By Gary Null, Ph.D. and Martin Feldman, M.D.

Note: The information on this website is not a substitute for
diagnosis and treatment by a qualified, licensed professional.

Nearly a decade has passed since Prozac, the antidepressant drug, was introduced to the market and quickly achieved the label of a "wonder drug." During that time, Prozac has indeed helped many people who suffer from severe depression. But the early claims that Prozac would alleviate depression without causing harmful side effects have not been realized.

Indeed, just the opposite has proven to be true. Prozac has produced serious side effects in some users, prompting a host of lawsuits against Eli Lilly & Co., the drug's manufacturer.¹ These adverse effects include akathisia (a condition in which a person feels compelled to move about), permanent neurological damage, and suicidal obsession and acts of violence.

In 1990, the Citizens Commission on Human Rights (CCHR), a Scientology organization that investigates psychiatric violations of human rights, wrote a letter to the House of Representatives in which it stated, "The wide use of Prozac has been largely generated by Lilly's false claim that Prozac has fewer side effects than other antidepressant drugs. This is a serious misrepresentation to the public which is destroying lives."²

The letter notes that Eli Lilly changed its advertisements to remove the statement that Prozac causes "fewer side effects." In one ad, for example, the manufacturer said instead that the drug produces "fewer tricyclic-like side effects." However, the CCHR believes Prozac should be recalled. The letter concludes, "...the drug should be immediately recalled as a serious health hazard, and kept off the market until the manufacturer can guarantee that the drug will not kill more people."

A 1990 article in Trial, published by the Association of Trial Lawyers of America, also points to the "dark side" of Prozac, noting that it not only produces troubling side effects but also can be harmful and even deadly when combined with certain other drugs. "Prozac has greatly benefited many severely depressed patients. Others, however, have suffered serious side effects," states the report. "Eli Lilly & Co.'s failure to adequately warn physicians of side effects and of the danger of drug interactions has doubtless resulted in injuries that could otherwise have been avoided. Now that the dangers are better known, doctors should inform patients of these risks."³

THE SIDE EFFECTS OF PROZAC

The CCHR letter notes that the Food and Drug Administration (FDA) received almost twice as many adverse reaction reports on Prozac in two years than it did on Elavil, another antidepressant, in 20 years. Even Valium, a widely used prescription drug, accumulated fewer adverse reaction reports in 20 years than Prozac did in two years, says the CCHR.⁴

Prozac relieves depression by affecting the level of serotonin, a neurotransmitter that connects receptor sites and fires nerve cells. The CCHR letter states that the drug's chemical structure, which is unlike that of other medications, makes it "an utter wild card" in predicting what effects it may have.⁵ And yet, doctors not only prescribe Prozac for depression, its approved use, but also for smoking cessation, weight loss and other problems.

The adverse effects of Prozac can be traced to the drug's effect on brain chemistry. As Peter R. Breggin, M.D., explains in Talking Back to Prozac: What Doctors Aren't Telling You About Today's Most Controversial Drug, Prozac acts as a stimulant to the nervous system.⁶ Therefore, it can produce side effects that mimic those of amphetamines and are exaggerations of the desired effects of Prozac in relieving depression.

According to Dr. Breggin, the FDA psychiatrist who wrote the agency's safety review of Prozac stated that the drug's effects--including nausea, insomnia and nervousness--resembled the profile of a stimulant drug, rather than a sedative.⁷ Dr. Breggin adds that nearly all of the side effects of Prozac listed in the Physician's Desk Reference "fit into the stimulant profile." Among others, these stimulant symptoms include headaches, nervousness, insomnia, anxiety, agitation, tremors, weight loss, nausea, diarrhea, mouth dryness, anorexia and excessive sweating.⁸

In short, a drug that acts as a stimulant also can overstimulate the body systems. In his book, Dr. Breggin offers the example of a person who takes Prozac to relieve depression (the beneficial effect) and suffers from agitation and insomnia (the negative effects). These adverse effects "are inherent in the stimulant effect that produces feelings of energy and well-being," Dr. Breggin writes. "In this sense, the difference between 'therapeutic effects' and 'toxic effects' are merely steps along a continuum from mild to extreme toxicity."⁹

With that in mind, what follows is a discussion of some of the side effects that have been associated with Prozac:

Akathisia. As noted, people may suffer from a variety of side effects when the central nervous system is overstimulated. Studies show that two effects of overstimulation--akathisia and agitation--are experienced by some people who take fluoxetine (the chemical name for Prozac).

Simply put, akathisia is a need to move about. The person feels anxious or irritable and is compelled to stand up, pace, shuffle his or her feet and the like. The inner sense of anxiety, says Dr. Breggin, is "like chalk going down a chalkboard, only it's your spine."¹⁰ Prozac also can cause extreme agitation, and this condition often is associated with akathisia.

Eli Lilly states in Prozac's information sheet that the drug can cause akathisia. However, Eli Lilly has said that less than 1 percent of Prozac users experience this side effect, while a 1989 report in the Journal of Clinical Psychiatry estimates that the actual share of Prozac users who suffer from akathisia is between 10 percent and 25 percent.¹¹ Other reports on the link between Prozac and akathisia have appeared in psychiatric journals.^{12, 13, 14}

Akathisia is related to a breakdown in the ability to control impulses. Thus, it has been associated with violent and suicidal acts in a number of studies and reports. A two-year study published in Psychopharmacology Bulletin in 1990 found a higher akathisia rating among people involved in violent acts than those who observed the incidents.¹⁵ Another double-blind clinical study established a link between akathisia and suicidal or homicidal thoughts, according to a report in the Journal of Clinical Psychopharmacology.¹⁶

Akathisia was associated with acts of extreme violence in an article in the American Journal of Forensic Psychiatry, which described three patients who attacked other people or committed murder.¹⁷ Other researchers have noted that patients who take Prozac and develop akathisia may, in turn, become preoccupied with thoughts of suicide.^{18, 19} A 1991 article in the Journal of Clinical Psychiatry, for example, reports on three patients who attempted suicide during fluoxetine treatment and were then reexposed to the drug. The second time around, all three developed severe akathisia and said the condition made them feel suicidal; they also attributed their previous suicide attempts to akathisia.²⁰

Psychosis. A person's nervousness may reach a psychotic level when the overstimulation of the nervous system is severe. People can become paranoid, extremely depressed, suicidal and dangerous to others around them. They may behave in bizarre ways, perhaps by spending all their money or directing traffic naked. The mental effects of fluoxetine treatment have been discussed in several psychiatric reports.^{21, 22}

More specifically, Prozac's ability to induce mania in patients has been documented in a number of medical journals.^{23, 24, 25, 26, 27, 28, 29, 30} This adverse effect supports Dr. Breggin's position, as stated earlier, that a drug's therapeutic effects and its toxic effects are simply a matter of degree in the same continuum. As he writes in his book, "Many patients who swear by Prozac are probably experiencing imperceptible or barely perceptible degrees of mania."³¹.

Suicide. Beyond the link between akathisia and acts of violence, some users of Prozac have said that the drug caused them to develop suicidal thoughts and obsessions. In some cases, the use of Prozac allegedly has prompted people to commit murder. This aspect of the drug has generated controversy and led to discussions in both medical publications and the general media about the connection between Prozac and acts of violence.^{32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46}

It should be noted that in several studies, the findings suggested that Prozac did not lead to suicidal preoccupation or found that the drug was not associated with an increased risk of suicidal acts. Other reports on clinical experiences with Prozac and its effects following an overdose support the safety of the drug.^{47, 48, 49, 50, 51, 52, 53, 54}

However, other research supports the contention that Prozac leads some users to become suicidal or violent. In his book, Dr. Breggin says that it is the drug's ability to cause a variety of psychological and neurological disorders that underlies such destructive behavior. Five of these disorders--agitation, panic, anxiety, mania and akathisia--can prompt suicidal or violent acts, says Breggin. Four other conditions caused by Prozac--depression, paranoia, obsessive-compulsive thoughts and behavior, and insomnia--may precipitate the irrational fears, suicidal thoughts and despair that lead to violent thoughts or actions.⁵⁵

What follows is a summary of some of the research on the link between Prozac and suicidal thoughts and behavior:

* A study published in the American Journal of Psychiatry in 1990 reported on the "surprising possibility that fluoxetine [Prozac] may induce suicidal ideation in some patients." This study, conducted by Dr. Martin Teicher and colleagues at Harvard Medical School, concerned six patients who were depressed but not suicidal before they started taking Prozac. Within weeks of taking the drug, said the researchers, the patients experienced "intense, violent suicidal preoccupation."⁵⁶

* In an analysis of 1,017 patients treated with antidepressant drugs by 27 psychiatrists, researchers found that 3.5 percent of those who took fluoxetine alone and 6.5 percent of those who took fluoxetine and tricyclics became suicidal only after their treatments began. The researchers concluded that the incidence of suicidal ideation was not significantly different between patients taking Prozac alone and those taking other drugs.⁵⁷ However, Dr. Teicher and his associates at Harvard Medical School have noted the results of this analysis support their suggestion that fluoxetine may precipitate suicidal ideation.⁵⁸

* Researchers at the State University of New York in Syracuse reported on "two patients in whom suicidal ideation and fluoxetine treatment were strongly associated" in the New England Journal of Medicine in 1991.⁵⁹

* A Prozac study involving children aged 10 to 17, conducted at the Yale University School of Medicine, found that "suicidal ideation of self-injurious behavior persisted for up to one month after the fluoxetine was discontinued," according to the researchers' report in the Journal of the American Academy of Child and Adolescent Psychiatry.⁶⁰

* Psychiatrist William Wirshing and associates reported in the Archives of General Psychiatry on five patients who developed akathisia when they took Prozac. They noted that the condition may have accounted for suicidal ideation in the patients.⁶¹

* In a 1990 letter to the American Journal of Psychiatry, a doctor described a patient who "developed depression and suicidal ideation approximately 30 days after beginning fluoxetine, [and] had had no previous suicidal ideation or attempts."⁶²

* In a report on antidepressants and suicidal tendencies, Dr. Teicher and his colleagues say that such medications may "redistribute" the risk of suicide, reducing the risk for some patients while possibly increasing it for others. They state, "Although antidepressants diminish suicidal behavior in many patients, about as many patients experience a worsening suicidal ideation on active medication as they do on placebo. Furthermore, at least as many patients attempted suicide on fluoxetine and tricyclic antidepressants as on placebo..."⁶³

The stories of individual patients also illuminates the effects of Prozac on some users. Perhaps the most notorious of these individuals is Joseph Wesbecker, who committed mass murder and then killed himself while he was taking Prozac. Wesbecker's rampage received national media attention after he went to his former place of employment in 1989 and shot 20 people, eight of them fatally, before killing himself.⁶⁴

Other Prozac users claim the drug made them hostile and suicidal. Janet Sims, for example, received Prozac for her "low mood" when she and her husband attended marriage counseling. She attacked her husband and became obsessed with suicide. Sims eventually underwent electric shock treatments.⁶⁵ Sharyn DiGeronimo became hostile, self-destructive and obsessed with suicide when she took Prozac because she was feeling down.⁶⁶

REFERENCES

1. Arizona inmate files $200 million suit, claims drug caused aggressive behavior, 18(37) Product Safety & Liability Reporter Liability Reporter, September 14, 1990, p. 1025-26.

2. Citizens Commission on Human Rights (CCHR), International Office, Los Angeles. Letter to The Honorable John D. Dingell, Chairman, Energy and Commerce Committee, House of Representatives, July 24, 1990.

3. Lewis J, Prozac: Dark side of a wonder drug, Trial, August 1990, p. 62-4.

4. CCHR, op cit.

5. Ibid.

6. Breggin PR and Breggin GR, Talking back to Prozac: What doctors aren't telling you about today's most controversial drug controversial drug. New York, St. Martin's Press, 1994, p. 121

7. Breggin, Talking Back to Prozac, p. 75.

8. Ibid, p. 78.

9. Ibid, p. 105.

10. Breggin PR, in interview with Gary Null. November 1994.

11. Lipinski JF, Mallya G, Zimmerman P, Pope HG, Fluoxetine-induced akathisia: clinical and theoretical implications, 59(9) Journal of Clinical Psychiatry, September 1989, p. 339-42.

12. Wirshing WC, Van Putten T, Rosenberg J, Fluoxetine, akathisia and suicidality: Is there a causal connection?, 49(7) Archives of General Psychiatry, July 1992, p. 580-81.

13. Sabaawi M, Holmes, TF, Fragala MR, Drug-induced akathisia: Subjective experience and objective findings, 159(4) Military Medicine, April 1994, p. 286-91.

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15. Crowner ML, Douyon R, Convit A, Gaztanaga P, Volavka J, Bakall R, Akathisia and violence, 26(1) Psychopharmacology Bulletin, 1990, p. 115-17.

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17. Schufte JL, Homicide and suicide associated with akathisia and haloperidol, American Journal of Forensic Psychiatry Psychiatry, Vol. VI, No. 2, 1985, p. 3.

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31. Breggin, Talking Back to Prozac, p. 103.

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51. Miller RA, Discussion of fluoxetine and suicidal tendencies, 147(11), American Journal of Psychiatry, November 1990, p. 1571.

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55. Breggin, Talking Back to Prozac, p. 176-77.

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61. Wirshing, op cit.

62. Dasgupta K, Additional cases of suicidal ideation associated with fluoxetine, 147(11) American Journal of Psychiatry Psychiatry, November 1990, p. 1570.

63. Teicher MH, Glod CA, Cole JO, Antidepressant drugs and the emergence of suicidal tendencies, 8(3) Drug Safety Safety, March 1993, p. 186-212.

64. Geoffrey C, A prozac backlash, Newsweek, April 1, 1991, p. 64.

65. Angier N, Eli Lilly facing million-dollar suits on its antidepressant drug Prozac, The New York Times, 117: August 16, 1990, p. B13.

66. Talan J, Worries over an antidepressant, Newsday, July 3, 1990, Part III, p. 1.

Originally published on www.garynull.com/documents/prozac1.htm

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