Protests lodged against black box warnings on newer atopic dermatitis drugs

February 10, 2006

The American Academy of Dermatology (AAD) and the National Jewish Medical and Research Center (NJMRC) have issued statements protesting new black box cancer warnings that the US Food and Drug Administration (FDA) has ordered on Elidel Cream (pimecrolimus; Novartis) and Protopic ointment (tacrolimus; Astellas Pharma US, Inc.), both use to treat atopic dermatitis (eczema).

The American Academy of Dermatology (AAD) and the National Jewish Medical and Research Center (NJMRC) have issued statements protesting new black box cancer warnings that the US Food and Drug Administration (FDA) has ordered on Elidel Cream (pimecrolimus; Novartis) and Protopic ointment (tacrolimus; Astellas Pharma US, Inc.), both use to treat atopic dermatitis (eczema).

The black box warning states that there have been reports of skin cancer and lymphoma in patients who have taken the drugs, according to an FDA news release; an FDA report states that while a causal link between the drugs and cancer has not been established, rare cases of cancer have been reported in patients who have taken them. The FDA also plans to issue a medication guide to alert users.

During a 2005 AAD conference with dermatologists, patients, pharmacists, and immunologists to review research and safety data for the two drugs, the consensus of the attendees was that the black box warning was unwarranted and could limit access to the drugs or treatment options if patients were fearful of using them.

"The AAD is very disappointed with the ruling by the FDA, since we do not think that the science supports this harsh labeling," said AAD spokeswoman Abby Van Voorhees, MD, head of the University of Pennsylvania Health System's Psoriasis and Phototherapy Treatment Center. "The link to cancer was not proven, and the data shows these medications to be quite safe.

"We are concerned that eczema patients and their doctors are going to be frightened by the warning, and therefore patients might not get the medications they need due to unwarranted fear. We would hate to see patients inadequately treated as a consequence."

The NJMRC issued a statement saying that its several-year study concluded that the drugs are safe and offer fewer harmful side effects than other products used to treat atopic dermatitis.