'Black Box' Warning for 2 Eczema Drugs
FDA Approves Content for Warning on Elidel, Protopic Creams
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 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
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
"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.
Patients have chronic itching and dry skin, which results in redness and
skin damage from rubbing and scratching. Elidel and Protopic are applied to the
skin to help control eczema.
"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
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.