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Bextra® medication (generic name Valdecoxib) is used to relieve pain, tenderness, inflammation and stiffness caused by arthritis. In a class of drugs called Cox-2 inhibitors, the entrance of Bextra® medication and other cox-2 drugs were seen as a breakthrough in pain relief. Bextra® medication works by stopping the production of "bad" prostaglandins that causes pain and inflammation but created hype because of its ability to allow the "good" prostaglandins to protect the stomach. As a result, unlike other traditional pain medications, the cox-2 drugs like Bextra® medication boasted it did not carry the risks of stomach problems like bleeding ulcers. These claims soon began to be questioned, with the benefits of Bextra® medication appearing to be too good to be true.

A 2000 study on the cox-2 drug Celebrex® published in the Journal of the American Medical Association showed people taking Celebrex® had fewer ulcer complications than people using over-the-counter drugs. Although this implication on cox-2 drugs like Bextra® medication was a bit of a blow to the drugmakers initially believing the risk had been eliminated completely, there still seemed to be some advantageous effects of using a cox-2 over traditional medications. Since the Celebrex® study just focused on six months of drug use, the FDA performed a later analysis looking at 12 months of data.

Instead, the FDA analysis showed the advantage of cox-2 drugs like Bextra® medication had completely disappeared by the 12 months time. There were great hopes that cox-2 drugs were going to be able to eliminate this problematic side of earlier pain medication, but now evidence was indicating Bextra® medication and other cox-2 drug claims were not living up to the once highly anticipated drug benefits. Especially among patients using a low-dose aspirin in conjunction with their Bextra® medication, or other cox-2s drugs to prevent heart disease, the benefit is lost, which is viewed as very problematic from a clinical point of view.

Over the years, hints that some of the cox-2 inhibitors might increase the risk of heart attacks have been especially worrisome. This has further complicated the safety debate over if Bextra® medication and other cox-2 drugs are really superior over traditional over-the-counter medications. A 2004 study by Novartis comparing its clinical trial cox-2 drug to other popular cox-2 drugs like Bextra® medication is the largest to date study on adverse effects. While this study can offer insight to what Bextra® medication side effects might exist, experts do caution more study is needed. By closer examining heart patients and other high-risk heart disease and digestive system patients, determining if cox-2 drugs like Bextra® medication increases risks of heart attacks and other adverse effects among all patients or certain high-risk patients can be better understood.

"Bextra Suit Filed"

Bextra , the popular cox-2 inhibitor recalled by Pfizer, is the subject of another lawsuit.

Rita Fohne has filed her lawsuit against Pfizer in Madison County, Illinois, seeking ...

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"FDA issues drug warnings on its Web site"

The U.S. Food and Drug Administration has started issuing alerts to patients and doctors on its new site Drug Watch. Including emerging drug-safety concerns, as well as dangers presented by drugs prescribed for unapproved uses, the new site is in resp...

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"FDA to listen to outside advisers in hopes of improving drug-monitoring system"

After a controversial year of drug recalls, the FDA was under attack for failing to adequately protect consumers from dangerous drugs. Currently, the FDA has the Adverse Event Reporting System, or AERS, to collect voluntary reports of possible reactio...

» Read More

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