Safety of direct oral anticoagulant exposure during pregnancy: a retrospective cohort study

Making gender bias visible allows to fill the gaps in knowledge and understand health records and risks of women and men. The coronavirus disease 2019 (COVID-19) pandemic has shown a clear gender difference in health outcomes. The more severe symptoms and higher mortality in men as compared to women are likely due to sex and age differences in immune responses. Age-associated decline in sex steroid hormone levels may mediate proinflammatory reactions in older adults, thereby increasing their risk of adverse outcomes, whereas sex hormones and/or sex hormone receptor modulators may attenuate the inflammatory response and provide benefit to COVID-19 patients. While multiple pharmacological options including anticoagulants, glucocorticoids, antivirals, anti-inflammatory agents and traditional Chinese medicine preparations have been tested to treat COVID-19 patients with varied levels of evidence in terms of efficacy and safety, information on sex-targeted treatment strategies is currently limited. Women may have more benefit from COVID-19 vaccines than men, despite the occurrence of more frequent adverse effects, and long-term safety data with newly developed vectors are eagerly awaited. The prevalent inclusion of men in randomised clinical trials (RCTs) with subsequent extrapolation of results to women needs to be addressed, as reinforcing sex-neutral claims into COVID-19 research may insidiously lead to increased inequities in health care. The huge worldwide effort with over 3,000 ongoing RCTs of pharmacological agents should focus on improving knowledge on sex, gender and age as pillars of individual variation in drug responses and enforce appropriateness.

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“…Pregnancy or breastfeeding are contraindications to DOAC therapy [177] , thus heparin would be the drug of choice in this case.…”

Section: Pregnancy and Covid-19mentioning

confidence: 99%

Sex-tailored pharmacology and COVID-19: Next steps towards appropriateness and health equity

Spini

Giudice

Brancaleone

et al. 2021

Pharmacological Research

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“…Vitamin K antag o nists are not recommended in preg nancy due to known ter a to ge nic ity, and direct oral anti co ag u lants still have lim ited safety infor ma tion (with an International Society on Thrombosis and Haemostasis reg is try ongo ing). 37,38 Side effects of LMWH use dur ing pregnancy include a small risk of impor tant bleed ing antepartum (~0.5%), injec tion site bruis ing and reac tions, and a very rare pos si bil ity of hep a rin-induced throm bo cy to pe nia. 39 Unlike UFH, pro phy lac tic or inter me di ate-dose LMWH does not reduce bone min eral den sity dur ing preg nancy, but less data are avail able for ther a peu tic doses.…”

Section: Clinical Casementioning

confidence: 99%

“…43 As preg nancy advances, there is an increased vol ume of distri bu tion and glo mer u lar fil tra tion rate, so there is the potential for increased clear ance of LMWH. 38,44 Because of these preg nancy-spe cific changes, there remains con tro versy on the use of once-vs twice-daily LMWH dos ing and the role of anti-Xa level mon i tor ing of LMWH. In a 2014 Cana dian sur vey of 69 hema tol o gists, inter nists, and obste tri cians, there was con sider able prac tice var i a tion in acute VTE man age ment.…”

Section: Clinical Casementioning

confidence: 99%

Prevention and management of venous thromboembolism in pregnancy: cutting through the practice variation

Skeith

2021

Hematology

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There is clinical practice variation in the area of prevention and management of venous thromboembolism (VTE) in pregnancy. There are limited data and differing recommendations across major clinical practice guidelines, especially relating to the role of postpartum low-molecular-weight heparin (LMWH) for patients with mild inherited thrombophilia and those with pregnancy-related VTE risk factors. This chapter explores the issues of practice variation and related data for postpartum VTE prevention. Controversial topics of VTE management in pregnancy are also reviewed and include LMWH dosing and the role of anti-Xa level monitoring, as well as peripartum anticoagulation management around labor and delivery.

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“…To close this gap in knowledge, an extensive review of documented DOAC exposures in pregnancies was recently performed, summarizing data from the literature, from dedicated registries, from single case reports obtained directly from treating physicians, and from pharmacovigilance systems of drug authorities and DOAC manufacturers. 61 From a total of 1193 reports including duplicates, 614 unique cases could be identified, with information on pregnancy outcome available for 336 cases: 188 live births, 74 miscarriages, and 74 elective pregnancy terminations. In this data set, reported birth anomalies were adjudicated by two independent teratology experts.…”

Section: Pre Venting or Pl Anning Preg Nan Cie S During Doac Ther Apy And The Ris K Of Doac E Xp Osure In Preg Nan C Ymentioning

confidence: 99%

Reproductive issues in women on direct oral anticoagulants

Beyer‐Westendorf

Marten

2021

Research and Practice in Thrombosis and Haemostasis

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Direct oral anticoagulants (DOACs) are replacing warfarin and other vitamin K antagonists for a wide range of indications. Advantages of DOAC therapy are fewer food and drug interactions and fixed dosing without routine laboratory monitoring, making DOACs the perfect choice especially for younger patients, in whom the main indication for anticoagulation is prevention and treatment of venous thromboembolism (VTE). Although DOACs are safer and much more convenient than other anticoagulant alternatives, their profile may have drawbacks, especially for younger female patients in whom reproductive issues need special considerations. These may include the issue of heavy menstrual bleeding (HMB) during anticoagulant therapy, the embryotoxicity risk from inadvertent DOAC exposure during pregnancy, and the prevention or planning of pregnancies during DOAC therapy. This review summarizes the most relevant evidence in this increasingly important field of women’s health.

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Safety of direct oral anticoagulant exposure during pregnancy: a retrospective cohort study

Cited by 41 publications

References 31 publications

Sex-tailored pharmacology and COVID-19: Next steps towards appropriateness and health equity

Sex-tailored pharmacology and COVID-19: Next steps towards appropriateness and health equity

Prevention and management of venous thromboembolism in pregnancy: cutting through the practice variation

Reproductive issues in women on direct oral anticoagulants

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