Eczema Patients Concerned Over FDA Rulings

People who know the torture of chronic eczema may have a tough choice ahead of them.
Earlier this year, the Food and Drug Administration ordered two of the most effective eczema drugs on the market, Elidel and Protopic, to carry a "black-box warning," the most serious type of warning in prescription drugs. There have been reports of cancer in 78 patients since the drugs were approved in 2000 and 2001. Animal tests have shown a cancer increase associated with the drugs, as well.
But steroids are the only other treatment available.
"Steroids work great, but they have side effects," said Dr. Maria Hordinsky, a professor and the chairwoman of the dermatology department at the University of Minnesota medical school. Steroids can cause thin and reddened skin, and stretch marks.
And they can cause long-term problems with the body's hormone system, she said, a real concern for children who get eczema.
No one knows what causes eczema, but it often runs in families. Immune cells called T cells work their way into the skin and release chemicals that make the skin itch.
"The skin itches like crazy," Hordinsky said. "People scratch, and then they get into an itch-scratch cycle. They can get staph infections and need antibiotics. So managing it is very important."
That's why both doctors and patients were ecstatic with the introduction of Protopic in 2000 and Elidel in 2001. They both suppress the body's ability to make T cells.
Now, what are all those eczema sufferers to do?
First of all, Hordinsky said, follow the FDA's advice in the black-box warning and try other treatments first, she said. Steroids are available in different concentrations, and they can solve the problem for most people. And those who need Protopic or Elidel should use them only on the problem areas, and should avoid using them long-term.
Last of all, she said, keep in mind that if there is a cancer risk, it's very low. There have been 78 cases of cancer, including skin and lymphoma, among 10 million people who have used the drugs. But no direct connection has been shown. And the animal tests that showed a cancer association were done with very high concentrations, higher than any human would use, she said.
Hordinsky was among the researchers involved in clinical trials of the drugs before they were approved by the FDA, but has no financial ties to the manufacturer, she said.