Does Protopic increase chances of skin cancer? - The Rosacea Forum I have now been prescribed Protopic by my derm. He said to me that protopic does not in anyway increase your chances of getting skin cancer, neither does it make your skin more sensitive. Although there is a theoretical concern that topical immunomodulatory therapy with tacrolimus and pimecrolimus may increase the risk of cancer, there is no evidence to date to suggest an increased risk of cutaneous or visceral cancer. The european agency for the evaluation of medicinal products has not recommended any change to labelling or approval of these topical agents and a task force of the american academy of allergy, asthma and immunology Both tacrolimus and pimecrolimus are immunosuppressive calcineurin inhibitors which lead to plausible increased risks of cancer when administered systemically. The biological risks from these drugs have been verified in humans following oral therapy for transplantation in the case of tacrolimus and in animal models for both compounds. Therefore, there is theoretical concern that topical application of these compounds might similarly increase the risk to patients. This risk has led to the institution of long-term cohort studies and increased pharmocovigilance. The U.S. Food and Drug Administration (FDA) has regularly met to monitor the worldwide evidence of a signal for increased risk and following a meeting in February this year took the step of applying black box warnings to these products. The decision to do so was prompted by indiscriminate off-label usage in the U.S.A., particularly in the under 2-year age group where systemic absorption may be more significant and the immune system is still developing. Further, this was prompted by animal data showing increased risk with increased exposure.
