Hyperprolactinaemia is a relatively common endocrine abnormality caused by an increased secretion of
prolactin from the pituitary gland. There are many causes of
hyperprolactinaemia;
drug therapy is a common cause in clinical practice. The present pharmacoepidemiological study conducted an analysis of the French Pharmacovigilance Database from January 1, 1985, to December 2000. We investigated the rates of
hyperprolactinaemia according to therapeutic
drug class, particularly where the Summaries of Product Characteristics (SPC) did not mention
hyperprolactinaemia, and estimated the risk of developing
hyperprolactinaemia during treatment. We calculated the odds ratio (OR) of reports associated with
hyperprolactinaemia for all drugs. Of the 182,836 spontaneous
adverse drug reactions reported to the French Pharmacovigilance network, 159 were
hyperprolactinaemia. The sex ratio was 5.9 (136 women and 29 men), and mean age was 40 (range 14-85) years. Of the total number of adverse reactions, 31% were associated with
neuroleptics, 28% with
neuroleptic-like drugs, 26% with
antidepressants, 5% with H2-receptor antagonists, and 10% with other drugs.
Neuroleptics are not the only class of drugs for which
hyperprolactinaemia is reported. Some drugs are clearly associated with an increased risk of
hyperprolactinaemia, particularly the following:
veralipride (OR = 108.7; IC 95%: 51.82-228),
indoramin (OR = 78.68; IC 95%: 33.93-182.48),
sertraline (OR = 15.74; IC 95%: 5.80-42.75), and
ranitidine (OR = 4.43; IC 95%: 1.82-10.81). All these drugs are reported in the literature as inducing
hyperprolactinaemia, although this adverse effect is not mentioned in the SPC. It is thus necessary to harmonise the SPC and encourage health professionals to notify all adverse reactions to their pharmacovigilance centres.