Skin cancer associated with calcineurin inhibitors treatment: analysis of FAERS database.

Background: Several studies have indicated a potential link between calcineurin inhibitors (CNIs) and skin cancers. However, comprehensive evidence of CNI-induced skin cancers remains lacking.

Research design and methods: We conducted an observational retrospective pharmacovigilance study utilizing the FAERS database to identify potential risk signals associated with skin cancers with CNIs treatment, encompassing data from its inception to the third quarter of 2023. The assessment was carried out using the Information Component (IC) and Reporting Odds Ratio (ROR).

Results: We identified 1339 cases of skin cancers linked to CNIs use. The frequency of skin cancers associated with both CsA and Tac was significantly higher compared to all other drugs in the database, especially for nonmelanoma skin cancer (NMSC). There was no significant difference in the risk of CsA-related melanoma skin cancer (MSC) and NMSC compared to Tac. Additionally, the development of MSC appeared to have a higher risk of fatal outcomes in individuals of Caucasian descent and patients aged 40-79 years.

Conclusions: Our study has provided new real-world evidence regarding the safety of CNIs concerning skin cancers. It is recommended that clinicians remain vigilant about CNI-associated skin cancers and implement early surveillance to prevent adverse outcomes.