Abstract

Background: Adverse drug reactions (ADRs) in women demand a special care due to altered physiology. Despite lingering safety questions, studies on vulnerable groups such as pregnancy, lactation, peri- and post-menopausal women are lacking. Hence, the assessment of ADRs is essential for early risk detection and its management. Aims and Objectives: To analyze the pattern, causality, severity, predictability and preventability of occurrence of ADRs in the Obstetrics and Gynecology (OBG) Department.
Materials and Methods: An observational study was conducted from June 2012 to 2016 to analyze the ADRs reported spontaneously from the Department of OBG to ADR Monitoring Center, Bangalore Medical College and Research Institute. Causality of each ADR was assessed by the WHO-ADR scale, severity by Hartwig and Siegel scale and preventability by modified Schumock and Thornton scale.
Results: A total of 100 ADRs were reported over 48 months; a maximum number of ADRs were observed in the age group of 21–40 years (81%) and majority of them during pregnancy (62%). The highest number of ADRs was associated with iron therapy (42%) followed by antimicrobials (31%). Gastrointestinal system (51%) was affected predominantly. Gastritis (25%) followed by allergic reactions (18%) was most commonly observed ADRs. The WHO-UMC criteria showed that 61% were “probable” and 57% were “mild” in nature. Preventability assessment showed that 56% were “probably preventable” ADRs. Furthermore, 72% of the ADRs were predictable in nature. 43% of the ADRs required additional medical treatment, while causative drug was withdrawn in 44% of cases. Conclusion: This study provides a database of ADRs in the OBG Department and most of the ADRs were predictable and probably preventable with no severe ADRs, which highlights the appropriate management of ADRs at our center