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The FDA directed Roche to state on the drug’s label the following caveat: “Tamiflu has not been proven to have a positive impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian, or pandemic influenza.” An FDA spokesperson told the BMJ, "The clinical trials . . . failed to demonstrate any significant difference in rates of hospitalization, complications, or mortality in patients receiving either Tamiflu or placebo.”