Use of tramadol in early pregnancy and congenital malformation risk

Källén, Bëngt; Reis, Margareta

doi:10.1016/j.reprotox.2015.10.007

Cited by 38 publications

(28 citation statements)

References 14 publications

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“…12,15,52,55,87 In 2 studies by Källén et al, 12,52 tramadol exposure in early pregnancy was associated with a statistically significant increased risk of clubfoot. Källén and Reis 52 also reported an increased risk of congenital malformations overall, “relatively severe malformations” (authors excluded preauricular appendix, tongue tie, patent ductus arteriosus in preterm infants, single umbilical artery, undescended testicle, unstable hip or hip (sub) luxation, and nevus), heart malformations overall, and isolated cardiac septum malformations with tramadol exposure in early pregnancy, as well as congenital malformations overall, and “relatively severe malformations” with codeine exposure and an increased risk of heart malformations overall with the use of synthetic opioids in early pregnancy. The remaining 3 studies evaluated associations with methadone exposure; all studies reported an increased risk of malformations overall.…”

Section: Resultsmentioning

confidence: 99%

“…Ten studies did not calculate risk estimates of congenital malformations in infants exposed to opioids, 13,24,41,45,51,74,80,81,85,85 and in 5 studies, no congenital malformations were reported in any infant. 25,25,57,78,84 Of the remaining 18 cohort studies that performed statistical tests to measure associations, 12,15–,21,47,52,53,56,63,65,66,76,77,87,88 7 reported statistically significant increased risks of congenital malformations as a result of prenatal opioid exposure. 12,15,19,21,52,55,87 Four of the 7 studies assessed associations with opioid exposure in aggregate, 12,19,21,55 reporting a statistically significant increased risk of congenital malformations overall in 3 studies 19,21,55 and clubfoot (pes equinovarus) in 1 study.…”

Section: Resultsmentioning

confidence: 99%

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Maternal Use of Opioids During Pregnancy and Congenital Malformations: A Systematic Review

et al. 2017

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CONTEXT Opioid use and abuse have increased dramatically in recent years, particularly among women. OBJECTIVES We conducted a systematic review to evaluate the association between prenatal opioid use and congenital malformations. DATA SOURCES We searched Medline and Embase for studies published from 1946 to 2016 and reviewed reference lists to identify additional relevant studies. STUDY SELECTION We included studies that were full-text journal articles and reported the results of original epidemiologic research on prenatal opioid exposure and congenital malformations. We assessed study eligibility in multiple phases using a standardized, duplicate review process. DATA EXTRACTION Data on study characteristics, opioid exposure, timing of exposure during pregnancy, congenital malformations (collectively or as individual subtypes), length of follow-up, and main findings were extracted from eligible studies. RESULTS Of the 68 studies that met our inclusion criteria, 46 had an unexposed comparison group; of those, 30 performed statistical tests to measure associations between maternal opioid use during pregnancy and congenital malformations. Seventeen of these (10 of 12 case-control and 7 of 18 cohort studies) documented statistically significant positive associations. Among the case-control studies, associations with oral clefts and ventricular septal defects/atrial septal defects were the most frequently reported specific malformations. Among the cohort studies, clubfoot was the most frequently reported specific malformation. LIMITATIONS Variabilities in study design, poor study quality, and weaknesses with outcome and exposure measurement. CONCLUSIONS Uncertainty remains regarding the teratogenicity of opioids; a careful assessment of risks and benefits is warranted when considering opioid treatment for women of reproductive age.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Maternal Use of Opioids During Pregnancy and Congenital Malformations: A Systematic Review

et al. 2017

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“…Although tramadol was detected in one dyad only, our findings also indicate that tramadol possesses a distinct placental permeability with similar tramadol levels in maternal and umbilical cord plasma. Teratogenic effects of tramadol have been described, but the risk increase appeared to be moderate [23].…”

Section: Discussionmentioning

confidence: 99%

Detection of drugs in paired maternal and umbilical cord blood samples

Veit¹,

Erdmann²,

Birngruber³

et al. 2017

RJLM

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Objectives. The consumption of drugs during pregnancy or delivery leads to pre and intranatal drug exposure of the fetus. The purpose of this study was to examine paired blood samples of the mother and the umbilical cord regarding drug distribution. Methods. Over a period of two years, 22 pregnant women with known or admitted drug use were selected. Paired blood samples of the mothers and the umbilical cord blood were collected shortly before and during birth/caesarean section, respectively. The samples were subjected to systematic immunochemical, HPLC-DAD, GC/MS and LC-MS/MS analysis and compared regarding presence of drugs. Results. Methadone, THC-COOH, tramadol, benzoylecgonine, citalopram, carbamazepine, lamotrigine, perazine, methylphenidate, quetiapine, ranitidine and most constituents of spinal and epidural anaesthesia were found in both, maternal and umbilical cord blood samples. THC, 11-OH-THC, olanzapine, diphenhydramine and telmisartan were found in maternal blood only. Conclusions. As previously shown a variety of drugs is able to pass the placenta of pregnant woman. Umbilical cord blood appears to be a viable matrix for the detection of maternal drug consumption. Drugs administered during labour and birth could be detected in umbilical cord blood. Further studies with a greater collective of women with known drug use including analyses of fetal/infant samples will yield additional information in the future.

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“…Several studies have shown that the use of opioids during pregnancy increases the risk for birth abnormalities such as neural tube defects, gastroschisis, congenital heart defects, clubfoot, and neonatal abstinence syndrome . However, data on use of opioids during pregnancy and delivery outcomes is scarce.…”

Section: Introductionmentioning

confidence: 99%

“…4,[8][9][10][11] Several studies have shown that the use of opioids during pregnancy increases the risk for birth abnormalities such as neural tube defects, gastroschisis, congenital heart defects, clubfoot, and neonatal abstinence syndrome. 8,[12][13][14] However, data on use of opioids during pregnancy and delivery outcomes is scarce. A Norwegian study observed that self-reported codeine used anytime during pregnancy was associated with an increased risk for planned caesarean sections, and codeine used in the third trimester of pregnancy was associated with acute caesarean sections and postpartum haemorrhage.…”

Section: Introductionmentioning

confidence: 99%

Use of opioids during pregnancy and effects of pregnancy outcomes

Fältmarch

Perttilä

Tuomi

et al. 2019

Pharmacoepidemiology and Drug

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Purpose To evaluate the use of opioids in pregnant primiparous women and study the effect of opioid use on maternal and offspring delivery outcomes. Methods The study cohort (N = 6231) consists of all primiparous women with a Finnish background who delivered a singleton between 2009 and 2015 in the city of Vantaa, Finland. Data on births, maternal characteristics, pregnancy outcomes, and purchases of prescription drugs were obtained from National Health Registers. Results Of the primiparous women, 5.1% used opioids during pregnancy. Of these, 95.9% used codeine. No differences were observed in purchases of opioids between the different trimesters but more women purchased opioids as pregnancy progressed (.002). Users of opioids more often also purchased other prescription drugs compared with non‐users of opioids, 89% versus 58% (P < .001); age, smoking, education, and body mass index adjusted odds ratio 5.66 (95% confidence interval 3.96 to 8.09). Caesarean sections were more common in users of opioids than in non‐users, 28.3% versus 21.9% (.007). Before the age of 7 days, the offspring of users of opioids more often needed respirator treatment compared with the offspring of non‐users, 3.1% versus 1.6% (.044). Conclusions One out of 20 pregnant women used opioids. Use of opioids during pregnancy was associated with the risk for deliveries by caesarean sections and need for respiratory treatment among the offspring during the first week of life. Further safety evaluations are needed.

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Use of tramadol in early pregnancy and congenital malformation risk

Cited by 38 publications

References 14 publications

Maternal Use of Opioids During Pregnancy and Congenital Malformations: A Systematic Review

Maternal Use of Opioids During Pregnancy and Congenital Malformations: A Systematic Review

Detection of drugs in paired maternal and umbilical cord blood samples

Use of opioids during pregnancy and effects of pregnancy outcomes

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