Jan. 19, 2006 -- The FDA has approved the "black box" warning that two prescription eczema drugs will carry.
The FDA announced in March 2005 that two topical eczema drugs -- Elidel cream and Protopic ointment -- would get a "black box" warning about a possible cancer risk. A "black box" warning is the FDA's strongest warning.
An FDA committee had recommended the warning in February 2005. Now, the FDA has approved the warning's content.
The warning states that there have been rare reports of cancer (for example, skin and lymphoma) in patients who had been receiving the two drugs, says an FDA news release. However, the drugs haven't been proven to cause cancer, says the FDA.
The drugs' makers are studying cancer risk, but it could take many years for the results to come back, according to the FDA.
The new warning also states that long-term use of the drugs should be avoided and that the drugs aren't recommended for children younger than age 2.
Drugs Still Have Benefits
While the cancer studies are still being done, "there is a benefit associated with these drugs when used appropriately," states the FDA.
"For instance, they may be effective when other prescription topical medications do not work or are not advisable for the patient," the FDA says.
"The drugs are intended to be used for short periods, but if a patient requires a longer period of treatment, the treatment can be repeated after a period of time off treatment. Patients are advised to call their doctor if symptoms worsen, they develop an infection, or if symptoms do not improve within the six weeks of treatment."
Other drugs should be tried first, says the FDA.
Eczema, or atopic dermatitis, is one of the most common skin disorders seen in infants and children, affecting 10% to 15% of children. Its cause isn't known, but allergy or immune problems may be involved.
"It is not known exactly how the products work, but they have various effects on the body's immune system," states the FDA.
"We are taking steps to ensure that healthcare providers and patients are aware of the possible long-term risks of these products so that they will be used appropriately," says Steven Galson, MD, MPH, in the news release.
Galson directs the FDA's Center for Drug Evaluation and Research.
"Today's actions are aimed at making sure that healthcare providers and consumers understand the new warnings and that it is important that these products be used as recommended in the label," he continues.
Novartis makes Elidel cream and Astellas Pharma Inc. (formerly Fujisawa Healthcare) makes Protopic ointment.