WASHINGTON, Jan. 19 (Xinhuanet) -- Two prescription creams to treat eczema will have to carry "black box" warnings about possible cancer risks, the U.S. Food and Drug Administration (FDA) said Thursday.
The FDA action, in accordance with its advisory committee recommendation last February, affects Novartis AG's Elidel and Astellas Pharma Inc.'s Protopic. "Black box" warning is the strongest type used in the United States.
The new labels are also required to clarify that both treatments are recommended for use only after other prescription topical medicines have been tried first.
The FDA decision is based on reports of cancers, including skin cancer and lymphoma, in patients using the two drugs. There had been reports of 78 cases as of last October. However, no evidence has yet established a clear link between the drugs and human cancer risk.
Novartis and Astellas continued to defend the safety of their products, but agreed to make the requested changes in labelling. Meanwhile, the companies are conducting long-term safety studies.
FDA said in a statement "Although studies are being conducted by the manufacturers of both drugs to try to answer questions about cancer risk, it could be many years before the research is concluded."
Elidel and Protopic are applied to the skin to control eczema by suppressing the immune system. Eczema is a rash-like inflammation that causes itchy, red skin. It can also be treated with antihistamines, oral and topical steroids and over-the-counter products. Enditem
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