Risk estimation of fetal adverse effects after short-term second trimester exposure to non-steroidal anti-inflammatory drugs: a literature review

Dathe, Katarina; Hultzsch, Stefanie; Pritchard, Lucas William; Schaefer, Christof

doi:10.1007/s00228-019-02712-2

Cited by 30 publications

(13 citation statements)

References 42 publications

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“…The risk of indomethacin-induced fetal ductal constriction increases with advancing gestational age ( Luchese et al, 2003 ). Second trimester fetal adverse events have been reported after prolonged NSAID exposure of at least 7 days while our case reports the occurrence of DA narrowing after two topical applications of a daily NSAID patch (48 h of total application) ( Dathe et al, 2019 ).…”

Section: Discussionmentioning

confidence: 79%

Case Report: Persistent Pulmonary Hypertension of the Newborn and Narrowing of the Ductus Arteriosus After Topical Use of Non-Steroidal Anti-Inflammatory During Pregnancy

et al. 2021

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Background: The use of non-steroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy can cause premature constriction of the ductus arteriosus. This report describes a case of in utero narrowing of the ductus arteriosus (DA) diagnosed postnatally in a baby with Persistent Pulmonary Hypertension of the Newborn (PPHN), after maternal use of Diclofenac-Epolamine 140 mg patch during the second and third trimester.Case Presentation: A fetal ultrasounds revealed an enlarged hypertrophic right ventricle at 32 weeks of gestation. Detailed questioning of the mother highlighted that topical Diclofenac (FLECTOR®) had been used at 26 and at 31 weeks of gestation. An echocardiography performed 8 h postnatally showed supra-systemic pulmonary hypertension, a restrictive ductus arteriosus and a dilated right ventricle. The newborn was treated by inhaled nitric oxide and oral Sildenafil and was discharged from hospital on day 24. He had a complete normalization of his pulmonary vascular resistance on day 48.Conclusion: This case illustrates the potential fetal and neonatal complications associated with maternal topical Diclofenac medication during pregnancy resulting in antenatal closure of the DA.

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Section: Discussionmentioning

confidence: 79%

Case Report: Persistent Pulmonary Hypertension of the Newborn and Narrowing of the Ductus Arteriosus After Topical Use of Non-Steroidal Anti-Inflammatory During Pregnancy

et al. 2021

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“…Most of the risk medications used belong to the FDA's category C, including scopolamine and metamizole in combination or alone. Metamizole is the analgesic most consumed by pregnant women in Brazil; however, its commercialization is prohibited in some European countries and the United States due to associations with serious adverse events, for this reason, the literature recommends the use of acetaminophen for analgesia during pregnancy (Couto et al, 2015;Dathe et al, 2019;Toda, 2017).…”

Section: Discussionmentioning

confidence: 99%

Drug use according to risk classification and associated factors among pregnant women: results from NISAMI cohort

Costa

Castro

Gama

et al. 2020

RSD

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This study aimed to investigate the factors associated with drug use in pregnancy by risk categories in pregnant women from Santo Antônio de Jesus, Bahia. It is a cross-sectional cohort study with 1,091 pregnant women attended in primary health care between 2012 and 2014. Drug use during pregnancy was classified according to the FDA’s pregnancy risk classification. Prevalence ratios and respective 95% confidence intervals were adjusted by Poisson regression with robust error variance. The prevalence of drug use was more pronounced in risk categories A, B, C, D, and X, respectively. The use of safe medication was associated with education, number of prenatal consultations, and health problems after data adjustment. Age greater than 24 years, onset of prenatal care during the first trimester, and have any health problem were factors associated with the use of risk medication. Quality prenatal care is important to ensure the safe and conscious use of drugs. Furthermore, investments in continuing vocational education that promote rational antenatal drug use are needed.

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“…Due to their well-known fetotoxic risks, NSAID and metamizole should not be used during the 3rd trimester [8][9][10][11][12]. In addition, there are several reports describing fetal adverse effects after NSAID therapy in the advanced 2nd trimester [13]. However, the magnitude of this risk has not been sufficiently investigated yet.…”

Section: Introductionmentioning

confidence: 99%

Fetal adverse effects following NSAID or metamizole exposure in the 2nd and 3rd trimester: an evaluation of the German Embryotox cohort

Dathe

Frank

Padberg

et al. 2022

BMC Pregnancy Childbirth

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Background Non-steroidal anti-inflammatory drugs (NSAID) are frequently used to treat pain, fever and inflammatory conditions. Due to evidenced fetotoxicity, treatment with NSAID and metamizole should be avoided in the 3rd trimester of pregnancy. There is an ongoing debate on fetotoxic risk of 2nd trimester use which is why we have conducted this study. Methods In this observational cohort study outcome of pregnancies with NSAID and/or metamizole exposure in the 2nd and/or 3rd trimester (study cohort n = 1092) was compared with pregnancies exposed to NSAID and/or metamizole in the 1st trimester only (comparison cohort, n = 1154). The WHO-UMC system was used to assess causality between study medication and study endpoints. Prenatal study endpoints were constriction of ductus arteriosus Botalli, oligohydramnios, late spontaneous abortion (SAB) or stillbirth. Postnatal study endpoints were patent ductus arteriosus (PDA), anomalies of the right heart ventricle, primary pulmonary hypertension (PPHT), and neonatal impairment of kidney function. Results Ductus arteriosus constriction was diagnosed in 5/1092 (0.5%) in the study cohort versus 0/1154 pregnancies in the comparison cohort. In one fetus, ductus arteriosus constriction and oligohydramnios occurred already in the late 2nd trimester after long-term NSAID exposure. Oligohydramnios was diagnosed in 41/1092 (3.8%) in the study cohort versus 29/1154 (2.5%) cases in the comparison cohort [RR, 1.5 (95% CI 0.9–2.4)]. Limited to 2nd trimester, oligohydramnios occurred in 8/904 (0.9%) versus 2/1154 (0.2%) pregnancies [RR, 5.1 (95% CI 1.1–24.0)]. At least in four of the 2nd trimester exposed pregnancies NSAID exposure lasted several weeks. Late SAB or stillbirth occurred in 14/1092 (1.3%) versus 17/1154 (1.5%). Postnatal cardiovascular or renal pathology did not differ between the cohorts. Conclusions NSAID use in the 2nd trimester limited to a few days does not appear to pose a relevant risk. Use for longer periods in the advanced 2nd trimester, however, may cause oligohydramnios and ductus arteriosus constriction similar to effects observed after 3rd trimester use.

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Risk estimation of fetal adverse effects after short-term second trimester exposure to non-steroidal anti-inflammatory drugs: a literature review

Cited by 30 publications

References 42 publications

Case Report: Persistent Pulmonary Hypertension of the Newborn and Narrowing of the Ductus Arteriosus After Topical Use of Non-Steroidal Anti-Inflammatory During Pregnancy

Case Report: Persistent Pulmonary Hypertension of the Newborn and Narrowing of the Ductus Arteriosus After Topical Use of Non-Steroidal Anti-Inflammatory During Pregnancy

Drug use according to risk classification and associated factors among pregnant women: results from NISAMI cohort

Fetal adverse effects following NSAID or metamizole exposure in the 2nd and 3rd trimester: an evaluation of the German Embryotox cohort

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