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

Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 9216037 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1468-3083 (Electronic) Linking ISSN: 09269959 NLM ISO Abbreviation: J Eur Acad Dermatol Venereol Subsets: MEDLINE

Publication: Oxford : Wiley-Blackwell
Original Publication: Amsterdam ; New York : Elsevier Science Publishers, c1992-

Multiple Myeloma*/drug therapy ; Adverse Drug Reaction Reporting Systems* ; Immunosuppressive Agents*/adverse effects ; Immunosuppressive Agents*/therapeutic use ; United States Food and Drug Administration* ; Pharmacovigilance* ; Nitriles*; Humans ; United States ; Male ; Female ; Middle Aged ; Aged ; Case-Control Studies ; Hematologic Neoplasms/drug therapy ; Sebaceous Gland Neoplasms/chemically induced ; Immunologic Factors/adverse effects ; Thalidomide/adverse effects ; Adult ; Lenalidomide/adverse effects ; Pyrazoles/adverse effects ; Pyrimidines/adverse effects ; Tacrolimus/adverse effects ; Tacrolimus/therapeutic use ; Aged, 80 and over

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.
(© 2023 European Academy of Dermatology and Venereology.)

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0 (Immunosuppressive Agents)
0 (Immunologic Factors)
4Z8R6ORS6L (Thalidomide)
F0P408N6V4 (Lenalidomide)
82S8X8XX8H (ruxolitinib)
0 (Pyrazoles)
0 (Pyrimidines)
WM0HAQ4WNM (Tacrolimus)
0 (Nitriles)

Date Created: 20231210 Date Completed: 20240425 Latest Revision: 20240425

20240425

10.1111/jdv.19703

38071595