THE DANGERS OF PROZAC: Part 1

June 3, 2007

THE DANGERS OF PROZAC: Part 1By Gary Null, Ph.D. and Martin Feldman, M.D.

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Nearly a decade has passed since Prozac, the antidepressant drug, was introduced to themarket 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 earlyclaims that Prozac would alleviate depression without causing harmful side effects havenot been realized.

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

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

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

A 1990 article in Trial, published by the Association of Trial Lawyers ofAmerica, also points to the "dark side" of Prozac, noting that it not onlyproduces troubling side effects but also can be harmful and even deadly when combined withcertain other drugs. "Prozac has greatly benefited many severely depressed patients.Others, however, have suffered serious side effects," states the report. "EliLilly & Co.'s failure to adequately warn physicians of side effects and of the dangerof drug interactions has doubtless resulted in injuries that could otherwise have beenavoided. Now that the dangers are better known, doctors should inform patients of theserisks."3

THE SIDE EFFECTS OF PROZAC

The CCHR letter notes that the Food and Drug Administration (FDA) received almost twiceas many adverse reaction reports on Prozac in two years than it did on Elavil, anotherantidepressant, in 20 years. Even Valium, a widely used prescription drug, accumulatedfewer 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 thatconnects receptor sites and fires nerve cells. The CCHR letter states that the drug'schemical structure, which is unlike that of other medications, makes it "an utterwild card" in predicting what effects it may have.5And yet, doctors not only prescribe Prozac for depression, its approved use, but also forsmoking cessation, weight loss and other problems.

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

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

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

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

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

Simply put, akathisia is a need to move about. The person feels anxious or irritableand is compelled to stand up, pace, shuffle his or her feet and the like. The inner senseof anxiety, says Dr. Breggin, is "like chalk going down a chalkboard, only it's yourspine."10 Prozac also can cause extremeagitation, 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 sideeffect, while a 1989 report in the Journal of Clinical Psychiatry estimates thatthe actual share of Prozac users who suffer from akathisia is between 10 percent and 25percent.11 Other reports on the link betweenProzac and akathisia have appeared in psychiatric journals.12,13, 14

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

Akathisia was associated with acts of extreme violence in an article in the AmericanJournal of Forensic Psychiatry, which described three patients who attacked otherpeople or committed murder.17 Other researchers havenoted that patients who take Prozac and develop akathisia may, in turn, become preoccupiedwith thoughts of suicide.18, 19 A 1991 article in the Journalof Clinical Psychiatry, for example, reports on three patients who attemptedsuicide during fluoxetine treatment and were then reexposed to the drug. The second timearound, all three developed severe akathisia and said the condition made them feelsuicidal; they also attributed their previous suicide attempts to akathisia.20

Psychosis. A person's nervousness may reach a psychotic level when theoverstimulation of the nervous system is severe. People can become paranoid, extremelydepressed, 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 offluoxetine treatment have been discussed in several psychiatric reports.21,22

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

Suicide. Beyond the link between akathisia and acts of violence, some users ofProzac have said that the drug caused them to develop suicidal thoughts and obsessions. Insome cases, the use of Prozac allegedly has prompted people to commit murder. This aspectof the drug has generated controversy and led to discussions in both medical publicationsand 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 notlead to suicidal preoccupation or found that the drug was not associated with an increasedrisk of suicidal acts. Other reports on clinical experiences with Prozac and its effectsfollowing 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 becomesuicidal or violent. In his book, Dr. Breggin says that it is the drug's ability to causea variety of psychological and neurological disorders that underlies such destructivebehavior. Five of these disorders--agitation, panic, anxiety, mania and akathisia--canprompt suicidal or violent acts, says Breggin. Four other conditions caused byProzac--depression, paranoia, obsessive-compulsive thoughts and behavior, andinsomnia--may precipitate the irrational fears, suicidal thoughts and despair that lead toviolent thoughts or actions.55

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

* A study published in the American Journal of Psychiatry in 1990reported on the "surprising possibility that fluoxetine [Prozac] may induce suicidalideation in some patients." This study, conducted by Dr. Martin Teicher andcolleagues at Harvard Medical School, concerned six patients who were depressed but notsuicidal before they started taking Prozac. Within weeks of taking the drug, said theresearchers, the patients experienced "intense, violent suicidal preoccupation."56

* In an analysis of 1,017 patients treated with antidepressant drugs by 27psychiatrists, researchers found that 3.5 percent of those who took fluoxetine alone and6.5 percent of those who took fluoxetine and tricyclics became suicidal only after theirtreatments began. The researchers concluded that the incidence of suicidal ideation wasnot significantly different between patients taking Prozac alone and those taking otherdrugs.57 However, Dr. Teicher and his associates atHarvard Medical School have noted the results of this analysis support their suggestionthat fluoxetine may precipitate suicidal ideation.58

* Researchers at the State University of New York in Syracuse reported on "twopatients 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 UniversitySchool of Medicine, found that "suicidal ideation of self-injurious behaviorpersisted for up to one month after the fluoxetine was discontinued," according tothe researchers' report in the Journal of the American Academy of Child andAdolescent Psychiatry.60

* Psychiatrist William Wirshing and associates reported in the Archives of GeneralPsychiatry on five patients who developed akathisia when they took Prozac. They notedthat 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 apatient who "developed depression and suicidal ideation approximately 30 days afterbeginning fluoxetine, [and] had had no previous suicidal ideation or attempts."62

* In a report on antidepressants and suicidal tendencies, Dr. Teicher and hiscolleagues 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 manypatients experience a worsening suicidal ideation on active medication as they do onplacebo. Furthermore, at least as many patients attempted suicide on fluoxetine andtricyclic antidepressants as on placebo..."63

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

Other Prozac users claim the drug made them hostile and suicidal. Janet Sims, forexample, received Prozac for her "low mood" when she and her husband attendedmarriage counseling. She attacked her husband and became obsessed with suicide. Simseventually underwent electric shock treatments.65

Dangers of Prozac Part 2

REFERENCES

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

2. Citizens Commission on Human Rights (CCHR), International Office, LosAngeles. Letter to The Honorable John D. Dingell, Chairman, Energy and CommerceCommittee, 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 doctorsaren't telling you about today's most controversial drug. New York, St. Martin'sPress, 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-inducedakathisia: clinical and theoretical implications, 59(9) Journal of ClinicalPsychiatry, September 1989, p. 339-42.

12. Wirshing WC, Van Putten T, Rosenberg J, Fluoxetine, akathisia andsuicidality: 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: Subjectiveexperience and objective findings, 159(4) Military Medicine, April 1994, p.286-91.

14. Kalda R, Media- or fluoxetine-induced akathisia, 150(3) AmericanJournal of Psychiatry, March 1993, p. 531-32.

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

16. Shear KM, Frances A, Weiden P, Suicide associated with akathisia anddepot fluphenazine treatment, Journal of Clinical Psychopharmacology, August1983, p. 235-36.

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

18. Power AC, Cowen, PJ, Fluoxetine and suicidal behavior: Some clinicaland theoretical aspects of a controversy, 161(12) British Journal of Psychiatry,December 1992, p. 735-41.

19. Hamilton MS, Opler LA, Akathisia, suicidality, and fluoxetine, 53(11) Journalof Clinical Psychiatry, November 1992, p. 401-6.

20. Rothschild, AJ, Locke CA, Reexposure to fluoxetine after serioussuicide attempts by three patients: The role of akathisia, 52(12) Journal ofClinical Psychiatry, December 1991, p. 491-3.

21. Hersh CB, Sokol MS, Pfeffer CR, Transient psychosis with fluoxetine,30(9) Journal of the Academy of Child and Adolescent Psychiatry, September1991, p. 851.

22. Mandalos GE, Szarek BL, Dose-related paranoid reaction associated withfluoxetine, Journal of Nervous and Mental Disease, 1990, 178:57-8.

23. Nakra BR, Szwabo P, Grossberg GT, Mania induced by fluoxetine, 146(11)American Journal of Psychiatry, November 1989, p. 1515-16.

24. Sholomskas AJ, Mania in a panic disorder patient treated withfluoxetine, 147(8) American Journal of Psychiatry, August 1990, p. 1090-91.

25. Venkataraman S, Naylor MW, King CA, Mania associated with fluoxetinetreatment in adolescents, 31(2) Journal of the Academy of Child and AdolescentPsychiatry, March 1992, p. 276-81.

26. Piredda SG, Rubinstein SL, Hypomania induced by fluoxetine?, 32(1) BiologicalPsychiatry, July 1992, p. 107.

27. Hon D, Preskorn SH, Mania during fluoxetine treatment for recurrentdepression, 146(12) American Journal of Psychiatry, December 1989, p. 1638-39.

28. Lebegue B, Mania precipitated by fluoxetine, 144(12) American Journalof Psychiatry, December 1987, p. 1620.

29. Chouinard G, Steiner W, A case of mania induced by high-dosefluoxetine treatment, American Journal of Psychiatry, May 1986, p. 686.

30. Turner SM, Rolf JG, Beidel DC, Griffin S, A second case of maniaassociated with fluoxetine, 142(2) American Journal of Psychiatry, February1985, p. 274-75.

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

32. Angier N, Suicidal behavior tied again to drug, New York Times,February 7, 1991, p. B15.

33. Associated Press, Third lawsuit against Ely Lilly AntidepressantDrug, Chicago Tribune, August 8, 1990.

34. Belli A, Family Takes on Drug Firm: Prozac blamed on man's suicide, TheDallas Morning News, June 23, 1991.

35. Blodgett N, Eli Lilly drug targeted, ABA Journal, November1990, p. 24.

36. Cassada ME, Prozac noted by Massey's attorney, Danville Register & Bee, September 17, 1991.

37. Charles H, Woman who took Prozac, killed husband gets probation, Press-Telegram,April 20, 1991.

38. The Economist (London), Prozac and suicide: Open verdict,January 19, 1991, p. 76.

39. Dewan MJ, Prakash M, Prozac and suicide, Journal of Family Practice,1991, 33:312.

40. Drake RE, Ehrlich J, Suicide attempts associated with akathisia, AmericanJournal of Psychiatry, April 1985, p. 499-501.

41. Fetner H, Watts H, Geller B, Fluoxetine and preoccupation withsuicide, 148(9) American Journal of Psychiatry, September 1991, p. 258.

42. Hoover CE, Additional cases of suicidal ideation associated withfluoxetine, 147(11) American Journal of Psychiatry, November 1990, p. 1570-71.

43. Tollefson GD, Fluoxetine and suicidal ideation, 147(12) AmericanJournal of Psychiatry, December 1990, p. 1691-92.

44. Breggin P, A case of fluoxetine-induced stimulant side effects withsuicidal ideation associated with a possible withdrawal reaction ('crashing'), InternationalJournal of Risk and Safety in Medicine, 1992, 3:325-28.

45. Breggin P, News and Views on Psychiatry: Prozac, suicide and violence:An analysis with reports from the Prozac Survivors Support Group, Inc., The RightsTenet, Winter/Spring 1991. p. 4-6.

46. Brewerton TD, Fluoxetine-induced suicidality, serotonin, andseasonality, Biological Psychiatry, 1991, 30:190-96.

47. Ashleigh AE, Fesler AF, Fluoxetine and suicidal preoccupation, 149(12)American Journal of Psychiatry, December 1992, p. 1750.

48. Beal DM, Harris D, Bartos M, Korsak C, Safety and efficacy offluoxetine, 148(12) American Journal of Psychiatry, December 1991, p. 1751.

49. Warshaw MG, Keller MB, The relationship between fluoxetine use andsuicidal behavior in 654 subjects with anxiety disorders, 57(4) Journal of ClinicalPsychiatry, April 1996, p. 158-66.

50. Beasley CM Jr., Dornseif BE, Bosomworth JC, Sayler ME, Rampey AH Jr.,Heiligenstein JH, Thompson VL, Murphy DJ, Masica DN, Fluoxetine and suicide: Ameta-analysis of controlled trials of treatment for depression, BMJ, September 21,1991, 303:6804, p. 685-92.

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

52. Berkley RB, Discussion of fluoxetine and suicidal tendencies, 147(11),American Journal of Psychiatry, November 1990, p. 1572.

53. Henry JA, Toxicity of antidepressants: Comparisons with fluoxetine, IntClin Psychopharmacol, June 1992 (6 Suppl), p. 22-7.

54. Borys DJ, Setzer SC, Ling LJ, Reisdorf JJ, Day LC, Krenzelok EP, Acutefluoxetine overdose: A report of 234 cases, 10(2) Am J Emerg Med, March 1992,p. 115-20.

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

56. Teicher MH, Glod C and Cole JO, Emergence of Intense SuicidalPreoccupation during fluoxetine treatment, 147(2) American Journal of Psychiatry,February 1990, p. 207-10.

57. Fava M, Rosenbaum JF, Suicidality and fluoxetine: Is there arelationship?, 52(3) Journal of Clinical Psychiatry, March 1991, p. 108-11.

58. Teicher MH, Glod CA, Cole JO, Dr. Teicher and associates reply [toTollefson], 147(12) American Journal of Psychiatry, December 1990, p. 1692-93.

59. Masand P, Gupta S and Dewan M, Suicidal ideation related to fluoxetinetreatment, letter in 324(6) New England Journal of Medicine, 324: February 7,1991, p. 420.

60. King RA, Riddle MA, Chappell PB, Hardin MT, Anderson GM, Lombroso Pand Scahill L, Emergence of self-destructive phenomena in children and adolescentsduring fluoxetine treatment, 30(2) Journal of the American Academy of Child andAdolescent Psychiatry, March 1991, p. 179.

61. Wirshing, op cit.

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

63. Teicher MH, Glod CA, Cole JO, Antidepressant drugs and the emergenceof suicidal tendencies, 8(3) Drug 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 antidepressantdrug Prozac, The New York Times, 117: August 16, 1990, p. B13.