Bextra - An Overview

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Bextra (Valdecoxib) is a non-steroidal anti-inflammatory COX-2 inhibitor similar to Vioxx and Celebrex. The FDA approved it in November 2001 for the treatment of osteoarthritis, rheumatoid arthritis, and dysmennorrhea (painful menstruation). Less than four years later, in April 2005, the FDA asked the manufacturer, Pfizer, to voluntarily withdraw Bextra from the market because the overall risk versus benefit profile was unfavorable. Pfizer complied, but maintains that the drug was thoroughly evaluated and is safe.

After Vioxx was recalled in 2004, the FDA began to examine all the COX-2 inhibitors more closely to see if drugs other than Vioxx were associated with an increased risk of having a heart attack, stroke, or other cardiovascular problems. They discovered that there was an increased risk of heart problems in people who took Bextra, especially if they had pre-existing heart disease. This seems to be a problem with all the medications in this class, the so-called non-steroidal anti-inflammatory drugs (NSAIDs).

NSAIDs are also common culprits in gastrointestinal complications, such as vomiting, diarrhea, and gastric bleeding. These side effects are caused by most NSAIDs, even aspirin one of the few NSAIDs that doesn't cause an increase in risk of heart disease.

In addition to the cardiovascular and gastrointestinal problems that Bextra causes, the medication has also been associated with an increased incidence of skin problems. These skin problems are normally due to a hypersensitive reaction to viruses or environmental factors. However, the most extreme forms of the diseases are almost always caused by the use of certain medications. All the non-steroidal anti-inflammatory medications can cause them, but the effect of Bextra seems to be more pronounced.

These skin problems aren't just a rash or hives. Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Erythema Multiforme are serious, sometimes fatal, skin problems.

Erythema multiforme (EM) is the least serious of these skin diseases, and is relatively common. A minor case of EM may look like a rash on the soles of the feet, the palms, and backs of the hands. If it becomes more serious, the distribution of the rash can spread to the arms, legs, face, and trunk. The lesions get bigger, too, and can begin to overlap. As they enlarge, they form rings around the original lesion, creating a characteristic target appearance. People often feel like they have the flu, with muscular aches, headache, and fever.

Stevens-Johnson Syndrome is sometimes seen as an advanced form of EM in which the mucus membranes are also involved. Mucus membranes line the mouth, nose, eyes, and vagina. The lesions often develop blisters, which leave open sores.

When Stevens-Johnson Syndrome involves more than 30 percent of the body's surface, it is called toxic epidermal necrolysis (TEN). TEN is very serious and sometimes fatal. The blisters can progress to large, fluid-filled bulges, and skin can begin to slough off. The result is similar to a major burn, in which nerve endings are exposed to the air and you lose large amounts of fluid through the open sores. It is excruciatingly painful and disfiguring, and the open lesions can easily become infected.

Pfizer reluctantly withdrew Bextra. They recalled the drug and made a statement that politely disagreed with the FDA as to its danger to human health. However, if you or a loved one took Bextra and experienced any of these side effects, the withdrawal of the drug from the market may have come too late, and you may be entitled to compensation. Contact a personal injury attorney an experienced lawyer will be able to determine whether or not you or your loved one has a viable case.