FDA Public Health Advisory March 10, 2005
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.