Eli Lilly Knew From the Start That Prozac Acts Like a Stimulant

Eli Lilly Knew From the Start That Prozac Acts Like a Stimulant 

After all the data had been collected during Prozac s new drug application (NDA)1 approval process, FDA psychiatrist Richard Kapit (1986b) wrote the official safety review of adverse reactions or side effects. Kapit 

It is possible that these adverse effects of fluoxetine treatment may negatively affect patients with depression. Since depressed patients frequently suffer from insomnia, nervousness, anorexia, and weight loss, it is possible that fluoxetine treatment might, at least temporarily, make their illness worse. 

Kapit repeated this concern in his summary, stating, It is possible, therefore, that fluoxetine may exacerbate certain depressive symptoms and signs. He recommended that the label warn physicians about these dangers. 

in his safety update of the NDA on October 17, 1986, Kapit spoke of several cases of a syndrome of fluoxetine-induced hyper-arousal and excessive stimulation... [that] resemble episodes of stimulant drug intoxication. It was especially likely to occur at higher doses, but it could occur at the standard 20 mgs. The state of overstimulation included anxiety, agitation, insomnia, headache, confusion, dizziness, obnubilation [mental clouding], memory dysfunction, tremor, impaired motor coordination. Hyperactivity, hypomania, and mania may sometimes occur. In overdose, the drug produces an even more flagrant stimulant syndrome culminating in seizures. Thus there is a continuum of stimulation effects. 

---