Galactorrhea and Antipsychotic Use: Data from the AMSP

Within the drug safety program in psychiatry AMSP (Arzneimittelsicherheit in der Psychiatrie) severe adverse drug reactions (ADR) are assessed. Currently 35 psychiatric hospitals and departments are participating in detecting severe ADR. This presentation focuses on the prolactin-dependent ADR galactorrhea due to antipsychotic medications. Related to the number of patients surveyed (122.562 from 1993–2000) these are rare events (0.03%). Women are the population mainly at risk concerning galactorrhea induced by antipsychotics. In the group of antipsychotics, relative frequencies of galactorrhea observed here correspond to the degree of D2-binding. Galactorrhea assessed as ‘severe’ was seriously incommodating patients or accompanied by distressing symptoms like pain, tension, enlargement of breasts, weight gain or soaked clothing. Galactorrhea appeared mostly in week one two after administration of a new drug and dosages were within normal range compared to patients without this ADR. Management of this ADR implied discontinuation or reduction of the drugs. The AMSP data contribute to the knowledge on endocrine ADR by the large number of patients examined and help clinicians select the appropriate drug if their patients have been sensitive for these ADR in the past.