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Public Health Advisory Issued for Elidel® and Prolopic®
According to FDA MedWatch and the U.S. Food and Drug Administration (FDA) Web site (www.fda.org), on March 10, 2005 the FDA issued a public health advisory to inform health care providers and patients about a potential cancer risk from use of Elidel " (pimecrolimus) and Protopic" (tacrolimus), products that are applied to the skin for treatment of atopic dermatitis (ezcema). Elidel cream and Protopic ointment are topical immunosuppressant calcineurin inhibitors and are the only approved drug products in this class.
This concern is based on information from animal studies, case reports in a small number of patients, and how these drugs work. 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. It may take human studies of 10 years or longer to determine if use of Elidel or Protopic is linked to cancer, but in the meantime this risk is uncertain and the FDA advises that Elidel and Protopic be used only as labeled for patients who have failed treatment with other therapies. The FDA recommends health care providers, patients, and caregivers consider the following guidelines:
* 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.
* Use Elidel and Protopic only for short periods of time, not continuously.
* 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.
Protopic was approved in December 2000 and Elidel in December 2001. Since their approval, the 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...