Adverse Drug Reactions in Cuban Pregnant Women from 2003 to 2013

Abstract

Introduction: There is no knowledge of the characteristics of adverse drug reactions in Cuban pregnant women or the signs of new adverse reactions during a decade of notification.
Objectives: To characterize adverse drug reactions in pregnant women reported to the Pharmacovigilance System from 2003 to 2013. To identify signs of new adverse reactions.
Method: This study had two stages. The first stage was descriptive and transversal, the second was analytical. The source of information was the national pharmacovigilance database. We calculated the relative proportional risk (RRP) to detect signals. Experts subjected the drug-adverse reaction pairs with RRP > 2 (p ? 0, 05) to qualitative evaluation.
Results: The reporting rate of adverse reactions was 1 536, 6 / 105 pregnant. The age group of 40 and older (2 357, 8 / 105) was the most affected. The predominant adverse drug reactions were vomiting (22, 8%), mild (52, 8%), probable (64, 9%) and frequent (65, 9%) produced more by antiviral drugs (21,1%) and oseltamivir (21,9%). Graduates in pharmacy (37, 2%) reported more from secondary health care (60,9%). Seven warnings and a signal were detected.
Conclusions: Adverse drug reactions in pregnant women detected in a decade showed different characteristics than those reported at the international and national levels. The signal of a new adverse reaction was generated by an antiviral that was under intensive surveillance.