When Eli Lilly applied for a license to sell Prozac in Germany in 1984, the German authorities became very concerned.
During treatment, 16 of the patients on Prozac therapy made suicide attempts with 2 of the attempts being successful. In Germany, a suicide warning must be on the Prozac labeling. The label also requires that the patient is observed sufficiently until the antidepressant effects of Prozac sets in and that the patient may need an additional sedative in the meantime.
According to lawyers representing patients who have taken Prozac, over 45,000 reports have been filed to the FDA, including 2500 concerning wrongful death by suicide or violence caused by severe agitation induced by Prozac. The FDA did investigate these allegations in 1991, but released a report stating that there was no correlation between Prozac and the severe agitation that caused suicidal or homicidal behavior.
The report did recommend that more research be done and that patients put on SSRIs be monitored carefully until the antidepressant effects of the medication set in. That was over ten years ago. The FDA has not released any further reports.