Consciousness Disturbances Reported With Clindamycin Versus Cefazolin in Surgical Patients: A Global

Kazuki Nishida1,2, Basile Chrétien3, Hiroshi Morioka4

  • 1Department of Biostatistics, School of Public Health, Kyoto University, Kyoto, Japan.

Insights

Clindamycin use during surgery may be linked to more reported disturbances in consciousness compared to cefazolin, based on global safety data. Further research is needed to confirm this potential association and understand its clinical significance.

Area of Science:

  • Pharmacovigilance
  • Clinical Pharmacology
  • Drug Safety

Background:

  • Clindamycin is a common antibiotic substitute for surgical prophylaxis.
  • The association between clindamycin and peri-operative disturbances in consciousness is not well-established.

Purpose of the Study:

  • To investigate whether peri-operative disturbances in consciousness are disproportionately reported with clindamycin compared to other antibiotics.

Main Methods:

  • A de-duplicated case/non-case disproportionality analysis of WHO VigiBase Individual Case Safety Reports (ICSRs) was performed.
  • Cases were defined by "Disturbances in consciousness NEC." Reporting Odds Ratios (RORs) and adjusted RORs (aRORs) were estimated for clindamycin versus cefazolin and other comparators.
  • K-modes clustering analyzed co-reporting patterns; sensitivity analyses were conducted.

Main Results:

  • Clindamycin use was associated with a disproportionality signal for consciousness disturbances compared to cefazolin (aROR 2.23).
  • This signal persisted after excluding sepsis-related terms/vasopressors and syncope/presyncope.
  • Clustering revealed distinct co-reporting patterns based on age and co-medications.

Conclusions:

  • Pharmacovigilance data suggest a potential reporting signal for disturbances in consciousness with clindamycin versus cefazolin in surgical settings.
  • These findings are hypothesis-generating and require confirmation in data sources with denominators and prospective clinical studies.

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