FDA Orders 'Black Box' Warning for Eczema Drugs, Elidel and Protopic

In an important notification, the Federal Drug Administration (FDA) has announced the approval of updated labeling for two topical eczema drugs, Protopic Ointment (tacrolimus) and Elidel Cream (pimecrolimus).

The new labeling will add a black box warning about a possible cancer risk. The boxed warning lets healthcare professionals know that the long term safety of the drugs is yet to be established.

A Medication Guide (FDA-approved patient labeling) will also be included with the medications in order to “ensure that patients using these prescription medicines are aware of this concern.

The updated labeling clearly states that these drugs are recommended for use as second-line treatments, meaning they should be used only after other prescription topical medicines have been tried.

These drugs are not recommended for use in children under 2 years of age.

"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). "Today’s actions are aimed at making sure that health care providers and consumers understand the new warnings and that it is important that these products be used as recommended in the label."

On February 15, 2005, FDA’s Pediatric Advisory Committee first recommended that the labeling be updated with a boxed warning and a Medication Guide about the possible cancer risk for these topical drugs.

In addition, FDA had issued a Public Health Advisory in March 2005 advising healthcare professionals about the possible cancer risk, and indicated that it would ask the sponsors to update the labeling to address this possible risk.

As stated in today’s release: “Although a causal link has not been established, rare reports of cancer (for example, skin and lymphoma) have been reported in patients who had been receiving these products.”

Currently, studies are being conducted by the manufacturers of both drugs to find out further information about the cancer risk, but it could be several years before the research is concluded.

In the meantime, the FDA says, these drugs can be beneficial to patients when used appropriately. For instance, they may be effective when other prescription topical medications are not an option for patients.

According to the FDA release, 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.”

Pharmacists are required to provide the Medication Guide to patients when filling prescriptions for the drug. Patients are advised to thoroughly read the Medication Guide and discuss any questions they might have with their healthcare provider.

Astellas Pharma, Inc (formerly Fujisawa Healthcare) the manufacturer of Protopic ointment, and Novartis, manufacturer of Elidel cream, said the drugs are safe in interviews and statements Thursday.

"The changes to the label are focused on a potential risk, not on a proven or known risk," said Joyce Rico, a vice president at Astellas.

In a statement, Novartis said that the FDA’s concern about a cancer risk is based on studies that used high doses. Although they agreed to change the labeling, the company believes "this action is not substantiated by scientific or clinical evidence."

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