Identification of Signal of Clindamycin Associated Renal Failure Acute: A Disproportionality Analysis.

Abstract

Early signal detection from post-marketing studies play a vital role in the safety of patients. Recent case reports have indicated the association of clindamycin with renal failure acute. However, renal failure acute is not known to be associated with clindamycin. The aim of the study was the identification of the potential signal of clindamycin-associated renal failure acute. The OpenVigil 2.1-MedDRA-v24 was used to query the FAERS database. The Reporting Odds Ratio (ROR) with a 95% confidence interval, was used to assess the association between clindamycin and renal failure acute. A total of 22326 cases associated with renal failure acute were found in OpenVigil 2.1- MedDRA-v24. Among these 125 were associated with clindamycin. The ROR was found to be 3.2 (2.7, 3.8) which indicates a statistically significant association between clindamycin and renal failure acute reporting. The signal strength was decreased after removing the cases of concomitantly administered drugs, however, the association of clindamycin with renal failure acute reporting remains statistically significant. The subgroup analysis results have also shown a positive signal of clindamycin with renal failure acute. The current study identified a positive signal of clindamycin as renal failure acute. However, further validation and causality assessment are required.