Elidel Cancer: What a Difference a Decade Makes

Washington, DCWhen Elidel was first brought to market as a treatment for various skin ailments in 2001, everything appeared positive. A now-outdated Elidel TV commercial making the rounds on YouTube is a light-hearted treatment with plenty of friendly faces (including children) and an embracing voiceover expounding the virtues of the non-steroid Elidel Cream. "You can use Elidel for repeated courses as directed by your doctor," the commercial claims.

What a difference a few years makes. Today the Medication Guide, as posted on the manufacturer's Web site, notes that "it is not known if Elidel Cream is safe to use for a long period of time." In fact, under the heading 'What is the most important information I should know about Elidel Cream,' Novartis references the possibility for cancer behind the reference for long-term use.

In the Medication Guide, posted online on the Novartis Web site, it is noted that while a 'small number' of people have acquired cancers such as skin cancer or lymphoma, a causal link between Elidel and cancer incidence has not been shown.

But there was no mention of any of that in the 2003 television commercial.

The US Food and Drug Administration (FDA) has since mandated a black box warning for Elidel. And because of the potential for Elidel side effects—including Elidel cancer—the FDA recommends that Elidel (pimecrolimus) be avoided as a first line of defense for mild to moderate atopic dermatitis (a form of eczema).

"Elidel Cream should not be the first prescription treatment that you try to treat your atopic dermatitis. Use Elidel Cream only after other prescription treatments did not work or if other prescription treatments are not right for you," states a release posted by the FDA on its official Web site.

As for the potential for cancer, the FDA summarizes the risk this way:

"As noted in the Elidel Cream label and patient Medication Guide, although a link has not been made, rare cases of cancer (for example, skin and lymphoma) have been reported in patients who use Elidel Cream. The manufacturer is conducting studies to examine the risk of cancer. These studies may take many years to complete."

Elidel skin cancer, given its absence in the 2003 Elidel television advertising, appears to have been an unexpected adverse reaction that escaped notice when Elidel was first brought to market. That begs the question as to why the potential for cancer was not identified as a risk or potentiality during the pre-approval stage for Elidel, when clinical trials help determine the safety and efficacy of a drug.

The FDA has always been governed by the philosophy that so long as the benefits of a drug outweigh the risks, it remains acceptable to keep a drug on the market in the interests of those who benefit from a drug. In the case of Elidel skin cream, those benefits in relation to risk have become clouded over time.