SJS and TEN are Severe Acute Life-threatening, Drug-induced Skin Disorders Linked to Bextra and Celebrex
Stevens-Johnson syndrome and toxic epidermal necrolysis are closely related severe acute life-threatening, drug-induced skin disorders. The FDA Adverse Events Reporting System (AERS) has received reports of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of Bextra and Celebrex, selective cyclo-oxygenase (COX)-2 inhibitor NSAIDs which are also sulfonamides.
A study published in the January 1, 2005 edition of the medical journal Drug Safety -- "Comparison of Reporting of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Association with Selective COX-2 Inhibitors", by L La Grenade, et. al. -- reviewed cases of Stevens-Johnson syndrome ("SJS") and toxic epidermal necrolysis ("TEN") reported to the FDA which were associated with the use of the selective COX-2 inhibitor NSAIDs Celebrex, Vioxx, and Bextra. The researchers compared the reporting rates of SJS and TEN associated with these drugs to each other and the background incidence rate for these serious skin reactions.
After reviewing all U.S. cases of SJS and TEN reported to the FDA AERS database that were associated with the use of Celebrex, Vioxx, and Bextra up to the end of March 2004, the researchers found that there were 63 cases of Stevens-Johnson syndrome / toxic epidermal necrolysis reported with Bextra use, 43 SJS / TEN cases with Celebrex, and 17 with Vioxx, the non-sulfonamide COX-2 inhibitor NSAID. The researchers then used this data to determine that in the first 2 years of marketing for each of these drugs, the reporting rate for Stevens-Johnson syndrome / toxic epidermal necrolysis with Bextra was 49 cases per million person-years of use, 6 cases per million person-years for Celebrex, and 3 cases per million person-years for Vioxx. The reporting rates for the sulfonamide COX-2 inhibitor NSAIDs Bextra and Celebrex were substantially higher than the background rate of 1.9 cases per million population per year. Of particular significance was the finding that the Bextra SJS / TEN rate 8-9 times more than that of Celebrex and approximately 25 times greater than the background incidence rate for these serious skin reactions.
Based on these findings, the researchers concluded that there is a strong association between Stevens-Johnson syndrome / toxic epidermal necrolysis and the use of the sulfonamide COX-2 inhibitors, particularly Bextra. Accordingly, in the January 2005 Drug Safety article these researchers stress that doctors should be aware of the possibility of SJS or TEN events when prescribing Bextra or Celebrex, and they should advise their patients to discontinue use of these COX-2 inhibitor NSAIDs at the earliest possible sign of a skin rash.
(Posted by: Tom Lamb)