A Service Review of Topical Tacrolimus-based treatment for Oral Mucosal Disorders in a Dental Hospital Oral Medicine Department

Introduction: Studies show topical tacrolimus to be effective across a spectrum of oral mucosal disorders including lichen planus, bullous diseases and plasma cell gingivitis. In 2005 the U.S. Food and Drug Association proposed a boxed warning for tacrolimus due to the lack of long-term safety data and potential risk of the development of malignancies. Currently, there is no conclusive evidence indicating that tacrolimus increases risk of malignant transformation of the oral mucosa.
Methods: A retrospective service review was undertaken which identified 86 patients that were prescribed topical tacrolimus across a 12-year period from 2011 to 2023. Patient data was extracted from an outpatient computerised prescription database and patient digital health records. There were 72 females and 14 males who were aged between 16 and 83 years. The majority of topical tacrolimus prescriptions were for oral lichen planus and the remainder were for a range of inflammatory mucosal diseases. Most patients were on additional topical steroids such as clobetasol and betamethasone. The duration of prescriptions issued was highly varied; the longest being over 11 years. According to the histopathological records in the study, none of the 86 patients in the cohort developed an oral malignancy.
Conclusions: Topical tacrolimus appears to be a long-term, well tolerated topical treatment for patients with a wide range of oral diseases. Literature states that in dermatology, topical tacrolimus has a causal relationship with skin malignancy. This service review suggests that the application of topical tacrolimus effectively addresses inflammatory oral mucosal diseases in patients, without posing an elevated risk of oral malignancies. Patients prescribed topical tacrolimus for inflammatory oral mucosal diseases continue to be added to a database for ongoing follow up.