NECROTIZING SOFT-TISSUE INFECTIONS REPORTED WITH NONSTEROIDAL ANTIINFLAMMATORY DRUGS

BACKGROUND: Recent reports of necrotizing fasciitis in children with v aricella who received a nonsteroidal antiinflammatory drug (NSAID) rec all earlier concerns regarding the possibility of relationships betwee n infections and NSAIDs. We searched the Food and Drug Administration' s Spontaneous Reporting System (SRS) for necrotizing soft tissue infec tions reported in conjunction with the use of NSAIDs, to identify comm on features. METHODS: A computer search of NSAID listings in the adver se event database recovered reports with code for selected infection a nd necrosis-related diagnostic categories. From review of individual r eports classified under these codes, cases were selected if the terms ''necrotizing fasciitis.'' ''necrotic,'' or ''gangrenous'' appeared in the adverse drug reaction description. Demographic, drug use, and dis ease course information were gathered. FINDINGS: Thirty-three cases we re identified, of which 10 were fatal. Over two-thirds of the patients were younger than 40 years. Thirty (91%) had a possible portal of ent ry for infection. Most received NSAIDs for acute conditions including varicella, trauma, and postoperative or postpartum pain: 7 received an NSAID by intramuscular injection. Specific NSAIDs accounting for most reports were also among those likely to be most heavily used in the r elevant populations. INTERPRETATION: Common features of these rare cas e reports of necrotizing soft tissue infections with NSAID use include characteristics such as age, porta of infection entry, indication for NSAID use, route of administration, and individual NSAIDs. The total number of SRS case does not suggest than necrotizing infection is freq uent with NSAIDs or likely without other risk factors. Controlled obse rvational studies would help to define any causal contribution of thes e factors to the evolution of severe infection.