Lh. Kahn et Ba. Styrt, NECROTIZING SOFT-TISSUE INFECTIONS REPORTED WITH NONSTEROIDAL ANTIINFLAMMATORY DRUGS, The Annals of pharmacotherapy, 31(9), 1997, pp. 1034-1039
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.