Tacrolimus use linked to acute pancreatitis

A safety signal for acute pancreatitis among users of the calcineurin inhibitor (CNI) tacrolimus has been identified in an observational retrospective pharmacovigilance study.

Researchers used the Food and Drug Administration Adverse Event Reporting System (FAERS) database to investigate the association between CNIs and acute pancreatitis. Logistic regression analysis was performed.

A total of 221 cases of acute pancreatitis linked to CNIs were identified. These cases occurred among individuals with a median age of 43, with a predominance among men (54.95 percent). Most cases were concentrated in Europe (40.27 percent), followed by Asia (32.58 percent) and America (21.27 percent). In terms of outcomes, the events were generally serious, including hospitalization (38.01 percent) and death (31.67 percent).

CNIs were significantly associated with acute pancreatitis (reporting odds ratio [ROR], 1.82; information component [IC], 0.85). Among CNIs, tacrolimus and cyclosporine both posed an increased risk of inducing acute pancreatitis, with the safety signal seemingly higher for tacrolimus.

Additional analysis showed that the association between tacrolimus and acute pancreatitis was consistent in subgroups, except among older adults (age 60 and above). On the other hand, the association seen with cyclosporine was observed exclusively in men and among individuals in the under-20-years age group.

The mortality rate for CNI-related acute pancreatitis was 31.67 percent. Logistic regression analysis indicated that younger age was a protective factor for death due to CNI-related acute pancreatitis (odds ratio, 0.943, 95 percent confidence interval, 0.915–0.972; p=0.000).

The findings stress that healthcare providers be vigilant and informed about the potential association between CNIs and acute pancreatitis.