Multiple myeloma, haematologic malignancy and immunosuppressant and immunomodulatory medications are associated with sebaceous carcinoma, a pharmacovigilance study of the FDA adverse event reporting system

Abstract Background Sebaceous carcinoma (SC) is a rare skin cancer with significant associated morbidity and mortality. A known association exists between immunosuppression, in particular solid organ transplant patients (SOTR), and SC. However, the comparative reporting odds ratios (ROR) of different immunosuppressive medications and SC are incompletely defined. Objectives To examine the relationship between SC and medication exposure in the FDA adverse event reporting system (FAERS). Methods Case–control analyses were performed in FAERS from 1968 to 2021 to examine the reporting odds ratios (ROR) for SC. Results A total of 58 medication‐associated SC cases were identified. Immunosuppressant medication exposure was noted in 81% cases, with 20% total cases occurring in SOTR. Medications affecting the TNF‐ α ‐IL‐1‐IL‐2‐IL‐6 inflammatory axis were associated with elevated ROR for SC, including thalidomide (ROR 22.63, 95% CI 5.52–92.72), lenalidomide (ROR 10.86, 95% CI 4.93–23.94), cyclosporine, tacrolimus, tocilizumab, tofacitinib and ruxolitinib. Thirty per cent of cases of SC occurred with an associated haematologic malignancy or dyscrasia, including chronic lymphocytic leukaemia, non‐Hodgkin lymphoma and multiple myeloma. Conclusions SC is associated with exposure to immunosuppressive medications, especially in SOTR patients. A significant portion of cases with SC had an associated haematology malignancy, in particular multiple myeloma with exposure to lenalidomide.