The eczema creams, Novartis and Protopic are about to be added strong warning signs about the possible risk of skin cancer, lymphoma and other cancers. They will be added "black-box" warnings, which are the strongest types used in the United States.

As of October 2005, 78 cancer cases reported using at least one of the products. However, the clear scientific evidence has not been found yet, neither had the long-term safety of these products been established.
Although both manufacturers had denied the accusations, they have agreed to put the warning signs. Besides the cancer warning, the label will include the statement that the drugs should be used only in cases where other treatments failed and that they should not be given to children younger than 2 years old.

Both manufacturers state that their products are safe if used as prescribed and that the causal relationship with lymphoma has not been documented. Long-term safety studies are being conducted for these products but the FDA could not wait for the results before taking action and has labeled the products.