 |
|
|
 |
The Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Nonsteroidal Antiinflammatory Drugs: A Multinational Perspective
MAJA MOCKENHAUPT, JUDITH PARSELLS KELLY, DAVID KAUFMAN, ROBERT S. STERN, and the SCAR Study Group
ABSTRACT.
Methods. Three large data sources were analyzed: an international case-control study on severe cutaneous reactions (SCAR Study), a population based registry in Germany, and the US Food and Drug Administration (FDA) spontaneous reporting system. Results. In the international case-control study, the oxicams were associated with the greatest increase in risk of SJS and TEN (relative risk 34, 95% confidence interval 11–105). When the risk for only recently initiated use was compared to that for longterm use of these agents (> 8 weeks), the relative risk of SJS and TEN associated with oxicams was significantly increased (p < 0.05). German data registry confirm these findings. The incidence of spontaneous US reports of SJS and TEN (per 1,000,000 visits with a prescription) for diflusinal, sulindac, oxaprozin, and etodolac were not significantly lower than that of piroxicam (p > 0.05, all comparisons). Conclusion. Although the absolute risks of SJS and TEN associated with NSAID use are low, these risks should be considered in monitoring patients who recently began therapy. In 3 independent databases, oxicams have higher risk of SJS and TEN than other NSAID widely used on the 2 continents. The FDA spontaneous reporting systems suggest some NSAID not widely used in Europe may have risks comparable to the oxicams. (J Rheumatol 2003;30:2234-40) Key Indexing Terms:
STEVENS-JOHNSON SYNDROME
From the Dokumentationszentrum schwerer Hautreaktionen, Freiburg, Germany; Slone Epidemiology Unit, Boston University School of Medicine; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA. Supported by grants from the European Communities (BIOMED BMH1 CT92-1320), INSERM (contract 900812), and FRM, France; Ministry for Research and Technology (BMFT, grant No. 0701564/4) Germany; private donation (Mrs. Lombardi), Italy; Sunnybrook Research Fund, Canadian Dermatology Foundation, and the following: Bayer, Boehringer Ingelheim, Bristol, Ciba-Geigy, Cilag, Edol, Fidelis, Glaxo, Goedecke Parke-Davis, Hoechst, Hoffman-LaRoche, Janssen, Lederle, Medinfar, Parke Davis, Pharmacia, Pfizer, Merck Sharp and Dohme, Procter-Gamble, Lilly, Riom, Roche, Roussel-UCLAF, Sandoz, Schering Plough, Searle, Sigma, Smith Kline Beecham, SPECIA, Sterling-Winthrop, Stiefel, Syntex, Synthelabo, UPSA, Wellcome. M. Mockenhaupt, MD, Research Dermatologist, University of Freiburg; J.P. Kelly, MS, Epidemiologist, Slone Epidemiology Center; D. Kaufman, ScD, Associate Director, SCD, Slone Epidemiology Center; R.S. Stern, MD, Carl J. Herzog Professor of Dermatology, Harvard Medical School. Address reprint requests to Dr. R.S. Stern, Beth Israel Deaconess Medical Center, Department of Dermatology, 330 Brookline Ave, GZ 522, Boston, MA 02215. E-mail: rstern@caregroup.harvard.edu Submitted October 15, 2002; revision accepted February 13, 2003. |