A Study of Adverse Drug Reactions to Iron among Pregnant Women of a Teaching Hospital
Keywords:
ADR, Iron, Supplement, SafetyAbstract
Objective: To study the incidence of Adverse Drug Reactions (ADRs) to common iron preparations among the women attending the antenatal care clinic of a teaching hospital and associations with clinical, pharmacological and lifestyle factors.
Methods: This cross sectional study was conducted from May to July 2021 after obtaining approval from the institutional ethical committee and enrolled pregnant women with pre-assessed laboratory parameters. Case report form entailed details about demographic, lifestyle-related and clinical data and details of iron supplement-related information. ADRs were documented using a checklist from KD. Tripathi, WHO-UMC assessment for causality, Hartwig assessment for severity and modified Schumock and Thorton assessment for preventability of ADRs.
Results: Among 156 participants who fulfilled the inclusion criteria, 46 were reported to have at least 1 ADR which were more for oral iron therapy compared to parenteral preparations (94.2% vs 5.8% P= 0.077), the most common adverse reaction among oral iron users was heartburn. 84.8% of these ADRs were probable in causality, mild in severity and probably preventable. ADRs were documented more for women who consumed iron and calcium supplements together (40.8% vs 59.2% P=0.007) and among the upper and upper middle classes compared to middle, lower middle and lower classes (91.7% vs 8.3% P=0.036).
Conclusion: ADRs to common drugs like iron are often unreported. They were found to be more incident among oral iron users but it is the preferred mode of therapy due to its ease of use and price. Better therapeutic advice and vigilance can be minimize ADR occurrence.
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