Elidel is used to treat atopic dermatitis, but according to the US Food and Drug Administration (FDA), Elidel should only be used as a second-line agent, meaning other treatments should be tried first. The reason for this is that some serious Elidel side effects have been linked to the medication, including an increased risk of cancer.
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As the FDA notes, the risk of cancer has only been shown in animal studies and in the case reports of a small number of patients. Any studies in humans determining a link between the cream and cancer would require at least 10 years to complete. In the meantime, patients who use the medication would do so without any certainty about whether Elidel is linked to an increased risk of cancer.The FDA, therefore, has listed some guidelines for what it considers safer use of Elidel. This includes not using Elidel on children younger than two years old—Elidel has been linked with an increased risk of upper respiratory infections in children and infants—using Elidel only for short times, not long term, and avoiding use of Elidel in children and adults who have a weakened or compromised immune system.
Finally, the FDA warns that only the minimum amount of Elidel needed to control the patient's symptoms should be used.
Elidel's label now contains a boxed warning, alerting patients about the potential risk of cancer. Elidel, known generically as tacrolimus, is manufactured by Novartis.