Patients receiving 2 prescription eczema drugs, Elidel (pimecrolimus) and Protopic (tacrolimus), will soon be receiving an FDA Medication Guide warning them of potential cancer risks and other dangers associated with these medications.
The decision to alert patients to these risks was taken in response to recommendations from an FDA advisory committee. Pharmacists and other health care professionals have already been advised of the agency's concerns through a new "black box" warning on the professional labeling for the 2 products, and through letters recommending that Elidel and Protopic be prescribed for patients as a last resort"only after other eczema treatments have failed to work."
The FDA's Public Health Advisory further cautioned pharmacists and physicians that Elidel and Protopic should only be used for "short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments," and that they are not approved for children under 2 years old.
Mr. Rankin is a freelance medical writer.
The Oncology Care Pharmacist in Health-System Pharmacy
According to the National Cancer Institute, almost 40% of men and women will be given a diagnosis of some form of cancer in their lifetime.
News from the year's biggest meetings
Clinical features with downloadable PDFs