What real-world harms show up with imipenem/cilastatin?
Among 2,574 FAERS reports, imipenem/cilastatin AEs clustered in older men, often within 3 days, with strong signals for delirium, disorganised speech, and some unlabeled events such as cerebral atrophy.
Source
Real-world pharmacovigilance investigation of imipenem/cilastatin: signal detection using the FDA Adverse Event Reporting System (FAERS) database
Study at a glance
- Design
- Other — FAERS disproportionality analysis of imipenem/cilastatin as primary suspect, 2004 Q1–2023 Q4 (ROR, PRR, BCPNN, EBGM)
- N
- N=2574 · 2,574 AE reports (6,605 AEs) with IMI/CIL as primary suspect
- Population
- Spontaneous FAERS reports worldwide in which imipenem/cilastatin was the primary suspect drug
- Outcome
- Adverse-event signals by MedDRA SOC/PT, including onset time and previously unlabeled events
Structured fields used in claim comparison tables when every cited study has a complete layer.
What they did
Pulled FAERS cases with IMI/CIL as primary suspect (2004–2023) and ran ROR, PRR, BCPNN, and EBGM disproportionality analyses classified by MedDRA.
What they found
2,574 reports / 6,605 AEs; 57.89% male; 58.94% aged >60. Most AEs within 3 days. Signals spanned 24 SOCs. Unlabeled PTs included cerebral atrophy, toxic encephalopathy, language disorder, disorganised speech, dysphoria, and delirium (n=263, ROR 72.31).
The limits
What it doesn't show
Spontaneous reports cannot measure true incidence or prove causation; missing data, stimulated reporting, and no denominator limit risk estimates.
Key terms
- Imipenem/cilastatin (IMI/CIL)
- Carbapenem antibiotic plus renal dehydropeptidase inhibitor.
- FAERS
- FDA Adverse Event Reporting System of spontaneous safety reports.
- Primary suspect (PS)
- Reporter-designated drug most likely responsible for the AE.
- ROR
- Reporting odds ratio used to detect disproportionate AE signals.
- MedDRA PT/SOC
- Preferred terms nested in system organ classes for coding AEs.
- Disproportionality analysis
- Signal detection comparing how often an AE is reported with a drug vs others.
Flashcards
Research intelligence for this paper
See its role on concept claims, tensions it is part of, placement history, and related discoveries.
Quiz yourself
FAERS PS reports numbered about:
Common questions
How many PS reports?
2,574 reports (6,605 AEs) from 2004–2023.
Who was over-represented?
Men (57.89%) and people >60 years (58.94%).
When did AEs occur?
Most within 3 days of starting the drug.
New signals?
Examples include cerebral atrophy, delirium, and disorganised speech.
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