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Eli Lilly Hides the Implications of Prozac-Induced Mania

Eli Lilly Hides the Implications of Prozac-Induced Mania [Pg.384]

Even in the short clinical trials for the NDA, Prozac caused mania in slightly more than 1% of patients (Kapit, 1986c). But material that I turned up in the NDA indicates that Prozac poses a considerably greater danger of causing mania than the tricyclic antidepressants (Kapit, 1986c). In studies used for FDA approval, only 0.3% of patients on tricyclics became manic—a rate one-third that of Prozac. In addition, all the patients who became manic on tricyclics turned out to have a prior history of mania. Among the 33 reported cases of mania on Prozac, 23 occurred in patients who had never been manic before. [Pg.384]

Mania frequently results in very destructive behavior toward oneself or others, including outright violence (chapter 6 Breggin et al., 1994a especially Breggin, in press). Untold numbers of lives have been ruined by antidepressant-induced mania. The manic person can experience intense paranoid feelings and often feels enormous hostility, especially if thwarted in his or her own ambitions of the moment. The increased rates on Prozac once again confirm its stimulant quality. [Pg.384]

As mentioned in chapter 7, the totals for Prozac stimulation should have been even higher, however, because Beasley did not count several categories of overstimulation, including euphoria, mania, and hyperactivity. The rates of agitation would also have been higher if a large percentage of the Prozac patients had not been prescribed concomitant benzodiazepines and other sedatives. [Pg.385]

In going through mountains of documents, I found no evidence that the FDA ever saw the crucial Beasley study that confirmed FDA investigator Kapit s frequently expressed concerns about the drug s similarity to stimulants, including amphetamine (e.g., Kapit, 1986c). [Pg.385]




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