Reevaluating Drug Safety: Real-World Data Challenges Old Methods

A University of Pennsylvania study suggests that real-world data, rather than case reports, should be used to assess medication-related liver toxicity more accurately, potentially leading to better patient monitoring and safety.

A new study from the Perelman School of Medicine at the University of Pennsylvania indicates that the existing method for evaluating medication-related liver damage does not accurately reflect the true liver toxicity—or its absence—of certain drugs. Historically, the potential of a drug to harm the liver, known as “hepatotoxicity,” has been assessed by tallying reported instances of acute liver injury (ALI).

Instead, the researchers used real-world healthcare data to measure rates of ALI within a population and uncovered that some medications’ levels of danger to the liver are being misclassified. This paper was published today in JAMA Internal Medicine.