FDA Toughens Warnings for Two Prescription Eczema Drugs

MAY 01, 2005
Ken Rankin

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.