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de Oliveira-Filho AD, Vieira AES, da Silva RC, et al. Adverse drug reactions in high-risk pregnant women: A prospective study. Saudi Pharm J. 2017;25(7):1073-1077doi: 10.1016/j.jsps.2017.01.005.
de Oliveira-Filho, A. D., Vieira, A. E. S., da Silva, R. C., Neves, S. J. F., Gama, T. A. B., Lima, R. V., Oliveira, W. R., & de Gonçalves Dias, J. M. (2017). Adverse drug reactions in high-risk pregnant women: A prospective study. Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society, 25(7), 1073-1077. https://doi.org/10.1016/j.jsps.2017.01.005
de Oliveira-Filho, Alfredo Dias, et al. "Adverse drug reactions in high-risk pregnant women: A prospective study." Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society vol. 25,7 (2017): 1073-1077. doi: https://doi.org/10.1016/j.jsps.2017.01.005
de Oliveira-Filho AD, Vieira AES, da Silva RC, Neves SJF, Gama TAB, Lima RV, Oliveira WR, de Gonçalves Dias JM. Adverse drug reactions in high-risk pregnant women: A prospective study. Saudi Pharm J. 2017 Nov;25(7):1073-1077. doi: 10.1016/j.jsps.2017.01.005. Epub 2017 Feb 02. PMID: 29158717; PMCID: PMC5681315.
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Saudi Pharm J. 2017 Nov;25(7):1073-1077. doi: 10.1016/j.jsps.2017.01.005. Epub 2017 Feb 02.

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

Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society

Alfredo Dias de Oliveira-Filho, Antonio Emanuel Soares Vieira, Roberta Cruz da Silva, Sabrina Joany Felizardo Neves, Thiago Antonio Barros Gama, Ryane Vieira Lima, Wlisses Ramon Oliveira, Júlia Maria de Gonçalves Dias

Affiliations

  1. Núcleo de Estudos em Farmacoterapia (NEF), School of Nursing and Pharmacy (ESENFAR), Federal University of Alagoas, Brazil.
  2. Department of Medicine, Federal University of Sergipe, Brazil.

PMID: 29158717 PMCID: PMC5681315 DOI: 10.1016/j.jsps.2017.01.005

Abstract

BACKGROUND: 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.

OBJECTIVE: 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.

RESULTS: 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.

CONCLUSION: Overall, ADRs were not common events among high-risk pregnant women and no adverse pregnancy outcomes following these events were observed.

Keywords: Adverse drug reactions; Drug-drug interactions; Ferrous sulfate; High-risk pregnancy; Maternal age; Methyldopa; Prevalence

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