Empirical assessment of case-based methods for identification of drugs associated with acute liver injury in the French National Healthcare System database (SNDS).
Nicolas H ThurinRégis LassalleMartijn SchuemieMarine PénichonJoshua J GagneJeremy A RassenJacques BenichouAlain WeillPatrick BlinNicholas MooreCécile Droz-PerroteauPublished in: Pharmacoepidemiology and drug safety (2020)
SCCS adjusting for multiple drugs and using exposed time as the risk window performed best in generating ALI-related drug safety alert and providing estimates of the magnitude of the risk. This approach may be useful for ad-hoc pharmacoepidemiology studies to support regulatory actions.