Two popular drugs to treat the skin disorder Eczema will now carry black box warnings due to a possible cancer link.
A 'black box' warning is the strongest in the United States for prescription drugs. Now, the makers of 'Elidel' and 'Protopic' have agreed to add the warning at the urging of the FDA, because some patients using the drugs have reported skin, lymphoma and other cancers, although the cases have been rare.
The FDA said Thursday that more studies are being done, but it could be years until conclusions are found. Eczema is a common skin disorder, particularly in infants and children. Both drugs work to control eczema by suppressing the body's immune system.
Novartis Ag, the maker of 'Elidel' said Thursday it remained confident in the safety of it's product. Astellas Pharma, the maker of 'Protopic' also says its product is safe when used in a manner consistent with its label, and says it will issue a new medication guide for patients.