Adverse Reactions to Prozac in Eli Lillys Earliest Research

Adverse Reactions to Prozac in Eli Lilly s Earliest Research 

In the March 1986 safety review of the NDA (Kapit, 1986b), the FDA psychiatrist summarized five serious clinical events in the first 77 patients given Prozac, including 1 with paranoid psychosis and 1 with manic psychosis. There was also evidence in Eli Lilly s files—presented in my testimony—that some of the first human subjects responded very adversely to Prozac. In his deposition, Eli Lilly s top scientist, Ray Fuller (1994), confirmed the existence of an early in-house memo, in which he wrote  

Some patients have converted from severe depression to agitation within a few days. In one case the agitation was marked and the patient 

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