Valdecoxib skin reactions show distinct pattern

Last Updated: 2007-07-02 15:47:04 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Certain cutaneous adverse reactions to valdecoxib (Bextra, Pfizer) are distinct from Stevens-Johnson syndrome and toxic epidermal necrolysis, German researchers report in the June issue of the Archives of Dermatology.

Dr. Mirjana Ziemer of the University of Jena and colleagues note that following the withdrawal of valdecoxib in April, 2005 they re-evaluated German reports of severe skin reactions caused by the drug.

In particular, the investigators looked at the cases of 2 men and 3 women ranging in age from 46 to 83. All had been erroneously diagnosed as having Stevens-Johnson syndrome. A further case, involving a 61-year old woman, was confirmed as being Steven-Johnson syndrome and no particular drug was established as being the cause.

All of the other patients had developed extensive skin problems within 5 to 11 days of starting daily valdecoxib intake.

These involved extensive erythematous, target-like skin eruptions in addition to facial edema and dyspnea. Four of the patients had temperatures of up to 39.7 degrees C.

Only 2 of the patients developed small blisters locally. Moreover, the patients showed or only mild mucosal involvement or none, contrary to the extensive hemorrhagic erosions expected in Stevens-Johnson syndrome and toxic epidermal necrolysis.

Furthermore, say the investigators, "histologic changes, clinical pattern, and outcome demonstrated a distinct disease entity."

The researchers, who point out that no German patients have died in such circumstances, conclude that valdecoxib "induces severe skin reactions different from those of Stevens-Johnson syndrome and toxic epidermal necrolysis in clinical and histopathologic findings, course, and outcome."

Arch Dermatol 2007;143:711-716.