Abstract Number: OC 11.1
Meeting: ISTH 2020 Congress
Background: Exposure of pregnant women to vitamin-K antagonists (VKA) carries a high risk for embroypathy (at least 7%), but for direct oral anticoagulants (DOAC) the embryopathy risk is still unknown.
Aims: We aimed to evaluate pregnancy outcomes after DOAC exposure using data from various sources.
Methods: Cases of DOAC pregnancy exposure were collected from literature search, from questionnaires sent to German gynecologists, obstetricians and hematologists and from pharmacovigilance databases with the DOAC manufacturers, the German drug authority (BfArM) and the European Medicines Agencies (EMA).
Results: A total of 1084 exposure reports were identified and, after removing duplicates, 588 (likely separate) cases of DOAC exposure in pregnancy could be identified. A main limitation was the lack of details and insufficient follow-up data in the datasets provided by DOAC manufacturers and authorities.
Information of pregnancy outcome was available in 313/588 cases (53.2%; figure 1) and consisted of 172 live births (55.0%); 69 miscarriages (22.0%); 72 elective pregnancy interruptions (23.0%). In 1 case, the pregnancy was still ongoing. In 273 cases (46.4%) no outcome data were available.
In the 313 pregnancies with reported outcomes 19 abnormalities were reported (6.1%) of which 12 could potentially be related to DOAC exposure (figure 1; highlighted in red bold italic), which would translate into an overall embryopathy risk of 3.8%. Within the 172 live births, abnormalities occurred in 12 cases and 9 were rated as potential embryotoxicity (5.2%).
Conclusions: Currently available data suggest that the risk for DOAC embryopathy is lower than that reported for VKA exposure. Still, despite increasing case numbers, pregnancy outcomes are insufficiently reported and significant data gaps remain. Pregnancy has to be consequently avoided in DOAC patients, but available data do not justify pregnancy termination based on DOAC exposure alone. Instead, non-directive counselling, close pregnancy surveillance and outcome reporting to pharmacovigilance is recommended.
To cite this abstract in AMA style:Beyer-Westendorf J, Naue C, Tittl L, Marten S. Outcome of DOAC Exposure during Pregnancy (…and the Problem of Event Reporting…) [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/outcome-of-doac-exposure-during-pregnancy-%c2%85and-the-problem-of-event-reporting%c2%85/. Accessed December 2, 2021.
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