Is FDA Playing Politics with Drug Warnings?
March 24, 2005 — -- When LaDonna Williams had to remove every mirror in her house, she knew she was near the end of her rope.
"We had to take out all of the mirrors in our house because my daughter didn't want to see the monster, which was herself, on the other side," says Williams, whose daughter suffers from bleeding skin and itchy red patches caused by eczema.
"It was hard to watch as your kids don't get invited to all the fun activities concerning school, all because of how they looked," said Williams, executive director of the Inflammatory Skin Disease Institute in Newport News, Va.
Help came from two skin creams for eczema, Protopic and Elidel, which were introduced to the public in 2000 and 2001, respectively.
But the Food and Drug Administration recently announced that it will be adding a "black box warning" to the drugs after three animal studies showed they were associated with an increased risk of cancer.
Is the FDA overreacting? Many dermatologists think so -- and so do their patients.
The FDA warning came as an unpleasant surprise to eczema sufferers, many of whom have experienced great relief with the drugs. About 7 million to 8 million prescriptions have been written for Elidel and Protopic.
The FDA has received reports of lymphoma and skin cancer in children and adults treated with Elidel or Protopic. However, the agency has not yet determined whether these cancers exceeded the expected number of illnesses seen in any large group of people.
Several members of the FDA's Pediatric Advisory Committee declined to comment directly on the warning, but the FDA acknowledges that it may take more than 10 years of human studies to determine if the drugs' use is linked to cancer.
The committee initially recommended the warning labels due to concerns over the number of prescriptions for Elidel and Protopic that were being written for children.
Tim Warner, a spokesman for Fujisawa, the manufacturer of Protopic, said that the company would be working with the FDA to update the label's wording and to educate health care practitioners.
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