Tacrolimus ointment (Protopic): possible risk of malignancies including lymphomas and skin cancers

Healthcare professionals reminded that tacrolimus may be associated with possible risk of malignancy.

Article date: June 2012

Tacrolimus ointment (Protopic) is used to treat moderate to severe atopic dermatitis flares, and to maintain flare-free intervals, in adults and adolescents age 16 years and older, who do not respond to, or are intolerant of, conventional therapies such as topical corticosteroids.

Protopic is available in 2 strengths containing tacrolimus 0.03% and 0.1%, respectively. The lower strength ointment can be used to treat moderate to severe atopic dermatitis in children of 2 years and above, as well as adults and adolescents. The higher strength ointment is licensed only for use in patients aged 16 years and older.

Risk of malignancies

Healthcare professionals are reminded that tacrolimus may be associated with a possible risk of malignancy. Benign as well as malignant neoplasms including Epstein-Barr virus-associated lymphoproliferative disorders and skin malignancies have been reported in association with oral (systemic) tacrolimus treatment.

Cases of malignancies, including lymphomas and skin cancers have also been reported in patients using topically applied tacrolimus since it was licensed in 1999. In addition, findings from epidemiological studies have suggested a possible increased risk of cutaneous T-cell lymphoma in patients treated with topical calcineurin inhibitors, including tacrolimus ointment[footnote 1] [footnote 2] [footnote 3].

Healthcare professionals must remember that Protopic should not be prescribed to patients younger than 2 years, and that the use of Protopic in children aged 2 – 16 years is restricted to the lower strength 0.03% ointment only.

In addition, Protopic should not be applied to lesions that are considered to be potentially malignant or pre-malignant, or used in patients with congenital or acquired immunodeficiencies, or in patients on therapy that causes immunosuppression.

Further information

Letter to health professionals sent in May 2012

BNF section 13.5.3: Drugs affecting the immune response

Article citation: Drug Safety Update June 2012, vol 5 issue 11: S1

  1. Hui RL et al. Ann Pharmacother 2009; 43 (12):1956-1963 

  2. Schneeweiss S et al. Dermatology 2009; 219(1): 7-21 

  3. Arana A et al. Presentation at the annual meeting of the International Society for Pharmacoepidemiology, Brighton, UK 2010 

Published 11 December 2014