FDA cautions doctors on use of drugs for eczema
Thursday, March 10th 2005, 2:56 pm
By: News On 6
WASHINGTON (AP) _ 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 said in its advisory.
The FDA said the manufacturers of the products have agreed to do further tests to determine the actual risk.
The agency said it is developing a medication guide for patients. It urged physicians considering prescribing the drugs to consider the following:
_ Elidel and Protopic are approved only for short-term and intermittent treatment of eczema in patients who don't respond to or cannot tolerate other treatments.
_ These drugs are not approved for use in children younger than 2 years old because the long-term effect on the developing immune system is not known. In clinical trials, infants and children younger than 2 years of age treated with Elidel had a higher rate of upper respiratory infections than those treated with placebo cream.
_ These drugs should not be used continuously. The long term safety of these products is unknown.
_ Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.
_ Use the minimum amount needed to control symptoms. The animal data suggest that the risk of cancer increases with increased exposure.