Bextra Can Cause Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

SJS And TEN Are Serious Drug-induced Skin Reactions Which Can Be Fatal

Cases of Stevens-Johnson syndrome and toxic epidermal necrolysis caused by Bextra have been reported to the FDA. In fact, Stevens-Johnson syndrome -- commonly referred to as Stevens-Johnson or SJS -- and toxic epidermal necrolysis, or TEN, are closely related serious skin reactions.

In more detail, the FDA MedWatch program has received reports of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) associated with the use of Bextra and Celebrex, both of which are selective cyclo-oxygenase (COX)-2 inhibitor NSAIDs which are also "sulfonamides", as well as Vioxx, the non-sulfonamide COX-2 inhibitor NSAID.

Some reports of SJS and TEN made to the FDA are the subject of a study that was published in the January 1, 2005 edition of the medical journal Drug Safety. In that study, medical researchers determined the reporting rates of SJS and TEN associated with Bextra, Celebrex, and Vioxx (collectively known as the "COX-2 class of drugs"), then compared the rates of SJS and TEN among this COX-2 class of drugs, as well as the background incidence rate for SJS and TEN. By reviewing all cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) associated with the use of Celebrex, Vioxx, and Bextra that had been reported to the FDA up until the end of March 2004, these researchers found:

• 63 cases of SJS and TEN caused by Bextra use;
• 43 cases of SJS and TEN caused by Celebrex; and,
• 17 cases of SJS and TEN caused by Vioxx.

The researchers conducting that Drug Safety-published study then analyzed this data -- as well as the number of Bextra and Celbrex prescriptions dispensed during the relevant time period -- to determine that the reporting rates for Bextra and Celebrex (the sulfonamide COX-2 inhibitor NSAIDs) were substantially higher than the background rate of 1.9 cases per million population per year (pmp/yr). Specifically, they determined that Bextra had a incidence rate of 49 cases pmp/yr, and the Celebrex rate was 6 cases pmp/yr. Using these numbers, these researchers concluded that the Bextra SJS / TEN rate was 8-9 times more than that of Celebrex, and approximately 25 times greater than the background incidence rate for these two serious skin reactions.

In summary, the medical researchers determined that there is a "strong association" between the use of the sulfonamide COX-2 inhibitors, particularly Bextra, and Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).

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