Two topical prescription-only medicines used to treat chronic eczema will receive “black box” warnings of possible cancer risks. The U.S. Food and Drug Administration ordered the labels after an agency advisory committee recommendation.
Elidel cream and Protopic ointment will bear the new warning labels. These two drugs should only be used after all other treatments have failed. The labels will reflect that as well. The FDA says it is a possible long-term risk for cancer.
Novartis Pharmaceuticals is the company that makes Elidel and says it is safe. “While Novartis believes this action is not substantiated by scientific or clinical evidence, Novartis has agreed to make the requested changes,” the company said.