FDA Cautions Doctors On Eczema Treatment
10/19/2005 5:12:59 PM
The Food and Drug Administration issued an advisory to doctors Thursday urging caution in prescribing two drugs for eczema because of the possibility of cancer. The drugs Elidel and Protopic will receive new label warnings pointing out that an increased risk of cancer may be associated with their use, the agency said.
Elidel and Protopic are applied to the skin to control eczema by suppressing the immune system.
But animal tests have shown an increase in cancer associated with the drugs, and a small number of cancers have been reported in children and adults treated with the drugs, FDA (news - web sites) said in its advisory.
The FDA said the manufacturers of the products have agreed to do further tests to determine the actual risk. Makers of the drugs contended that the products have not been tied to cancer.
Fujisawa Healthcare Inc., maker of Protopic, released a letter it sent to physicians Feb. 24 saying concerns were based on animal studies and that its research indicates no increase in the rates of lymphoma or skin cancer in users of the drug.
Novartis Pharmaceuticals, which makes Elidel, issued a statement saying it agrees that the product should be used as indicated but that adding a strong new warning is not justified.