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March 11, 2005
Fujisawa Healthcare Inc. released a letter it sent to physicians February 24 saying it did not have any research indicating an increase in the rate of cancerous Protopic side effects of lymphoma or skin cancer. Protopic is the company’s eczema cream that was FDA approved in 2000.
Although Fujisawa said it had not found any data clearly linking Protopic side effects to cancer, the FDA has issued Protopic side effects warnings after animal studies have shown that three different species of animals developed cancer following exposure to the drug that was applied topically or given by mouth. The FDA has ordered a “black box” warning be placed on the drug’s labeling warning of the possible Protopic side effects.
The company has agreed to do more tests to determine the actual cancerous Protopic side effects risks, according to the FDA.
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