Adverse drug reactions in high-risk pregnant women: A prospective study

Because pregnant women are often excluded from clinical trials, there is still very limited information about the risk and safety of prescription drugs during pregnancy. We aimed to determine the prevalence of Adverse Drug Reactions (ADRs) in high-risk pregnant women after hospital admission. A pros...

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Published inSaudi pharmaceutical journal Vol. 25; no. 7; pp. 1073 - 1077
Main Authors de Oliveira-Filho, Alfredo Dias, Vieira, Antonio Emanuel Soares, da Silva, Roberta Cruz, Neves, Sabrina Joany Felizardo, Gama, Thiago Antonio Barros, Lima, Ryane Vieira, Oliveira, Wlisses Ramon, de Gonçalves Dias, Júlia Maria
Format Journal Article
LanguageEnglish
Published Saudi Arabia Elsevier B.V 01.11.2017
Elsevier
Subjects
Adverse drug reactions
Drug-drug interactions
Ferrous sulfate
High-risk pregnancy
Maternal age
Methyldopa
Prevalence
Prevalence
Maternal age
Ferrous sulfate
Methyldopa
Drug-drug interactions
Adverse drug reactions
High-risk pregnancy
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Summary:Because pregnant women are often excluded from clinical trials, there is still very limited information about the risk and safety of prescription drugs during pregnancy. We aimed to determine the prevalence of Adverse Drug Reactions (ADRs) in high-risk pregnant women after hospital admission. A prospective study was carried out in a teaching maternity hospital in Brazil during six months. Causality of ADRs was assessed through the Naranjo Algorithm and Korean Algorithm for ADR Causality Assessment. Severity of ADRs was assessed using Hartwig’s Severity Assessment Scale. The prevalence of ADRs among the 294 inpatients studied was 8.8%. The mean age was 27.14 (±7.5) y.o. Patient's age was related to the presence of ADRs, while the manifestation of these events was not associated with any adverse pregnancy outcome. 75.9% of the ADRs reported in the study were of mild severity and 24.1% were of moderate severity. No ADR was caused by drug-drug interaction; however, a significant increase in blood pressure was observed in all patients using concurrent methyldopa and ferrous sulfate. Overall, ADRs were not common events among high-risk pregnant women and no adverse pregnancy outcomes following these events were observed.
ISSN:1319-0164
2213-7475
DOI:10.1016/j.jsps.2017.01.005