Psy-World

Treatment with selective serotonin reuptake inhibitors is associated with an increased risk of hyperprolactinaemia.

Hyperprolactinaemia is caused by an increase in prolactin secretion from the pituitary gland. With a prevalence of 1-1.5% this endocrine abnormality may be caused by a number of pathological and pharmacological conditions. In the majority of cases, hyperprolactinaemia is drug-induced. Among the drugs that can cause hyperprolactinaemia are selective serotonin reuptake inhibitors (SSRIs), although few clinical reports concerning this association are currently available. The aim of a case/non-case study was to investigate the association between exposure to SSRIs and the reporting of hyperprolactinaemia using data from the spontaneous-reporting French Pharmacovigilance Database (FPVD) from 1985 to December 2009. A total of 369 778 spontaneous reports of adverse drug reactions (ADRs) had been recorded in the FPVD, among which 11 863 mentioned SSRIs as the suspected medication. Overall, a total of 1910 cases of reported hyperprolactinaemia were identified, among which 187 concerned SSRIs [clinical signs: amenorrhoea (n = 21), galactorrhoea (n = 102), gynaecomastia (n = 54) or mastodynia (n = 21)]. The average age was 39.7 ± 13.5 years and 71.1% were female. An increased risk of reporting of hyperprolactinaemia was found with the use of SSRIs as antidepressants (overall reporting odds ratios (ROR) 3.3, particularly with fluvoxamine (ROR 4.5), citalopram (ROR 3.9), fluoxetine (ROR 3.6) and paroxetine (ROR 3.1). In contrast, treatment with duloxetine, milnacipran and sertraline was not associated with an increased risk of reporting of hyperprolactinaemia. Faced with patients diagnosed with hyperprolactinaemia, physicians should systematically enquire about treatment with SSRIs. The risk of occurrence of hyperprolactinaemia (with or without clinical signs) should be explicitly mentioned in the labelling of all SSRIs. Trenque T, Herlem E, Auriche P, Dramé M (2011). Serotonin reuptake inhibitors and hyperprolactinaemia: a case/non-case study in the French pharmacovigilance database. Drug Saf 34:1161-1166. Updated December 2011