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Necrotizing soft tissue infections reported with nonsteroidal antiinflammatory drugs
1Office of Epidemiology and Biostatistics, Food and Drug Administration, Rockville, MD, USA.
Background:
Recent reports of necrotizing fasciitis in children with varicella who received a nonsteroidal antiinflammatory drug (NSAID) recall earlier concerns regarding the possibility of relationships between infections and NSAIDs. We searched the Food and Drug Administration's Spontaneous Reporting System (SRS) for necrotizing soft tissue infections reported in conjunction with the use of NSAIDs, to identify common features.
Methods:
A computer search of NSAID listings in the adverse event database recovered reports with codes for selected infection and necrosis-related diagnostic categories. From review of individual reports 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 disease course information were gathered.
Findings:
Thirty-three cases were identified, of which 10 were fatal. Over two-thirds of the patients were younger than 40 years. Thirty (91%) had a possible portal of entry 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 relevant populations.
Interpretation:
Common features of these rare case reports of necrotizing soft tissue infections with NSAID use include characteristics such as age, portal of infection entry, indication for NSAID use, route of administration, and individual NSAIDs. The total number of SRS cases does not suggest that necrotizing infection is frequent with NSAIDs or likely without other risk factors. Controlled observational studies would help to define any causal contribution of these factors to the evolution of severe infection.
Insights
Nonsteroidal anti-inflammatory drug (NSAID) use may be associated with rare necrotizing soft tissue infections, particularly in younger individuals with a clear infection entry point. Further studies are needed to confirm NSAID
Area of Science:
- Pharmacovigilance
- Infectious Diseases
- Dermatology
Background:
- Recent reports link nonsteroidal anti-inflammatory drug (NSAID) use in children with varicella to necrotizing fasciitis.
- Concerns exist regarding potential associations between NSAID use and severe infections.
Purpose of the Study:
- To investigate necrotizing soft tissue infections reported with NSAID use.
- To identify common features in NSAID-associated necrotizing infections.
Main Methods:
- Searched the FDA's Spontaneous Reporting System (SRS) for NSAID-related necrotizing soft tissue infections.
- Selected cases mentioning "necrotizing fasciitis," "necrotic," or "gangrenous."
- Gathered demographic, drug use, and disease course data.
Main Results:
- Identified 33 cases of necrotizing soft tissue infections with NSAID use; 10 were fatal.
- Over two-thirds of patients were under 40 years old.
- Most patients had a portal of entry for infection and received NSAIDs for acute conditions.
Conclusions:
- Common features in these rare NSAID-associated necrotizing infections include patient age, infection entry site, NSAID indication, and route of administration.
- The number of SRS cases does not indicate frequent necrotizing infections with NSAIDs alone.
- Controlled studies are needed to establish causality between NSAIDs and severe infections.