FDA Toughens Warnings for Two Prescription Eczema Drugs

Pharmacy Times, Volume 0, 0

Patients receiving 2 prescriptioneczema drugs, Elidel (pimecrolimus)and Protopic (tacrolimus), will soon bereceiving an FDA Medication Guidewarning them of potential cancer risksand other dangers associated withthese medications.

The decision to alert patients tothese risks was taken in response to recommendationsfrom an FDA advisorycommittee. Pharmacists and otherhealth care professionals have alreadybeen advised of the agency's concernsthrough a new "black box" warning onthe professional labeling for the 2products, and through letters recommendingthat Elidel and Protopic beprescribed for patients as a last resort—"only after other eczema treatmentshave failed to work."

The FDA's Public Health Advisoryfurther cautioned pharmacists andphysicians that Elidel and Protopicshould only be used for "short-termand intermittent treatment of atopicdermatitis (eczema) in patients unresponsiveto, or intolerant of other treatments," and that they are not approvedfor children under 2 years old.

Mr. Rankin is a freelance medical writer.