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.

According to the FDA, there were two problems with Bextra: an increased incidence of heart problems and an increased of serious skin diseases.

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.

Bextra was also associated with an increased incidence of skin problems. These skin problems are due to a hypersensitivity reaction to viruses, medications, or environmental factors. 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 is the least serious form of this skin disease. 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 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% of the body’s surface, it is called Toxic Epidermal Necrolysis. TEN is very serious and sometimes fatal. The blisters can progress to large, fluid-filled bulge, 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.

If you took Bextra and experienced any of these side effects, you should know that there’s pretty good evidence that Pfizer and the FDA knew that Bextra was dangerous before it was released. They were aware of at least 20 reports of Stevens-Johnson Syndrome in the US, and they approved and marketed the drug anyway. It wasn’t removed from the market until after the public became aware that similar drugs cause heart problems.