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FDA Public Health Advisory
Elidel (pimecrolimus) Cream and Protopic (tacrolimus) Ointment

The FDA is issuing a public health advisory to inform healthcare providers and patients about a potential cancer risk from use of Elidel (pimecrolimus) and Protopic (tacrolimus), products that are applied to the skin. This concern is based on information from animal studies, case reports in a small number of patients, and how these drugs work. It may take human studies of ten years or longer to determine if use of Elidel or Protopic is linked to cancer. In the meantime, this risk is uncertain and FDA advises that Elidel and Protopic should be used only as labeled, for patients who have failed treatment with other therapies.

The FDA recommends that healthcare providers, patients and caregivers consider the following:

Use Elidel and Protopic only as second-line agents for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments.

Avoid use of Elidel and Protopic in children younger than 2 years of age. The effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical studies, infants and children younger than 2 years old treated with Elidel had a higher rate of upper respiratory infections than did those treated with placebo cream.

Use Elidel and Protopic only for short periods of time, not continuously. The long term safety of Elidel and Protopic are unknown.

Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.

Use the minimum amount of Elidel or Protopic needed to control the patient’s symptoms. In animals, increasing the dose resulted in higher rates of cancer.

Elidel cream and Protopic ointment are topical immunosuppressant calcineurin inhibitors that are applied to the skin and are the only approved drug products in this class.

Animal studies have shown that three different species of animals developed cancer following exposure to these drugs applied topically or given by mouth, including mice, rats and a recent study of monkeys. These studies were conducted at doses higher than generally used by patients and the risk of cancer increased with increasing drug dose and duration.

In addition to an ointment, tacrolimus, also comes as a pill or by injection, this form is known as (Prograf). Prograf is approved to prevent liver or kidney transplant rejection. It is known to cause both skin cancers and lymphoma in humans by suppressing the body’s normal immune defenses against cancer. The cancer risk increases with higher doses and longer treatment courses of Prograf. Both Elidel and Protopic are sometimes absorbed through the skin, though usually at very low amounts. Occasionally, children who have been treated with Elidel or Protopic have had high blood levels of these drugs.

Protopic was approved in December 2000 and Elidel in December 2001. Since their approval, FDA has received reports of lymphoma and skin cancer in children and adults treated with Elidel or Protopic; whether the reported cancers are associated with these products has not been clearly established.

Based on the advice of the FDA Pediatric Advisory Committee, which met on February 15, 2005, to review these findings, FDA will require labeling changes for Elidel and Protopic, including the placement of a boxed warning about the potential cancer risk. In addition, FDA will work with the commercial sponsors of the drugs to develop and implement a Medication Guide (MedGuide) to provide this information and instructions about appropriate use of Elidel and Protopic to patients, their families, and caregivers. MedGuides are intended to be distributed by pharmacists with each prescription or refill of a medication.

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