4.5 Article

Suicidal Ideation and Suicidal Behavior as Rare Adverse Events of Antidepressant Medication: Current Report from the AMSP Multicenter Drug Safety Surveillance Project

Journal

INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY
Volume 21, Issue 9, Pages 814-821

Publisher

OXFORD UNIV PRESS
DOI: 10.1093/ijnp/pyy048

Keywords

antidepressants; SSRI; adverse drug reaction; suicide; drug safety

Funding

  1. Astra Zeneca Osterreich GmbH
  2. Boehringer Ingelheim Austria
  3. Bristol Myers Squibb GmbH
  4. CSC Pharmaceuticals GmbH
  5. Eli Lilly GmbH
  6. Germania Pharma GmbH
  7. GlaxoSmithKline Pharma GmbH
  8. Janssen-Cilag Pharma GmbH
  9. Lundbeck GmbH
  10. Novartis Pharma GmbH
  11. Pfizer Med Inform
  12. Wyeth Lederle Pharma GmbH
  13. Abbott GmbH Co. KG
  14. AstraZeneca GmbH
  15. Aventis Pharma Deutschland GmbH GE-O/R/N
  16. Bayer Vital GmbH Co. KG
  17. Boehringer Mannheim GmbH
  18. Bristol-Myers-Squibb
  19. Ciba Geigy GmbH
  20. Desitin Arzneimittel GmbH
  21. Duphar Pharma GmbH Co. KG
  22. Eisai GmbH
  23. esparma GmbH Arzneimittel
  24. GlaxoSmithKline Pharma GmbH Co. KG
  25. Hoffmann-La Roche AG Medical Affairs
  26. Janssen-Cilag GmbH
  27. Janssen Research Foundation
  28. Knoll Deutschland GmbH
  29. Lilly Deutschland GmbH Niederlassung Bad Homburg
  30. Lundbeck GmbH Co. KG
  31. Nordmark Arzneimittel GmbH
  32. Organon GmbH
  33. Otsuka-Pharma Frankfurt
  34. Pfizer GmbH
  35. Pharmacia Upjohn GmbH
  36. Promonta Lundbeck Arzneimittel
  37. Rhone-Poulenc Rohrer
  38. Sanofi-Synthelabo GmbH
  39. Sanofi-Aventis Deutschland
  40. Schering AG
  41. SmithKline Beecham Pharma GmbH
  42. Solvay Arzneimittel GmbH
  43. Synthelabo Arzneimittel GmbH
  44. Dr. Wilmar Schwabe GmbH Co.
  45. Thiemann Arzneimittel GmbH
  46. Troponwerke GmbH Co. KG
  47. Upjohn GmbH
  48. Wander Pharma GmbH
  49. Wyeth-Pharma GmbH
  50. AHP (Schweiz) AG
  51. AstraZeneca AG
  52. Bristol-Myers Squibb AG
  53. Desitin Pharma GmbH
  54. Eli Lilly (Suisse) S.A.
  55. Essex Chemie AG
  56. GlaxoSmithKline AG
  57. Janssen-Cilag AG
  58. Lundbeck (Suisse) AG
  59. Organon AG
  60. Pfizer AG
  61. Pharmacia
  62. Sanofi-Aventis (Suisse) S.A.
  63. Sanofi-Synthelabo SA
  64. Servier SA
  65. SmithKlineBeecham AG
  66. Solvay Pharma AG
  67. Wyeth AHP (Suisse) AG
  68. Wyeth Pharmaceuticals AG
  69. Angelini
  70. AOP Orphan Pharmaceuticals AG
  71. AstraZeneca
  72. Eli Lilly
  73. Janssen
  74. KRKA-Pharma
  75. Lundbeck
  76. Neuraxpharm
  77. Pfizer
  78. Pierre Fabre
  79. Schwabe
  80. Servier
  81. Lilly
  82. BMS
  83. Astra-Zeneca
  84. Bayer

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Background: Suicidal ideations, suicide attempts, and fatal suicides are rare adverse drug reactions to antidepressant drugs, but they essentially are clinically relevant. Drawing on a larger dataset of the European drug surveillance program, the present naturalistic study updates a previous contribution (Stikner et al., 2010). Methods: First an analysis of the comprehensive data collected in 81 psychiatric hospitals from 1993 to 2014 by the European drug surveillance program Arzneimittelsicherheit in der Psychiatrie was made. All documented single cases of suicidal ideations or behavior judged as adverse drug reactions to antidepressant drugs were carefully assessed as to their clinical features and drug prescriptions. Results: Among 219,635 adult hospitalized patients taking antidepressant drugs under surveillance, 83 cases of suicidal adverse drug reactions occurred (0.04%): 44 cases of suicidal ideation, 34 attempted suicides, and 5 committed suicides were documented. Restlessness was present in 42 patients, ego-dystonic intrusive suicidal thoughts or urges in 39 patients, impulsiveness in 22 patients, and psychosis in 7 patients. Almost all adverse drug reactions occurred shortly after beginning antidepressant drug medication or increasing the dosage. Selective serotonin reuptake inhibitors caused a higher incidence of suicidal ideation and suicidal behavior as adverse drug reactions than noradrenergic and specific serotonergic antidepressants or tricyclic antidepressants, as did monotherapy consisting of one antidepressant drug, compared to combination treatments. Conclusions: The study supports the view that antidepressant drug-triggered suicidal ideation and suicidal behavior (primarily with selective serotonin reuptake inhibitors) are rare. Special clinical features (restlessness, ego-dystonic thoughts or urges, impulsiveness) may be considered as possible warning signs. A combination therapy might be preferable to antidepressant drug monotherapy when beginning treatment.

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