Topical Immunosuppressants Drugs Don’t Increase Risk of Common Skin Cancers, Despite Warning Labels

Despite warnings on the packaging of 2 topical immunosuppressant medications frequently used to treat adults with the chronic skin condition atopic dermatitis, researchers found that these drugs do not appear to increase the risk for the most common forms of skin cancer, according to a study published in JAMA Dermatology.

Specifically, the analysis from researchers at the Massachusetts General Hospital found patients prescribed with topical tacrolimus or pimecrolimus were not at greater risk for either basal cell or squamous cell carcinomas compared to patients receiving prescription topical corticosteroids.

“We analyzed the data with multiple sensitivity analyses to explore the association of TCI use and skin cancer risk in detail, which revealed no association each time, so that was very reassuring,” Maryam M. Asgari, MD, MPH, investigator in the Department of Dermatology at Massachusetts General Hospital, said in a press release.

No association was found between topical calcineurin inhibitor (TCI) use and risk for either keratinocyte carcinomas overall, or for squamous cell or basal cell carcinomas individually. No differences were found when examining different doses, frequency, and duration of TCI use.

The researchers utilized a database maintained by Kaiser Permanente Northern California in Oakland. The database contains integrated pharmacy and pathology data regarding nearly 94,000 adults aged 40 or older diagnosed with atopic dermatitis or dermatitis by a clinician from January 2002 through December 2013.

Asgari and colleagues were able to “determine the proportions of patients who received prescriptions for TCIs vs. topical corticosteroids” because most Kaiser Permanente patients use the health plan’s pharmacy.

“I thought that the data implicating increased skin cancer risk with TCIs was not robust, and that prompted me to get involved in studying it,” Asgari said in a press release.

The FDA requires that TCI medications include a “black box” warning regarding the increased risk for skin cancer even though some studies have shown conflicting data regarding the correlation of TCI medications and skin cancer risk.

Long-term studies including patients with atopic dermatitis using these TCIs has been required by the FDA to get a better grasp of the potential risk of skin cancer.

Reference:

No increased skin cancer risk with topical immunosuppressant ointments, study finds [news release]. Boston, Massachusetts. Published August 12, 2020. https://www.massgeneral.org/news/press-release/No-increased-skin-cancer-risk-with-topical-immunosuppressant-ointments-study-finds. Accessed September 23, 2020.