Evaluation of the US Food and Drug Administration sentinel analysis tools in confirming previously observed drug-outcome associations: The case of clindamycin and Clostridium difficile infection.
Ryan M CarnahanJennifer L KuntzShirley V WangCandace FullerJoshua J GagneCharles E LeonardSean HennessyTamra MeyerPatrick ArchdeaconChih-Ying ChenCatherine A PanozzoSengwee TohHannah KatcoffTiffany WoodworthAarthi IyerSophia AxtmanElizabeth A ChrischillesPublished in: Pharmacoepidemiology and drug safety (2018)
This evaluation produced an expected result and identified several potential enhancements to the Propensity Score Matching tool. This study has important limitations. CDI risk may have been related to factors other than the inherent properties of the drugs, such as duration of use or subsequent exposures.