Tatiana Xavier da Costa1,2,3, Marta Danielle de Almeida Pimenta Cunha4,5, Priscilla Karilline do Vale Bezerra4, Francine Johansson Azeredo6, Rand Randall Martins7, Antonio Gouveia Oliveira7. 1. Postgraduate Program in Pharmaceutical Sciences, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, Brazil. tatycx1000@gmail.com. 2. Maternity School Januário Cicco, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, Brazil. tatycx1000@gmail.com. 3. Faculdade de Farmácia, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil. tatycx1000@gmail.com. 4. Postgraduate Program in Pharmaceutical Sciences, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, Brazil. 5. Maternity School Januário Cicco, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, Brazil. 6. Department of Pharmacy, Faculdade de Farmácia, Universidade Federal da Bahia, Salvador, Brazil. 7. Department of Pharmacy, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, Brazil.
Abstract
PURPOSE: To estimate the cumulative incidence of adverse drug reactions (ADRs) in women with high-risk pregnancy hospitalized in an obstetric intensive care unit, then to describe the medicines involved and to identify major risk factors. METHODS: From June 2016 to December 2017, patients admitted to the ICU with high-risk pregnancy were considered eligible in this observational, longitudinal, prospective study. Patients were investigated daily for the occurrence of ADRs through pharmaceutical anamnesis, active search in medical records and questioning of the health team. Suspected ADRs were classified according to Naranjo's algorithm. Written informed consent was obtained from all patients. Univariate and multivariate logistic regression were used to identify risk factors of ADR. RESULTS: The study population consisted of 607 high-risk pregnancies from 851 women admitted to the ICU, of whom 244 admitted for non-obstetric conditions, with an ICU stay less than 24 h or readmitted to the ICU were excluded. The mean age was 27.0 ± 7.5 years-old, mean gestational age was 33.8 ± 6.3 weeks. ADR were observed in 165 women (27.2%). No severe ADR was observed and 29.7% were of moderate severity. The most often implicated medicine was magnesium sulphate (25.2%) with 44.5% of patients administered that substance experiencing ADRs consisting of somnolence (68.6%), absent patellar reflex (21.6%) and hypotension (9.8%). Risk factors of ADR were blood pressure (adjusted odds-ratio (aOR) 1.02), haemoglobin level (aOR 1.21) and body temperature (aOR 0.71). CONCLUSIONS: ADRs affect about one third of high-risk pregnancies, mainly due to magnesium sulphate administrations. High blood pressure, lower body temperature, and high haemoglobin concentration on admission were associated with an increased risk of ADR.
PURPOSE: To estimate the cumulative incidence of adverse drug reactions (ADRs) in women with high-risk pregnancy hospitalized in an obstetric intensive care unit, then to describe the medicines involved and to identify major risk factors. METHODS: From June 2016 to December 2017, patients admitted to the ICU with high-risk pregnancy were considered eligible in this observational, longitudinal, prospective study. Patients were investigated daily for the occurrence of ADRs through pharmaceutical anamnesis, active search in medical records and questioning of the health team. Suspected ADRs were classified according to Naranjo's algorithm. Written informed consent was obtained from all patients. Univariate and multivariate logistic regression were used to identify risk factors of ADR. RESULTS: The study population consisted of 607 high-risk pregnancies from 851 women admitted to the ICU, of whom 244 admitted for non-obstetric conditions, with an ICU stay less than 24 h or readmitted to the ICU were excluded. The mean age was 27.0 ± 7.5 years-old, mean gestational age was 33.8 ± 6.3 weeks. ADR were observed in 165 women (27.2%). No severe ADR was observed and 29.7% were of moderate severity. The most often implicated medicine was magnesium sulphate (25.2%) with 44.5% of patients administered that substance experiencing ADRs consisting of somnolence (68.6%), absent patellar reflex (21.6%) and hypotension (9.8%). Risk factors of ADR were blood pressure (adjusted odds-ratio (aOR) 1.02), haemoglobin level (aOR 1.21) and body temperature (aOR 0.71). CONCLUSIONS:ADRs affect about one third of high-risk pregnancies, mainly due to magnesium sulphate administrations. High blood pressure, lower body temperature, and high haemoglobin concentration on admission were associated with an increased risk of ADR.
Entities:
Keywords:
Adverse drug reactions; High-risk pregnancy; Intensive care; Magnesium sulphate
Authors: C A Naranjo; U Busto; E M Sellers; P Sandor; I Ruiz; E A Roberts; E Janecek; C Domecq; D J Greenblatt Journal: Clin Pharmacol Ther Date: 1981-08 Impact factor: 6.875
Authors: Dawn Gano; Mai-Lan Ho; John Colin Partridge; Hannah C Glass; Duan Xu; A James Barkovich; Donna M Ferriero Journal: J Pediatr Date: 2016-07-22 Impact factor: 4.406
Authors: A Lupattelli; O Spigset; M J Twigg; K Zagorodnikova; A C Mårdby; M E Moretti; M Drozd; A Panchaud; K Hämeen-Anttila; A Rieutord; R Gjergja Juraski; M Odalovic; D Kennedy; G Rudolf; H Juch; A Passier; I Björnsdóttir; H Nordeng Journal: BMJ Open Date: 2014-02-17 Impact factor: 2.692