The U.S. Food and Drug Administration on Thursday recommended that the two eczema medications, Elidel and Protopic, should carry a strong advisory about a cancer risk. The agency is working on a "black box" warning for the salves -- the strongest warning carried on medicines.

The Research revealed the medications are absorbed into the body and may have the potential to cause cancer.

The agency feels that babies should not be treated with the creams at all.
The FDA cited the tests of whether an agent can cause cancer are done on animals, because it would be unethical to experiment on humans.

Novartis AG, the maker of Elidel, disputed the FDA's call for a black box warning and declared there would be no change in its label for the time being. Protopic is Fujisawa Healthcare Inc. product.

The company stated, "We are working closely with FDA to revise Elidel prescribing information to ensure that physicians and patients have the information they need to effectively treat eczema,"

FDA has informed Novartis that we would begin discussions about the type of label and the exact wording contained in the label within the next few weeks.

There is no change in the label for time being.

The company spoke out, "Novartis agrees that patients suffering from mild-to-moderate eczema need to be informed about the safe and effective use of Elidel, but we believe a recommendation to add a black box warning to the label is unsubstantiated by clinical evidence and experience in more than five million patients worldwide."