This article examines the pharmacological aspects of drug administration during pregnancy and lactation. Special attention is paid to physiological changes occurring in the maternal organism, pharmacokinetic and pharmacodynamic alterations of medications, placental drug transfer mechanisms, fetal risks associated with teratogenicity, and the safety of medicines during breastfeeding. Evidence-based approaches for evaluating the risk-benefit ratio of pharmacotherapy in pregnant and lactating women are discussed. The article also analyzes international recommendations concerning the rational and safe use of drugs in obstetric and neonatal practice. Current scientific findings demonstrate that inappropriate medication use during pregnancy may lead to congenital malformations, fetal toxicity, developmental disorders, and neonatal complications, while rational pharmacotherapy significantly improves maternal and fetal outcomes. The study emphasizes the importance of individualized pharmacological management, evidence-based prescribing, and careful monitoring during pregnancy and lactation.

Pregnancy, lactation, pharmacology, teratogenicity, placental transfer, breast milk, pharmacokinetics, fetal toxicity, maternal health, drug safety, breastfeeding, pharmacotherapy.

Briggs G.G., Freeman R.K., Towers C.V., Forinash A.B. Drugs in Pregnancy and Lactation. 12th ed. Philadelphia: Wolters Kluwer, 2021. pp. 15–32.

Mitchell A.A., Gilboa S.M., Werler M.M. et al. Medication use during pregnancy. American Journal of Obstetrics and Gynecology. 2011;205(1):51.e1–51.e8. pp. 51–55.

Shields K.E., Lyerly A.D. Exclusion of pregnant women from industry-sponsored clinical trials. Obstetrics & Gynecology. 2013;122(5):1077–1081. pp. 1078–1080.

Syme M.R., Paxton J.W., Keelan J.A. Drug transfer and metabolism by the human placenta. Clinical Pharmacokinetics. 2004;43(8):487–514. pp. 490–498.

Schaefer C., Peters P., Miller R.K. Drugs During Pregnancy and Lactation. 3rd ed. Academic Press, 2015. pp. 45–68.

Kim J.H., Scialli A.R. Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicological Sciences. 2011;122(1):1–6. pp. 1–4.

Anderson P.O. Drugs in lactation. Pharmacotherapy. 2018;38(3):355–356. pp. 355–356.

World Health Organization. Breastfeeding and Maternal Medication: Recommendations for Drugs in the WHO Model List of Essential Drugs. Geneva: WHO, 2002. pp. 5–19.

Costantine M.M. Physiologic and pharmacokinetic changes in pregnancy. Frontiers in Pharmacology. 2014;5:65. pp. 66–70.

Dawes M., Chowienczyk P.J. Drugs in pregnancy: pharmacokinetics in pregnancy. Best Practice & Research Clinical Obstetrics & Gynaecology. 2001;15(6):819–826. pp. 820–822.

Tracy T.S., Venkataramanan R., Glover D.D., Caritis S.N. Temporal changes in drug metabolism during pregnancy. Expert Opinion on Drug Metabolism & Toxicology. 2005;1(4):631–653. pp. 635–641.

Koren G., Pastuszak A., Ito S. Drugs in pregnancy. New England Journal of Medicine. 1998;338(16):1128–1137. pp. 1130–1134.

U.S. Food and Drug Administration. Pregnancy and Lactation Labeling Rule (PLLR). Silver Spring: FDA, 2015. pp. 1–12.

Rowe H., Baker T., Hale T.W. Maternal medication, drug use, and breastfeeding. Pediatric Clinics of North America. 2013;60(1):275–294. pp. 278–286.

Sachs H.C. The transfer of drugs and therapeutics into human breast milk. Pediatrics. 2013;132(3):e796–e809. pp. e799–e805.

Nahum G.G., Uhl K., Kennedy D.L. Antibiotic use in pregnancy and lactation. Obstetrics & Gynecology. 2006;107(5):1120–1138. pp. 1125–1130.

Berle J.O., Spigset O. Antidepressant use during breastfeeding. Current Women’s Health Reviews. 2011;7(1):28–34. pp. 30–32.

Tomson T., Battino D. Teratogenic effects of antiepileptic medications. Neurologic Clinics. 2009;27(4):993–1002. pp. 995–999.

Pennell P.B. Antiepileptic drug pharmacokinetics during pregnancy and lactation. Neurology. 2003;61(6 Suppl 2):S35–S42. pp. S37–S40.

Goldenberg R.L., Culhane J.F. Infection as a cause of preterm birth. Clinical Perinatology. 2003;30(4):677–700. pp. 680–686.

Bookstaver P.B., Bland C.M., Griffin B. et al. A review of antibiotic use in pregnancy. Pharmacotherapy. 2015;35(11):1052–1062. pp. 1058–1060.

Bullo M., Tschumi S., Bucher B.S. et al. Pregnancy outcome following exposure to ACE inhibitors. Hypertension. 2012;60(2):444–450. pp. 446–448.

Magee L.A., von Dadelszen P. State-of-the-art diagnosis and treatment of hypertension in pregnancy. Mayo Clinic Proceedings. 2018;93(11):1664–1677. pp. 1668–1672.

Bonari L., Pinto N., Ahn E. et al. Perinatal risks of untreated depression during pregnancy. Canadian Journal of Psychiatry. 2004;49(11):726–735. pp. 728–731.

Moses-Kolko E.L., Bogen D., Perel J. et al. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors. JAMA. 2005;293(19):2372–2383. pp. 2375–2378.

Greer I.A. Thrombosis in pregnancy. Journal of Thrombosis and Haemostasis. 2015;13(S1):S293–S298. pp. S294–S296.

Madadi P., Koren G., Cairns J. et al. Safety of codeine during breastfeeding. Canadian Family Physician. 2007;53(1):33–35. pp. 33–34.

World Health Organization. WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: WHO, 2016. pp. 152–165.

Haas D.M., Marsh D.J., Dang D.T. Pharmacogenomics and individualized therapy during pregnancy. Seminars in Perinatology. 2014;38(8):508–518. pp. 510–514.