There is an approval of updated labeling for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus).
The labeling will be updated with a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling) will be distributed to help ensure that patients using these prescription medicines are aware of this concern.
The new labeling also clarifies that these drugs are recommended for use as second-line treatments. This means that other prescription topical medicines should be tried first.
Use of these drugs in children under 2 years of age is not recommended.
Eczema or atopic dermatitis is one of the most common skin disorders seen in infants and children, affecting 10 to 15 percent of the childhood population.
Although the cause of atopic dermatitis is not known, it is thought that there may be an allergic or immune mediated component.
Patients have chronic itching and dry skin, which results in redness and damage to the skin due to rubbing and scratching.
Both products 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.
“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”, said Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research (CDER).
The Medication Guide will provide consumer friendly information to patients about how to use the drugs safely. Pharmacists are required to provide the Medication Guide to patients when dispensing the drug. Patients are advised to read the entire Medication Guide and talk to their healthcare provider if they have further questions.
Novartis manufactures Elidel cream and Astellas Pharma, Inc (formerly Fujisawa Healthcare) is the manufacturer of Protopic ointment.