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SSRIs, Akathisia, and Suicidality Joseph Glenmullen, MD Clinical Instructor in Psychiatry, Harvard University Author of Prozac Backlash.

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Presentation on theme: "SSRIs, Akathisia, and Suicidality Joseph Glenmullen, MD Clinical Instructor in Psychiatry, Harvard University Author of Prozac Backlash."— Presentation transcript:

1 SSRIs, Akathisia, and Suicidality Joseph Glenmullen, MD Clinical Instructor in Psychiatry, Harvard University Author of Prozac Backlash

2 Press Briefing at the February 2, 2004 FDA Meeting on the Concern that SSRI Antidepressants Can Make Children and Adolescents Suicidal

3 Objective: To relate the data from studies of SSRIs to the realities faced by doctors and patients when SSRIs trigger suicidality

4 I have witnessed this side effect in patients who I treat with SSRIs

5 Akathisia and Suicidality— Side Effects of SSRIs

6 Diagnostic and Statistical Manual (DSM) n “Serotonin-specific reuptake inhibitor [SSRI] antidepressant medications may produce akathisia.” n A class effect of all SSRIs n American Psychiatric Association n 2000 Edition, p. 801

7 DSM (Continued) n “Akathisia may be associated with dysphoria [psychological distress], irritability, aggression, or suicide attempts.”

8 APA Textbook of Psychopharmacology n “Akathisia, however, is the most common neurological symptom caused by SSRIs.” p. 939 n Edited by Schatzberg and Nemeroff n Second Edition, 1998, p.939

9 Based on Numerous Reports n American Journal of Psychiatry n New England Journal of Medicine n Archives of General Psychiatry n Journal of Family Practice n Journal of the American Academy of Child and Adolescent Psychiatry n Human Psychopharmacology n Journal of Family Practice

10 The Two Faces of Akathisia n Well-known from antipsychotics, an earlier class of drugs n Outer, objective restlessness n Inner, subjective agitation

11 Outer, Visible Restlessness n Mild: Adjust posture, shift weight, cross and uncross legs n Moderate: Visibly jittery, tap feet, pace n Severe: Ceaseless pacing, cannot sit or lie still

12 Inner, Subjective Agitation n Abject terror n Anxiety n Tension n Irritability n Hostility n Paranoia n Rage reactions n Violence

13 Suicide Offers a “Welcome Relief” from Akathisia

14 Vulnerable Time Period n Early weeks or month after n Starting the drug n Increasing the dose

15 The Suicidality of Akathisia Is Distinctly Different from the Suicidality of Depression n Preoccupation with escape from the abject terror, anxiety, and irritability of physical and psychological state of akathisia versus preoccupation with the guilt, self-hatred,and hopelessness of depression

16 Treatment of Akathisia n Decrease dose n Stop drug n Add propranolol or Valium-type antianxiety agent n Switch to another class of antidepressant

17 Brain Chemistry of SSRI Akathisia n The serotonin-dopamine connection n Antidepressants “selective” for serotonin appear to pose a greater risk of akathisia than other antidepressants

18 Other Side Effects of SSRIs that Increase the Risk of Suicide n Mania n Insomnia n Anxiety n Paranoia n Psychotic reactions

19 Primary Care Doctors Now Write 70% of Prescriptions for Antidepressants and Know Little about this Side Effect

20 Re-Challenge Studies n “Try the drug a second time” in patients who had the side effect to see if they experience it again n The best way to study and describe what actually happens to patients

21 Re-Challenge Studies of SSRIs n Rothschild (Harvard) Journal of Clinical Psychiatry,1991 n Van Putten (UCLA) Archives of General Psychiatry, 1992 n Hamilton and Opler (Columbia) Journal of Clinical Psychiatry, 1992 n All the patients developed akathisia and suicidality again

22 Eli Lilly Agreed to Fund a Large Re-Challenge Study n Spring 1991 n Reached agreement with the FDA at the height of the crisis over this side effect in the early 1990s n Lilly developed the protocols for the study n Lilly never did the study

23 The September 1991 FDA Meeting on this Side Effect Is Widely Reported to Have Unanimously Exonerated SSRIs

24 But… n The FDA had to waive its own standards for conflicts-of-interest for 5 of the 9 committee members and 4 of the 6 consultants because of their ties to the pharmaceutical industry n On one of the votes taken by the committee, one-third of the committee members voted for a warning

25 Transcript of the 1991 FDA Meeting on this Side Effect n Dr. Nina Schooler: “We really do need to obtain more data…At one level” the data “is a fairly sorry state” because of its inability to adequately describe what happens to patients. Page 329 n “Somehow, for me, the responses to this end up being always with that caveat…” Page 303

26 Transcript of the 1991 FDA Meeting on this Side Effect n Dr. John Mann: “I want to endorse [i.e. second] the need for better data.” Page 298

27 Transcript of the 1991 FDA Meeting on this Side Effect n Dr. Daniel Casey (Chairman): n “I know you [committee members] want the caveat that ‘I don’t feel I have all the data.’” Page 269 n “There will be more research. At least I certainly hope so.” Page 297

28 January 2004 FDA Memorandum for this Meeting n 12 years later the data is still: n “a distinctly insensitive approach…to [assessing] suicidality” and describing what actually happens to patients. Page 7

29 January 2004 FDA Memorandum for this Meeting n The data is “generally inadequate.” Page 17

30 January 2004 FDA Memorandum for this Meeting n “There is one caveat to this effort” because the data is of “unknown sensitivity” and “may have missed certain events” related to suicidality. Page 15

31 January 2004 FDA Memorandum for this Meeting n 12 years later, the FDA still wants “more adequate assessment for emergent suicidality in future studies.” Page 17

32 For How Many Decades Are We Going to Get Together to Lament the Inadequacy of the Pharmaceutical Industry’s Efforts to Clarify this Phenomenon?

33 The Industry Response n Dismiss serious medical case reports and small-scale studies, which are all solo practitioners can afford to do, as “anecdotes”

34 The Industry Response n Blame patient’s psychiatric conditions

35 The Industry Response n Scare the media and other interested parties away from the subject by citing a fear that patients will be frightened away from treatment

36 Authoritarian Approach n Don’t warn patients, you might frighten them

37 The most dangerous scenario: When neither the doctor nor the patient knows about akathisia

38 What if you were considering an SSRI for your child? n If you would want to be informed about this side effect if you were considering an SSRI for your child, please use your power as journalists to inform the public.


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