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FDA Issues Warnings on Eczema Drugs NewsMax.com WiresWASHINGTON - 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. Story Continues Below 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. 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.
No Clinical Relationship
No clinical relationship has been established between use of the cream and development of cancer, Novartis said. 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.
© 2005 Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten or redistributed. Editor's note: Read more on this subject in related Hot Topics: |
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