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Although the overall incidence is estimated at 1/5000 to 1/50,000, the occurrence of fatal hepatotoxicity could be as high as 1/800 to 1/500 in these high-risk groups [11]

Small ups and downs are normal, but the overall trend should stay fairly stable

Historically, there was significant concern for notoriety bias (i.e., increased likelihood of case reporting when patients are exposed to a drug with a negative reputation), which was mitigated by studying disproportionality signals