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Eczema Drugs: Warning Upsets Doctors

Dermatologists' Group Objects to FDA's 'Black Box' Warning on Elidel and Protopic

FDA Perspective continued...

Van Voorhees argues that there is very little evidence that either Elidel or Protopic has caused any cancers. The fact that the drugs' long-term risk is unknown, she says, is not enough reason to discourage their use.

"There are unknown risks with any medicine that is fairly new on the market," Van Voorhees says. "But currently there is really no evidence demonstrating that cancer was caused by Elidel or Protopic -- even in the rare cases among people using these drugs. Providing information about a theoretical concern is important. But we don't feel placing a black box warning on the label was the best way to do it."

Inappropriate Use or Good Clinical Practice?

Panel member Norman Fost, MD, MPH, is professor of pediatrics at the University of Wisconsin, Madison. He said during the panel discussion that he was alarmed at how many Elidel and Protopic prescriptions were being written as first-line treatments or for children under the age of 2 years.

"A black box warning may be excessive, may be overshoot, may be unduly inhibiting [to patients who need the drugs]," Fost said. "[But] it may be that's the only tool left to stop millions of prescriptions that are inappropriate. ... That may be the only way to do it."

Van Voorhees says that doctors have to be able to treat patients as best they can. Sometimes, she says, this means using drugs in ways that aren't yet officially approved. Such "off-label use" is common for a wide variety of medicines.

"It is very nice when caring for patients to have as many drugs at your disposal as possible," Van Voorhees says. "Rulings that limit the number of drugs that patients can access is not very helpful to doctors on the front line of caring for patients."

The FDA, she says, has made it clear that it would like to see Elidel and Protopic reserved only for patients for whom conventional steroidal medications don't work. And the FDA would prefer to see the drug prescribed only for short-term treatment. But there are real-world reasons to use the drugs in these ways, Van Voorhees says.

"There are specific situations, based on medical problems or locations of rash, that could make first-line treatment with Elidel or Protopic very appropriate," she says. "And the FDA is trying to encourage people to use these drugs for a shorter period. That can be very challenging, because eczema is painful and itchy and long lasting. We want to be able to maintain patients' skin with good rash control over a long time."


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