associated with the use of Bextra
In making the above decisions, the Center for Drug Evaluation and Research (CDER) considered the risk/benefit profile for each drug. The COX-2 and NSAID drugs permitted to remain on the market with the new warnings were allowed to continue to be marketed because it was determined that the benefits of the medications outweigh their risks.
When Pfizer agreed to suspend sales and marketing of Bextra the company requested that the panel consider a future further review of Bextra. This has not occurred, and reports indicate the agency may not agree to the company’s request for re-marketing Bextra. With the recent FDA decision to remove Bextra from the market, hundreds of lawsuits have already been filed on behalf of Bextra users. Any individual that believes that they may have been damaged in any way from using Bextra should consult an attorney.
It is recommended that patients who were taking Bextra contact their physician to consider alternative treatments. Any individual that believes they may have been harmed or suffered adverse heath effects from the usage of Bextra should seek the advice of an attorney who specializes in this type of litigation.