title: Serotonin reuptake inhibitors and hyperprolactinaemia: a case/non-case study in the French pharmacovigilance database.
abstract: BACKGROUND
  Hyperprolactinaemia is a common endocrinological disorder that can be caused by a variety of physiological and pathological conditions, although in a large proportion of cases hyperprolactinaemia is drug-induced. Serotonin reuptake inhibitors (SRIs) are reportedly associated with hyperprolactinaemia; however, the number of published cases in the literature is limited.
  
  
  OBJECTIVE
  The aim of the study was to investigate the association between exposure to SRIs and the risk of reporting of hyperprolactinaemia in a spontaneous reporting database.
  
  
  METHODS
  All cases of adverse drug reactions (ADRs) involving hyperprolactinaemia spontaneously reported to the French Pharmacovigilance Database from 1985 to December 2009 were reviewed. Cases of hyperprolactinaemia in SRI users were described. In a case/non-case analysis, the association between reported cases of hyperprolactinaemia and the use of SRIs was assessed by calculating reporting odds ratios (ROR) with their 95% confidence intervals (CIs).
  
  
  RESULTS
  A total of 11 863 reports with SRIs were collected, of which 187 reported hyperprolactinaemia ADRs. Subjects were 39.7 ± 13.5 years of age on average and mainly female (71%). We observed an increased risk of reporting of hyperprolactinaemia with the use of SRIs as antidepressants (overall ROR 3.3; 95% CI 2.8, 3.8), particularly with fluvoxamine (ROR 4.5; 95% CI 2.8, 7.2), citalopram (ROR 3.9; 95% CI 2.6, 5.8), fluoxetine (ROR 3.6; 95% CI 2.8, 4.7) and paroxetine (ROR 3.1; 95% CI 2.3, 4.2). Duloxetine, milnacipran and sertraline were not associated with an increased risk of reporting of hyperprolactinaemia.
  
  
  CONCLUSIONS
  Treatment with SRIs is associated with an increased risk of reported hyperprolactinaemia. When investigating the aetiology of diagnosed hyperprolactinaemia, physicians should systematically enquire about treatment with SRIs. The risk of hyperprolactinaemia should be mentioned in the labelling of all SRI compounds.
authors.affiliation: Regional Center for Pharmacovigilance and Pharmacoepidemiology, Reims University Hospitals, France. ttrenque@chu-reims.fr
authors.forename: Thierry
authors.initials: T
authors.lastname: Trenque
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Herlem
authors.forename: Pascal
authors.initials: P
authors.lastname: Auriche
authors.forename: Moustapha
authors.initials: M
authors.lastname: Dramé
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000009:adverse effects*; D016022:Case-Control Studies; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D006966:Hyperprolactinemia / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D012307:Risk Factors; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects*
chemical_list: D000928:Antidepressive Agents; D017367:Selective Serotonin Reuptake Inhibitors
references.citation: Neuroendocrinology. 1982 Feb;34(2):117-25
references.pmid: 6280090
references.citation: Aust N Z J Psychiatry. 1995 Dec;29(4):697
references.pmid: 8825840
references.citation: Encephale. 2002 Sep-Oct;28(5 Pt 1):411-7
references.pmid: 12386542
references.citation: Hum Psychopharmacol. 2010 Jun-Jul;25(4):281-97
references.pmid: 20521318
references.citation: Arch Gen Psychiatry. 1979 Oct;36(11):1183-6
references.pmid: 573606
references.citation: Prog Neuropsychopharmacol Biol Psychiatry. 2010 Apr 16;34(3):557-8
references.pmid: 20138200
references.citation: Mayo Clin Proc. 2005 Aug;80(8):1050-7
references.pmid: 16092584
references.citation: J Clin Psychopharmacol. 2003 Feb;23(1):109-10
references.pmid: 12544389
references.citation: Neuropharmacology. 2010 Jul-Aug;59(1-2):77-85
references.pmid: 20381503
references.citation: Neuropsychopharmacology. 2001 Sep;25(3):395-401
references.pmid: 11522467
references.citation: Psychiatry Investig. 2009 Sep;6(3):230-2
references.pmid: 20046401
references.citation: Drug Saf. 1999 Feb;20(2):109-17
references.pmid: 10082069
references.citation: J Clin Psychopharmacol. 1992 Aug;12(4):296-7
references.pmid: 1527236
references.citation: Ann Hum Genet. 1955 Jun;19(4):251-3
references.pmid: 14388528
references.citation: J Clin Psychopharmacol. 1996 Aug;16(4):333-4
references.pmid: 8835712
references.citation: Int J Psychiatry Med. 2007;37(3):275-8
references.pmid: 18314855
references.citation: Can J Psychiatry. 2002 Nov;47(9):890-1
references.pmid: 12500767
references.citation: Can J Psychiatry. 2001 Feb;46(1):88-9
references.pmid: 11221498
references.citation: Mayo Clin Proc. 2001 Feb;76(2):215-6
references.pmid: 11213313
references.citation: Am J Psychiatry. 2007 Jul;164(7):1121-2
references.pmid: 17606668
references.citation: Drug Saf. 2007;30(10):891-8
references.pmid: 17867726
references.citation: Am J Psychiatry. 1993 Aug;150(8):1269-70
references.pmid: 8093119
references.citation: Pharmacoepidemiol Drug Saf. 2003 Jun;12(4):271-81
references.pmid: 12812006
references.citation: Therapie. 2003 Mar-Apr;58(2):159-63
references.pmid: 12942857
references.citation: Med Clin (Barc). 2002 May 25;118(19):758-9
references.pmid: 12049712
references.citation: Pharmacopsychiatry. 2000 May;33(3):118
references.pmid: 10855465
references.citation: J Affect Disord. 1997 Nov;46(2):151-6
references.pmid: 9479619
references.citation: Neuropsychopharmacology. 2004 May;29(5):833-46
references.pmid: 14997175
references.citation: Am J Psychiatry. 1994 Sep;151(9):1395-6
references.pmid: 8067502
references.citation: J Am Acad Child Adolesc Psychiatry. 1992 Jul;31(4):755-6
references.pmid: 1644743
references.citation: Gen Hosp Psychiatry. 2006 May-Jun;28(3):230-3
references.pmid: 16675366
references.citation: Actas Esp Psiquiatr. 2001 Nov-Dec;29(6):414
references.pmid: 11730581
references.citation: Therapie. 1997 Jan-Feb;52(1):76-7
references.pmid: 9183928
references.citation: Drug Saf. 2010 Jul 1;33(7):569-78
references.pmid: 20553058
references.citation: Gen Hosp Psychiatry. 2010 May-Jun;32(3):341.e11-3
references.pmid: 20430243
references.citation: Prog Neuropsychopharmacol Biol Psychiatry. 2002 Dec;26(7-8):1235-43
references.pmid: 12502009
references.citation: Br J Clin Pharmacol. 1997 Nov;44(5):513-8
references.pmid: 9384470
references.citation: Endocrinol Metab Clin North Am. 2008 Mar;37(1):67-99, viii
references.pmid: 18226731
references.citation: Pharmacopsychiatry. 1997 Jul;30(4):133-4
references.pmid: 9271780
references.citation: Lancet. 1985 Nov 9;2(8463):1056-8
references.pmid: 2865527
references.citation: Endocrinol Metab Clin North Am. 1992 Mar;21(1):105-24
references.pmid: 1349524