Fluoxetine, known under the trade names Prozac, Sarafem, Ladose and Fontex, among others (about 175), created in 1974, is an antidepressant of a class of drugs called selective serotonin reuptake inhibitors (SSRIs). It was one of the first therapies in its class used to treat what people called clinical depression. It theoretically blocks the uptake of serotonin within the human brain.

Prozac might temporarily relieve the symptoms but that is “secondary”. Illness is the exception and not the rule. Sick people represent a relatively small market. [1] John Virapen wrote, “Imagine if you could talk those who aren’t ill into taking pills.” Then you would reach a new dimension of marketing. That “was exactly the role Fluoxetine was supposed to play.” [2]

By 1984, Eli Lilly, a pharmaceutical company based in Indianapolis, was well aware of the serious issues with Prozac, long before the company introduced it to the American market. Statistics in an internal Lilly document show that akathisia, a severe agitation that often provokes suicide, occurs in at least one percent of all patients. Lilly lists akathisia in its product literature deigned for the United States, but only as an infrequent event for Prozac users and fails to mention akathisia and its relationship to suicide.

On May 25, 1984, Barbara von Keitz, an Eli Lilly employee in Hamburg sent a document to Lilly headquarters in Indianapolis, regarding fluoxetine (Prozac). Keitz, in referring to the fluoxetine studies conducted by Eli Lilly, stated that fluoxetine compared to standard antidepressants and placebo was ineffective. Keitz pointed out that there were sixteen suicide attempts during the treatment with fluoxetine, two of which were successful. This was after Lilly excluded anyone who was at risk for suicide from the studies. Keitz suggested that the suicides could probably be “attributed” to the drug. She pointed out that the number of patients was too small and many of the studies were incomplete as patients dropped out due to the high incidence of adverse side effects. [3]

On March 23, 1985, Dr. Richard Kapit, after his safety review of fluoxetine, said in an internal FDA document that there were seventy-six “significant” adverse events occurring among patients exposed to fluoxetine in the clinical trials. Some of the side effects included hypersensitivity, psychotic episodes, and a decrease in hemoglobin level. Most frequently, this drug caused nausea, insomnia, nervousness, diarrhea, and a reduced appetite and weight loss. Other adverse reactions experienced during the trials included seizures, paranoia, severe dystonic reaction, scaly rash, mania, suicide, attempted suicide, and movement disorders such as dyskinectic jaw movements, involuntary movements of the face and arms, vaginal bleeding and allergic skin reactions requiring hospitalization. [4]

Kapit, the FDA psychiatrist in charge of evaluating the safety of Prozac, then writes, “Unlike standard tricyclic antidepressants, fluoxetine’s profile of adverse effects more closely resembles that of a stimulant drug than one that causes sedation and gain of weight…Indeed nervousness was the most common adverse symptom cited by long-term fluoxetine patients who eventually discontinued therapy due to an adverse reaction.” Dr. Kapit said, “If the drug is marketed, post marketing studies should be required to determine the frequency with which fluoxetine may cause intensification of these specific signs and symptoms of depressive illness.” [5]

In the clinical trials, Prozac caused mania in one in 100 people which would be much higher in unobserved patients in daily life. One in 100, considered common, poses an incredible risk to public safety. Dr. Breggin states, “Seventy percent of the patients who became manic on Prozac had never shown any signs of manic tendencies in the past.” [6]

On October 10, 1985, the Psychopharmacologic Drugs Advisory Committee (PDAC) convened a two-day public hearing to determine the efficacy of Prozac (on the first day) and Haloperidol (on the second day). The composition of the committee did not meet the FDA criteria in that there were seven employees of Eli Lilly who participated. Dr. Paul Leber, in behalf of the FDA, concluded that fluoxetine was a “reasonably safe antidepressant” but the FDA had not recommended that the FDA approve of the drug as the agency was still waiting for “evidence to be submitted regarding the dose-response relationship and the labeling of the product, a final safety update, and other matters that are yet to be determined.” [7]

Lilly knew Prozac’s stimulating effects, due to the clinical trials, before the company marketed the drug. Charles M. Beasley, a Lilly executive, compiled a secret report, Activation and Sedation in Fluoxetine Clinical Studies. He totaled the number of patients who exhibited “nervousness, anxiety, agitation, insomnia.” He discovered that thirty-eight percent of them experienced these adverse effects during the brief clinical trials. He did not include hyperactivity, euphoria, and mania. Lilly never revealed the results of Beasley’s report to the FDA or any other entity. [8]

Dr. Ray W. Fuller issued the following in-house secret order, “Some patients have converted from severe depression to agitation within a few days (of starting Prozac). In one case, the agitation was marked and the patient had to be taken off the drug. In future studies, the use of benzodiazepines (tranquilizers) to control agitation will be permitted.” The FDA prohibits the use of tranquilizers in conjunction with Prozac in the clinical trials. The addictive tranquilizers, only to be taken for a brief period, masked Prozac’s propensity to cause stimulation. [9]

In 1962, the law stated that the FDA should not approve of a drug if “there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have, under the conditions of use prescribed, recommended or suggested in the proposed labeling.” it is, “we shouldn’t approve it.” [10] Dr. Robert S. Mendelsohn wrote, “It doesn’t make much sense to buy a drug when the manufacturer can’t prove that it works.” [11]

Research in the late 1980s, conducted by Eli Lilly confirmed that Prozac may cause suicide. Yet, many doctors prescribed it to their patients supposedly to prevent depression and suicide. Lilly evaluated its clinical trials, which they claim involved more than three thousand patients. They published their results in the British Medical Journal (BMJ) alleging that there was no increased suicide risk. Yet, even within the article, it states that there were six suicides out of 1,765 patients on Prozac as opposed to one in the 569 patients on placebo. [12]

In 1986, in the clinical trials, 12.5 patients out of 1,000 who were taking Prozac committed suicide as compared to only 3.8 patients who were taking the non-SSRI antidepressants and 2.5 patients who were taking a placebo. In 1995, in another trial for Prozac, the suicide rate would be six times higher. Package inserts mention suicide, but not all of the other possible adverse reactions. Suicide was not on the insert for years even though Eli Lilly knew of the risk. [13]

Eventually, the FDA found out about Eli Lilly’s deadly deceptions. Because the company had spent millions of dollars, it would be a “financial catastrophe” if the FDA failed to approve of Prozac, which was ineffective, without the use of a tranquilizer. The FDA, to rescue Eli Lilly, included those trials where the patients used tranquilizers and manipulated the statistical data regarding the drug’s effectiveness and “Prozac squeaked through.” Though the FDA approved of Prozac, when used with addictive tranquilizers, no one informed the medical profession, the unsuspecting potential patients or the public. [14]

Incredibly, the FDA approved of Prozac using only three cherry-picked favorable protocols, involving seventeen studies and several hundred patients. Dr. Breggin thoroughly examined each of the seventeen studies to determine exactly how many Prozac patients actually finished the four, five, or six-week trials. The total number of patients was a paltry 286 patients. Out of the thousands who initially offered to participate in the clinical trials, less than 300 patients completed the trial. Based on the conclusions of the predisposed questions of the doctors monitoring those patients, the FDA approved Prozac on December 29, 1987 for treating depression. The FDA provided its Summary of Basis of Approval of Prozac on October 3, 1988 using the fourteen protocols involving Lilly’s submitted controlled studies. Anyone taking Prozac, for more than a few weeks is actually participating in a continuous clinical trial due to the failure of the FDA to require legitimate, reasonably-timed trials that actually test long-term usage, effectiveness and safety. [15]

[1] John Virapen, Side Effects Death, Confessions of a Pharma-Insider, Virtualbookworm.com Publishing Inc., College Station, Texas, 2010, p. iv

[2] John Virapen, Side Effects Death, Confessions of a Pharma-Insider, Virtualbookworm.com Publishing Inc., College Station, Texas, 2010, p. 73

[3] PDAC Regarding the Results of FDA’s Ongoing Meta-analysis of Suicidality Data from Adult Antidepressant Trials, Psychopharmacologic Drugs Advisory Committee (PDAC) members, December 1, 2006, For: December 13, 2006, Various documents used to represent 100 individuals in suicide and suicide attempt cases involving SSRI antidepressants, including Paxil, Zoloft and Prozac, http://www.baumhedlundlaw.com/safety-advocates/bhlaw-ssridocs.php, viewed 8/14/2014

[4] PDAC Regarding the Results of FDA’s Ongoing Meta-analysis of Suicidality Data from Adult Antidepressant Trials, Psychopharmacologic Drugs Advisory Committee (PDAC) members, December 1, 2006, For: December 13, 2006, Various documents used to represent 100 individuals in suicide and suicide attempt cases involving SSRI antidepressants, including Paxil, Zoloft and Prozac, http://www.baumhedlundlaw.com/safety-advocates/bhlaw-ssridocs.php, viewed 8/14/2014

[5] PDAC Regarding the Results of FDA’s Ongoing Meta-analysis of Suicidality Data from Adult Antidepressant Trials, Psychopharmacologic Drugs Advisory Committee (PDAC) members, December 1, 2006, For: December 13, 2006, Various documents used to represent 100 individuals in suicide and suicide attempt cases involving SSRI antidepressants, including Paxil, Zoloft and Prozac, http://www.baumhedlundlaw.com/safety-advocates/bhlaw-ssridocs.php, viewed 8/14/2014

[6] Peter Breggin, The Antidepressant Fact Book: What Your Doctor Won’t Tell You About Prozac, Zoloft, Paxil, Celexa, And Luvox, Da Capo Press, Cambridge, Massachusetts, Kindle, 2009, Locations 783-786, 793-799

[7] Psychopharmacologic Drugs Advisory Committee, Twenty-eighth Meeting, Volume 1, October 10, 1985, http://www.healyprozac.com/PDAC/PDAC-Prozac. Oct 1985.pdf, viewed 8/12/2014

[8] Peter Breggin, The Antidepressant Fact Book: What Your Doctor Won’t Tell You About Prozac, Zoloft, Paxil, Celexa, And Luvox, Da Capo Press, Cambridge, Massachusetts, Kindle, 2009, Locations 856-870

[9] Peter Breggin, The Antidepressant Fact Book: What Your Doctor Won’t Tell You About Prozac, Zoloft, Paxil, Celexa, And Luvox, Da Capo Press, Cambridge, Massachusetts, Kindle, 2009, Locations 871-880

[10] Psychopharmacologic Drugs Advisory Committee, Twenty-eighth Meeting, Volume 1, October 10, 1985, http://www.healyprozac.com/PDAC/PDAC-Prozac. Oct 1985.pdf, viewed 8/12/2014

[11] Robert S. Mendelsohn, MD, How to Raise a Healthy Child in Spite of your Doctor, Ballantine Books, New York, 1984, p. 115

[12] David Healy, Pharmageddon, University of California Press, Berkeley, Los Angeles, Kindle, 2012, pp. 210-213

[13] Leah R. Garnett, Prozac Revisited: As Drug Gets Remade, Concerns about Suicides Surface, May 7, 2000, http://antidepressantadversereactions.com/articles/boston_globe_050700.php, viewed 8/13/2014

[14] Peter Breggin, The Antidepressant Fact Book: What Your Doctor Won’t Tell You About Prozac, Zoloft, Paxil, Celexa, And Luvox, Da Capo Press, Cambridge, Massachusetts, Kindle, 2009, Locations 884-893

[15] Peter R. Breggin, Ginger Ross Breggin, Talking Back to Prozac: What Doctors Won’t Tell You about Prozac and the Newer Antidepressants, Open Road Media, New York, Kindle, 2014, Locations 1071-1077