First approved by the U.S. Food and Drug Administration (FDA) in November 2001, Bextra® (generically referred to as valdecoxib) is a prescription medication that was pulled from U.S. markets in 2005 due to mounting concerns that the drug had the potential to cause serious, life-threatening side effects.
Available in tablet form, Bextra® was prescribed to patients suffering from:
Bextra® was produced by G.D. Searle & Company (which is now a subsidiary of Pfizer) and it is classified as an NSAID (nonsteroidal anti-inflammatory drug). Despite it's ability to effectively manage pain, Bextra® has been reported to increase the likelihood that patients taking this medication will suffer a heart attack, stroke, angina or Stevens-Johnson syndrome.
Often misdiagnosed, Stevens-Johnson syndrome is a serious condition in which up to 30 percent of the body is afflicted with severe cell death in the mucous membranes (including those in the mouth, nose, eyes, genitals and the lower respiratory tract). While the epidermis (the outer most layer of skin) separates from the dermis (the middle layer of skin), patients may also experience any combination of the following symptoms:
When SJS affects more than 30 percent of a person's body, the condition is referred to as toxic epidermal necrosis syndrome (TENS)—and it is far more deadly. Although the cause of these skin disorders is often unknown, some of the most commonly known causes include serious infection and severe reaction to some medications, such as Bextra®. Treatments for both conditions call for internment in an intensive care unit (or a burn unit), as well as use of corticosteroids, intravenous fluid and, in some cases, antibiotic medications.
The American Medical Journal reports that patients who have less than 10 percent of cell damage will have a mortality rate of approximately 5 percent. However, even those who survive can sustain permanent disabilities, including severe organ damage and blindness.