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Protopic

Cancer warning issued over Protopic eczema cream

–March 11, 2005

The FDA has ordered a "black box" warning be placed on a popular skin cream called Protopic used to treat the skin condition eczema because of a possible cancer risk.

Protopic is usually applied topically through a cream, but authorities warn if absorbed it can cause cancer. The drug agency issued a Protopic public health advisory based on information from animal studies.

Fujisawa Pharmaceuticals, the maker of Protopic, said its research indicated no increase in the rates of lymphoma or skin cancer in users of the drug, but the FDA has received reports of lymphoma and skin cancer in children and adults treated with Protopic since its December 2000 approval.

The FDA said the manufacturer has agreed to do more tests to determine the actual cancer risks in Protopic users, but until then, the FDA has recommended use of Protopic in children younger than two years of age be avoided and that it be used only as a second-line agent for short-term and intermittent treatment in adult patients that have been unresponsive or intolerant to other treatments.

Please contact a Protopic Lawyer if you would like more information on your legal rights and options.

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