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Many Canadian children have atopic dermatitis, which can last into adulthood. Eczema can have a lasting adverse effect on people’s lives, both physically and psychologically. Among the current treatment options for atopic dermatitis are topical calcineurin inhibitors, also known as topical immunomodulators. In Canada these topical medications are available as either Elidel ® cream or Protopic ® ointment. These topical agents can be used alone or in conjunction with other medication.
To ensure safety, clinical studies have been done on 38,000 people, including 14,000 children under the age of 17. Two cases of non-lymphoma cancer were discovered. There were no cases in children. Scientists usually expect to find three lymphomas among such a large group. In North America, nearly seven million patients are safely using Elide ® or Protopic ® products. In the spontaneous reporting program (which means that companies making medications and other treatments must report to government if there is an adverse affect in people taking their products), there were 25 cases of malignancy, four of them in children 2-16 years old, out of the nearly seven million patients on these medications (13 lymphomas). Normally, in a group of this size, the companies would expect to learn about 61 cases of lymphoma.
This means that not only were there fewer cases of cancer and lymphoma in both children and adults than scientists were expecting to find but also external experts have assessed these as unlikely to be linked to the use of Elidel ® cream or Protopic ® ointment. Please feel free to discuss the contents of this fact sheet with your dermatologist – your skin expert.
The Canadian Dermatology Association’s mission is to promote the highest quality standards of dermatologic care in Canada. Part of this mission is to help ensure that patients are prescribed safe and effective medications.
Also reference Fact Sheet.
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