Does the average drug exposure in pregnant women affect pregnancy outcome? A comparison of two approaches to estimate the baseline risks of adverse pregnancy outcome

Wacker, Evelin; Navarro, Ana; Meister, Reinhard; Padberg, Stephanie; Weber-Schoendorfer, Corinna; Schaefer, Christof

doi:10.1002/pds.3744

Cited by 15 publications

(10 citation statements)

References 22 publications

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“…Therefore, the control group does not necessarily represent the general pregnant population but rather a subset of particularly concerned and/or health-oriented patients with non-teratogenic drug exposure. A recent publication demonstrated that this approach does not substantially bias the results of pregnancy outcome studies [47].…”

Section: Strengths and Limitationsmentioning

confidence: 99%

Pregnancy outcome after TNF‐α inhibitor therapy during the first trimester: a prospective multicentre cohort study

Weber-Schoendorfer

Oppermann

Wacker

et al. 2015

Brit J Clinical Pharma

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132

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Aims TNF‐α inhibitors are considered relatively safe in pregnancy but experience is still limited. The aim of this study was to evaluate the risk of major birth defects, spontaneous abortion, preterm birth and reduced birth weight after first trimester exposure to TNF‐α inhibitors. Methods Pregnancy outcomes of women on adalimumab, infliximab, etanercept, certolizumab pegol or golimumab were evaluated in a prospective observational cohort study and compared with outcomes of a non‐exposed random sample. The samples were drawn from pregnancies identified by institutes collaborating in the European Network of Teratology Information Services. Results In total, 495 exposed and 1532 comparison pregnancies were contributed from nine countries. The risk of major birth defects was increased in the exposed (5.0%) compared with the non‐exposed group (1.5%; adjusted odds ratio (ORadj) 2.2, 95% CI 1.0, 4.8). The risk of preterm birth was increased (17.6%; ORadj 1.69, 95% CI 1.1, 2.5), but not the risk of spontaneous abortion (16.2%; adjusted hazard ratio [HRadj] 1.06, 95% CI 0.7, 1.7). Birth weights adjusted for gestational age and sex were significantly lower in the exposed group compared to the non‐exposed cohort (P = 0.02). As a diseased comparison group was not possible to ascertain, the influence of disease and treatment on birth weight and preterm birth could not be differentiated. Conclusions TNF‐α inhibitors may carry a risk of adverse pregnancy outcome of moderate clinical relevance. Considering the impact of insufficiently controlled autoimmune disease on the mother and the unborn child, TNF‐α inhibitors may nevertheless be a treatment option in women with severe disease refractory to established immunomodulatory drugs.

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Section: Strengths and Limitationsmentioning

confidence: 99%

Pregnancy outcome after TNF‐α inhibitor therapy during the first trimester: a prospective multicentre cohort study

Weber-Schoendorfer

Oppermann

Wacker

et al. 2015

Brit J Clinical Pharma

Self Cite

132

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show abstract

“…The usage of drugs show massive regional variations, hence, different drug utilization patterns can be observed . In comparison with German databases, lower intake was detected in this study . However, most of the drug utilization information was obtained by questionnaires or prescription data and not by bio monitoring as in this study.…”

Section: Discussionmentioning

confidence: 57%

“…3,[12][13][14] In comparison with German databases, lower intake was detected in this study. 6 However, most of the drug utilization information was obtained by questionnaires or prescription data and not by bio monitoring as in this study. All monitoring methods provide pros and cons: recall biases are common in questionnaires leading to false negative results.…”

Section: Discussionmentioning

confidence: 99%

“…[4][5][6] Although adverse effects for some drugs are described as for non-steroidal analgesics such as ibuprofen or acetylsalicylic acid, little is known about prenatal risks and safety for the majority of drugs. [6][7][8] In this context, several studies revealed a high drug intake rate for pregnant women with some studies focusing especially on OTC drugs. For instance, Werler et al showed that over 80% of women take OTC drugs during pregnancy with acetaminophen, aspirin, and ibuprofen as the most commonly used analgesics.…”

Section: Introductionmentioning

confidence: 99%

“…Besides the monitoring of sale volume, epidemiological studies are one approach to gain information about drug intake. 6,[10][11][12][13][14][15] In some cases, these studies do not only provide information about medication but also about medical history, the development of diseases, and the social background of the participants and are hence one good possibility for risk assessment.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Assessment of maternal drug intake by urinary bio monitoring during pregnancy and postpartally until the third perinatal year

Hoeke

Roeder

Bertsche

et al. 2015

Pharmacoepidemiol Drug Saf

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Drug safety in pregnancy: the German Embryotox institute

Dathe¹,

Schaefer

2017

Eur J Clin Pharmacol

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Since 1988, the German Embryotox institute combines individual counselling of pregnant women and their health care providers (HCP) with research on drug safety in pregnancy. In addition, Embryotox offers web-based information which covers the most important and most frequently requested pharmaceutical substances. In contrast to ready-made drug risk information in package leaflets and other product information, individual counselling considers different clinical settings such as (1) looking for a drug of choice or planning pregnancy under medication, (2) risk assessment of a particular drug that has already been taken during an (unplanned) pregnancy and (3) evaluation of an adverse pregnancy outcome in association with a particular medication. Using the three established developmental toxicants valproic acid, isotretinoin, and renin-angiotensin-aldosterone system (RAAS) inhibitors as an example, the need of detailed information is illustrated. Through the risk communication process, pregnancy outcome data are routinely collected by Embryotox. This approach uses the advantages of a pre-existing communication structure and of dealing with motivated responders. Engagement in the treatment plan facilitates receiving reliable data on drug exposure as well as detailed follow-up data. Based on these patient records, prospective datasets are evaluated in observational cohort studies in comparison to non-exposed control cohorts. In addition, retrospective datasets received as suspected adverse drug reactions from multiple German sources allow a screening for signals of teratogenicity and distinct patterns of developmental toxicity. Clinical expertise in specialties such as teratology, paediatrics, embryology, obstetrics and human genetics are required to ensure high-quality assessment of drug safety in pregnancy.

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Does the average drug exposure in pregnant women affect pregnancy outcome? A comparison of two approaches to estimate the baseline risks of adverse pregnancy outcome

Cited by 15 publications

References 22 publications

Pregnancy outcome after TNF‐α inhibitor therapy during the first trimester: a prospective multicentre cohort study

Pregnancy outcome after TNF‐α inhibitor therapy during the first trimester: a prospective multicentre cohort study

Assessment of maternal drug intake by urinary bio monitoring during pregnancy and postpartally until the third perinatal year

Drug safety in pregnancy: the German Embryotox institute

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