Eczema Drugs: Warning Upsets Doctors
Dermatologists' Group Objects to FDA's 'Black Box' Warning on Elidel and Protopic
WebMD News Archive
Jan. 26, 2006 - The FDA's "black box" cancer warning on two eczema drugs is bogus, the American Academy of Dermatology says.
The Elidel and Protopic. The warning states that while "a causal relationship" is not proved, there have been rare cases of skin cancer and lymphoma among patients taking these drugs.
that it would require its strongest safety warning -- the "black box" -- on two eczema creams,
In a highly unusual step, a major medical organization -- the American Academy of Dermatology -- is protesting the FDA action.
"The AAD is very disappointed with this ruling by the FDA," AAD spokeswoman Abby Van Voorhees, MD, tells WebMD. "We don't think the science supports this harsh labeling. The link to cancer was not proven, and the data shows these medications to be quite safe."
Eczema patients -- and their doctors -- are going to be frightened by the warning, says Van Voorhees, assistant professor and director of the psoriasis and phototherapy treatment center at the University of Pennsylvania.
"Eczema patients have a lot of pain and suffering, and we worry they might not get these medicines due to unwarranted fear," she says. "This is a medication that can be very helpful for patients. We would hate to see them be inadequately treated as a consequence."
Novartis, which makes Elidel, will fully comply with the FDA's ruling. But in an unusual move -- drug companies don't like to anger the FDA -- the company is publicly critical of the agency's action.
"We want to make it very, very clear that this action is not substantiated by scientific or clinical evidence," Novartis spokeswoman Megan Humphrey tells WebMD. "Based on 21,000 patients in clinical trials, and based on postmarketing use of Elidel in more than 6 million patients, there is no evidence of a causal relationship between Elidel and cancer."
FDA spokeswoman Crystal Rice says the FDA is merely warning that nobody knows whether the long-term use of Elidel and Protopic is safe.
"We acknowledge that there are different approaches and differences of opinion, but in the end, the major finding FDA wanted to convey was the report of cancer cases in patients," Rice says.
The FDA action was prompted by its Pediatric Advisory Committee. This group of independent experts in February 2005 voted 15-1 to recommend the black box warning.
P. Joan Chesney, MD, of St. Jude Children's Research Hospital in Memphis, Tenn., chaired the advisory panel. She declined to be interviewed for this article. However, she spoke to the issue at the February 2005 panel meeting. Verbatim transcripts of FDA advisory panel meetings appear on the FDA web site.
"There is a risk to long-term use [of Elidel and Protopic]," Chesney said in summing up the panel's deliberations. "There should be increased emphasis on use of the product only as second-line therapy because of the potential risk. ... Use in children under 2 years of age should be minimized, again because of unknown risk. ... It should not be used in immunosuppressed patients or those with an increased risk for cancer [because the drugs' immune-suppressing effects] in some cases may result in cancer."