Association of Nonmelanoma Skin Cancers, Melanoma, and Merkel Cell Carcinoma with Dermatologic Medications: A Case-Control Pharmacovigilance Study of the FDA Adverse Events Reporting System.

BACKGROUND

Medications used in the treatment of dermatologic conditions have been associated with squamous cell carcinoma (SCC), basal cell carcinoma (BCC), melanoma, and Merkel cell carcinoma (MCC).

OBJECTIVE

The objective of the study was to examine the relationship between systemic dermatologic medications and skin cancer 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 (RORs) for SCC, BCC, melanoma, and MCC.

RESULTS

The oral immunosuppressants were all associated with increased ROR of SCC, BCC, melanoma, and MCC. Azathioprine had the highest ROR for SCC (34.13, 95% CI 29.07-40.08), BCC (21.15, 95% CI 20.63-25.98), and MCC (44.76, 95% CI 31.52-63.55), while quinacrine and guselkumab had the highest ROR for melanoma (13.14, 95% CI 1.84-93.89 vs. 12.73, 95% CI 10.60-15.30, respectively). The TNF-α inhibitors were associated with an increased ROR for all skin cancers investigated.

CONCLUSIONS

The oral immunosuppressants and many biologic medications were associated with an increased ROR of skin cancers including TNF-α inhibitors (etanercept, adalimumab, infliximab), IL-23 or IL-12/23 inhibitors (ustekinumab, risankizumab), and the CD-20 inhibitor rituximab but not dupilumab or IL-17 inhibitors.