It is on permanent view of mounting evidence to hide the dangers of the psychiatric drug Prozac, the Food and Drug Administration (FDA Foods and Drogs Administration) that has frustrated the movement against anti-depressant that more reports of adverse reactions has any other substance accumulated in the 24 year history of the system of disclosure of adverse reactions to drugs that the FDA published.
According to documents recently obtained by FREEDOM under the magazine under the Freedom of Information Act (FOIA, Freedom of Information Act), in date of September 16, 1993, there were 28,623 reports of adverse reactions to Prozac have been received by the FDA. These included effects such as delirium, hallucinations, convulsions, violent hostility, aggression, psychosis, 1,885 suicide attempts and 1,734 deaths of which 1089 by suicide.
-27 Deaths during clinical trials
Additional documents obtained under the Freedom of Information Act reveal that the multinational Eli Lilly & Co., maker of Prozac, and FDA officials were aware that at least 27 deaths were related to the use of Prozac before that the drug was marketed.
One document shows that on 15 October 1987, two months before Prozac was approved for the market, and there had been 15 suicides related to it (six by overdose, four guns, three by hanging and two asphyxiated). It also describes a total of 12 other deaths in the document provided by Lilly to the FDA.
Despite the alarming information on these 27 fatalities (a substance was withdrawn from the market (1) with only two deaths), FDA officials did not stop the Prozac was released. Instead, Procera AVH it was given final approval by the FDA on December 29, 1987.
-The patch of 1986 warned of the dangers of prozac
Another document obtained under the umbrella of the Freedom of Information Act, dated March 23, 1986, is a safety review of Prozac’s FDA Richard Kapit, who noted that “fluoxetine [Prozac] may exacerbate (2) certain depressive symptoms and signs. ”
Kapit, MD noted, “clinical risks of mild to moderate severity are associated with the use of fluoxetine, as determined by a review of safety data according to the NDA (3). These potential risks include” the intensification samples and vegetative symptoms of depression. “(4)
The patch 1986 from FDA also found that Lilly failed to disclose the information about the onset of psychotic episodes in people during the trial of Prozac. However do not take any action against the manufacturer of the drug.
Dr. Kapit concluded his safety review with this warning: “it is suggested that labeling is developed with warnings to physicians about possible exacerbation of vegetative manifestations of depression …. If the drug is marketed, studies should be required post-marketing to more accurately determine the severity of these potential risks. ”
At the beginning of 1986, ie long before Prozac was approved for public consumption, there was evidence linking Prozac with worsening symptoms of depression and the onset of psychotic episodes – a fact underscored by the 1,089 suicides as of September 16, 1993, along with many episodes of irrational violence, murder and even mass murder.
