EFFECT OF COUNSELING ON MATERNAL REPORTING OF ADVERSE-EFFECTS IN NURSING INFANTS EXPOSED TO ANTIBIOTICS THROUGH BREAST-MILK

In a recent trial, we found that nursing women reported diarrhea in th eir nursing infants after maternal use of antibiotics. However, becaus e they were told that this could occur during a medication counseling session, the observed effect could have been due to a reporting bias. The objectives of this study were to determine if counseling nursing w omen about side effects of antibiotic they used could (a) influence th e adverse event reporting rate or (b) influence maternal nursing and m edication compliance behavior. In a randomized, controlled trial, nurs ing women calling a teratogen information service for advice about sel ected antibiotics received one of two possible counseling formats (A a nd B). Both groups were informed that the antibiotics were safe to use . Mothers in group B were also informed about a theoretical risk of di arrhea in the infant. Mothers later reported clinical events they note d in the infants and judged whether they were due to the antibiotic. E ighty-seven percent (54/62) of group A subjects compared to 68% (52/76 ) of group B subjects reported clinical events in their infants during their antibiotic therapy (P = 0.017). The incidence of reported diarr hea was 26% in group A compared to 17% in group B (P = 0.3); 34% of su bjects in both groups attributed clinical events to antibiotic therapy (P = 1.0). Diarrhea was attributed to antibiotic therapy in 13% of gr oup A and 12% of group B subjects (P = 1.0). No differences were obser ved between groups in breastfeeding pattern and antibiotic compliance. Breastfeeding women counseled about adverse effects were not more lik ely to report side effects in their infants or to change nursing behav ior and medication compliance.