Severe necrotizing soft-tissue infections and nonsteroidal anti-inflammatory drugs.
BACKGROUND
Severe necrotizing soft-tissue infection (NSTI) is a rare but potentially life-threatening condition if not recognized and treated early. The use of nonsteroidal anti-inflammatory drugs (NSAIDs) has been implicated as a contributing factor, but their role remains debated.


OBJECTIVE
The aim of our study was to investigate the potential relationship between cases of NSTI recorded in the French Pharmacovigilance system and exposure to NSAIDs.


METHODS
Cases of NSTI and randomly selected matched noncase controls (without skin disease) were identified in the database of the Spontaneous Reporting System in France for the period 2000-2004. Exposure to NSAIDs and other factors were investigated using conditional logistic regression.


RESULTS
We found 38 cases of NSTI in 2000-04: 12 infants (0-23 months), 16 children (2-15 years) and 10 adults (>15 years), and we selected 228 controls. The median age of the sample was 4 years. Of the 38 cases, 25 were exposed to ibuprofen and 24 presented with varicella. The adjusted odds ratio for exposure to NSAIDs was 31.38 (95% CI 6.40-153.84), and 17.55 (95% CI 3.47-88.65) for viral infection. Other predisposing factors (diabetes, immunosuppression, injecting drugs) were not found to be associated, although this may have been due to the very small number of cases of NSTI/necrotizing fasciitis in adults reported in the database.


CONCLUSIONS
Despite the limitations related to a spontaneous reporting system, this study indicates a strong association between NSAID use and NSTI. Although it was not possible to conclude if NSAIDs increase the risk of necrotizing complications in all patients, their use may mask the symptoms and delay diagnosis.
Souyri
C
C
Department of Clinical Pharmacology, Pharmacovigilance Regional Centre, Toulouse University Hospital, Toulouse, France.
Olivier
P
P
Grolleau
S
S
Lapeyre-Mestre
M
M
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects*; D016022:Case-Control Studies; D002644:Chickenpox / Q000150:complications; D002648:Child; D002675:Child, Preschool; D005205:Fascia / Q000382:microbiology; D019115:Fasciitis, Necrotizing / Q000139:chemically induced* / Q000188:drug therapy / Q000382:microbiology; D005260:Female; D005602:France; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D011552:Pseudomonas Infections / Q000139:chemically induced* / Q000382:microbiology; D018461:Soft Tissue Infections / Q000139:chemically induced* / Q000382:microbiology; D013203:Staphylococcal Infections / Q000139:chemically induced* / Q000382:microbiology; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal