Topical calcineurin inhibitors (pimecrolimus and tacrolimus) are a class of eczema medication. They help to suppress the signs and symptoms of eczema (itching, redness and inflammation) which are a reaction caused by a local immune response. They are applied to the skin twice daily for as long as the signs and symptoms persist.
Health Canada issued a Public Health Advisory on April 27, 2005, advising Canadians about the appropriate use of these products. The advisory stressed that these medications should be used according to approved labelling (i.e., the instructions provided by the manufacturer and approved by Health Canada). It also referred to a recent US Public Health Advisory which was issued to inform health care professionals and patients about a potential cancer risk from using these two medications. After review of all submissions, the Pediatric Advisory Committee felt there was a theoretical risk of the occurrence of malignancies based solely on animal data, although they recognized the lack of such a signal in humans to date.
What did the animal studies and case reports find? Data from animal studies showed that study animals developed blood and skin cancers. The data also included a small number of reports of cancer in children and adults taking these medications. For cases where sufficient information was available, these reports were assessed by external experts as unlikely to be linked to the use of topical calcineurin inhibitors.
At this point in time, the role of topical calcineurin inhibitors in the development of cancer is uncertain. It may take human studies of ten years or longer to determine if the use of these medications is linked to cancer. The manufacturers of these medications are proactively conducting long-term studies to find out more about the long-term safety profile of these medications, including the risk of cancer.
Until we have more information, it's important to use these medications exactly as directed by your physician:
- Pimecrolimus and tacrolimus should be reserved for cases where other eczema treatments are inappropriate or ineffective.
- These medications should not be used for children under two years of age because the effect on the developing immune system is unknown.
- Use only the appropriate amount of medication needed to control your eczema symptoms.
- These medications should only be used for short-term and long-term intermittent treatment (short treatment periods with breaks in between treatments) as directed by your doctor. They are not intended to be used continuously.
- People with weakened immune systems should not use these medications.
If you are concerned about your risk of cancer or would like more information, talk to your doctor or pharmacist.
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