January 23rd, 2006

Cancer and Lymphoma Warnings on two Eczema Drugs

Elidel Cream

The FDA found two common eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus), have a possible risk for skin cancer and lymphoma. New warning labels are being added to the boxes of these medications to warn patients.

There has not been a concrete direct link for causing cancer; however there have been 78 cancer reports to the FDA with patients that have used these drugs. The FDA’s Pediatric Drugs Advisory Committee wanted this warning put on packaging a year ago. This was followed a month later with the FDA issuing a Public Health Advisory letting physicians know of the possible risk.

This printed black-box warning says that the long-term safety of these drugs are not determined at this time. It also says that these drugs should be a second-line therapy for short-term treatment when other treatments have not worked. The FDA said a second course of these drugs can be used again if “after a period of time off treatment.”

Both manufacturers of these drugs are conducting studies to insure that they are safe. The drug manufacturers want to show that the claims are by the FDA are not warranted. In the mean time both companies have complied with the FDA. There needs to be research on whether it causes cancer or not. Between the two drugs there have been approximately 10 million people that have used these eczema treatments.

Eczema is sometimes called dermatitis and it can affect all age groups. Children will be affected around one-fifth of the time, when adults are affected around one in twelve people. Skin can vary from a mild dry, hot and itchy feeling, to a severe form when the skin becomes broken, raw, and bleeding. Eczema is not contagious and treatment can reduce the inflammation and discomfort associated with this disorder.