REACCIONES ADVERSAS POR MEDICAMENTOS EN EMBARAZADAS, REPORTADAS AL SISTEMA DE FARMACOVIGILANCIA DE CUBA EN LOS A OS 2003 - 2007

Our observational, descriptive, transversal and retrospective study was made to distinguish the suspicion of drugs adverse effects (DAE) during pregnancy that were notified to the National Coordinator Pharmacovigilance Unit. The study comprised since 2003 to 2007. It was based in the spontaneous notification method of suspicion of DAE. The complete reports of the choiced period of time were selected. The investigators identified the drugs more proclive to produce DAE. They were classified according to their pregnancy risk. The DAE were classified pursuant to severity, causality and frequency. It was also determined evitable DAE and avoidance′s causes.Drugs that provoke DAE more frequently were Prenatal (a combination of fixed doses of ferrous fumarate, folic acid, ascorbic acid and retinol) (27, 7%) (No pregnancy risk categorized), ferrous fumarate (6, 9%) (A category), metronidazol (5, 9%) (B category) and hyperbaric lidocaine (4.8%). Mild (65.9%), probable (63.8%) and frequently (66%) were the predominant DAE. The avoidable DAE constituted an 8, 3% and the main avoidance causes were unsuitable doses and indications. Drugs without pregnancy risk category were the drugs that provoked more DAE.The severity and the causality were similar to those described in the general population of Cuba in the study′s period of time, except the frequency of the occurrence because low frequency DAE reports diminished in the progress of the years (from 39.2% in 2003 to 29.6% in 2007) although in the Cuban general population low frequency DAE reports increased (from 11.3% in 2003 to 35.9% in 2007). A small proportion of DAE were avoidable but they caused serious health damages to health, provoking two deaths.