Cancer Risk from Eczema Creams Forces FDA to Issue “Black Box” Label Warnings
The Food & Drug Administration has issued a Public Health Advisory for users of Elidel® while urging the medication manufacturers to add a “black box” warning to their eczema creams. The FDA’s warning states, “It may take human studies of ten years or longer to determine if use of [the drugs] is linked to cancer.”
The “black box” labeling is for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The FDA action in 2006 to upgrade label warnings to “black box” warnings followed the agency’s recommendation in 2005 that Elidel and Protopic carry cancer risk label warnings.
The order has been disputed by the manufacturers, Novartis, which makes Elidel, and Fujisawa Pharmaceutical, which makes Protopic. However, an FDA advisory panel said it was concerned that the companies were aggressively advertising the medicines to treat infants and others with skin problems that the creams are not approved to treat.
Link To Cancer Is Unavoidable
The FDA’s “black box” ruling for the creams — the strongest warning carried by medicines in the US — said animal studies had shown a potential link with cancer. There have also been multiple reports of cases of lymphoma and skin cancers among children and adults treated with Elidel or Protopic.
Both creams work by suppressing the immune system. Depressing immune activity in this way is known to potentially contribute to cancer.
Physicians were warned to prescribe the drugs only for short-term applications, and to only use the drug if other eczema treatments had failed. Protopic should not be used in children under the age of two, and anyone with a compromised immune system should not use Protopic at all.
The relationship between Elidel and Protopic and cancer is becoming more solid. In the last year there has been a 300 percent increase in reports to the FDA of incidences of malignancies that may be connected to these two drugs.