Elidel and Protopic are applied to the skin to control eczema. (file photo)
BEIJING, Jan. 20 (Xinhuanet) -- The US Food and Drug Administration (FDA) announced Thursday that it will require "black box" warnings of possible cancer risks to be put on the labels of two prescription creams that treat eczema.
A black box warning is the most serious type of warning in prescription drug labeling.
The two drugs concerned are Elidel cream and Protopic ointment. They are applied to the skin to control eczema, a chronic skin disease also known as atopic dermatitis. It is estimated that roughly 10 million people combined have used the two drugs.
The warning will be located lower on the labels of the two drugs than is typical, although a statement higher on the labels will refer to the risk, the FDA said.
The new labeling also will clarify that the two drugs are recommended for use only after other prescription topical medicines have been tried by patients, the FDA said.
As of October, the FDA has received reports of 78 cases of cancers, including skin and lymphoma, in patients treated with the two drugs, said Dr. Stanka Kukich, the acting director of the FDA's dermatologic and dental drug products division.
The manufacturers of the two drugs, Novartis Pharmaceuticals ( Elidel) and Astellas Pharma Inc., have agreed to make the requested changes although they remained confident in the safety and efficacy of their drugs. Enditem
(Agencies)
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