Bextra (Cox-2 Inhibitor, valdecoxib) FAQs

What is Bextra?

Bextra is the brand name of valdecoxib. It is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It is a Cox-2 inhibitor, meaning that Bextra works by inhibiting cyclooxygenase enzymes that induce inflammation and pain in patients.

Bextra was introduced to the market with FDA approval in november 2001 as a treatment for osteoarthritis, acute pain management, menstrual symptoms, and relief from the symptoms of rheumatoid arthritis in both adults and children.

Who is the manufacturer of Bextra?

Bextra is manufactured and sold by Pfizer, Inc. (PFE)

Why was Bextra withdrawn from the market?

The FDA concluded that Bextra has an increased risk of cardiovascular events with long-term use. This conclusion is strongly supported by the significant increase in cardiovascular risk seen in those patients who had just undergone heart surgery and the fact that other COX-2 selective NSAIDs have demonstrated such increased cardiovascular risk in long-term studies. In addition, Bextra already carries a boxed warning related to its increased risk of serious, life-threatening skin reactions, which have been reported at a much higher rate than for other COX-2 selective inhibitors. Finally, there are no data to suggest that Bextra has benefits that would outweigh these risks. Bextra has not been shown to offer any advantages over other existing NSAIDs. Therefore, the FDA concluded that the overall risk versus benefit profile of Bextra is unfavorable.

What information did the FDA review to arrive at its decisions?

The FDA's Center for Drug Evaluation and Research (CDER) considered the risk/benefit profile for each of the drugs Cox-2 selective drugs, and the cardio-vascular risks of NSAIDs as a class. We reviewed the regulatory histories and NDA databases of the various NSAIDs, FDA and sponsor background documents prepared for the joint Advisory Committee meeting, all materials and data submitted by other stakeholders to the Advisory Committee meeting, presentations made at the joint meeting, the discussions held by the Committee members during the meeting, and the specific votes and recommendations of the joint Committee.

What are some of the side effects of Bextra?

The following are all considered possible side effects:

• Increased risk of heart attacks
• Various cardiovascular events
• Gastrointestinal bleeding
• Abdominal pain, tenderness, or discomfort
• Bloody, black, or tarry stools
• Nausea or heartburn
• Bloody vomit
• Unexplained weight gain
• Swelling or water retention
• Unusual fatigue or lethargy
• Yellowing of the skin or eyes
• Flu-like symptoms
• Unusual bruising or bleeding

What are other common Cox-2 inhibitor drugs?

Vioxx and Celebrex are the two most common.

Why didn't the FDA also recommend that Celebrex be withdrawn?

The FDA stated: "The Advisory Committees were unanimous in their conclusion that an increased risk of cardio-vascular adverse events has been demonstrated for Celebrex (as for all the Cox-2 selective inhibitors) but strongly supported the continued marketing of the drug. FDA has concluded, based on the available data, that the benefits of Celebrex outweigh its potential risks in properly selected and informed patients. This conclusion is based on our review of the available safety data and the long-term controlled clinical trial comparisons of Celebrex to non-selective NSAIDs. While it appears that Celebrex is associated with an increased risk of serious cardio-vascular adverse events, the available data do not support a conclusion that Celebrex is significantly worse than the non-selective NSAIDs. The NSAID class boxed warning regarding increased cardio-vascular and gastrointestinal risks will be applied to Celebrex, and in addition the labeling will include additional information as described in question 2 above that will inform physicians and patients of the potential risks and allow for informed prescribing decisions."

What types of patients are at the highest risk for dangerous Bextra side effects?

Patients immediately post-operative from cardiovascular bypass surgery (CABG) and people who have coronary artery disease (people who have known angina or who have had a heart attack), people who have 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 are considered to be at the highest risk for for dangerous side effects.

What should I do if I am currently taking Bextra?

The FDA encourages people taking Bextra to contact their physician to discuss discontinuing use and alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specific treatment needs.