Zasady dotyczące bezpieczeństwa leków stosowanych w czasie ciąży i laktacji Artykuł przeglądowy
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Opublikowane:
cze 30, 2021
Słowa kluczowe:
ciąża, farmakoterapia, klasyfikacja, laktacja, niemowlę, płód
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Abstrakt
Stosowanie leków w czasie ciąży często jest bardzo skomplikowane i przysparza wielu problemów i wątpliwości. Odpowiednie doświadczenie i wiedza lekarza oraz znajomość aktualnych doniesień naukowych pozwalają ocenić stosunek korzyści do ryzyka i wpływ leku na rozwijający się płód, a także przebieg ciąży i porodu. Podczas wyboru leku należy uwzględnić aktualną sytuację zdrowotną kobiety, farmakokinetykę leku i zdolność przechodzenia przez łożysko oraz toksyczne oddziaływanie na płód. Pomocne mogą być dostępne klasyfikacje i rejestry ciążowe.
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Numer
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Artykuły
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Bibliografia
1. Tinker SC, Broussard CS, Frey MT et al. Prevalence of prescription medication use among non-pregnant women of childbearing age and pregnant women in the United States: NHANES, 1999-2006. Matern Child Health J. 2015; 19(5): 1097-106.
2. Mitchell AA, Gilboa SM, Werler MM et al; National Birth Defects Prevention Study. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol. 2011; 205(1): 51.e1-8.
3. Pregnancy labeling. FDA Drug Bull. 1979; 9(4): 23-4.
4. Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products – Content and Format Guidance for Industry. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) July 2020 Labeling Revision 1.
5. Caritis SN, Venkataramanan R. Obstetrical, fetal, and lactation pharmacology – a crisis that can no longer be ignored. Am J Obstet Gynecol. 2021; 225(1): 10-20.
6. Committee for Medicinal Products for Human Use (CHMP). Guideline on risk assessment of Medicinal Products on Human Reproduction and Lactation: from data to labeling, 24.07.2008.
7. Wollman SC, Alhassoon OM, Hall MG et al. Gray matter abnormalities in opioid-dependent patients: A neuroimaging meta-analysis. Am J Drug Alcohol Abuse. 2017; 43(5): 505-17.
8. Monnelly VJ, Hamilton R, Chappell FM et al. Childhood neurodevelopment after prescription of maintenance methadone for opioid dependency in pregnancy: a systematic review and meta-analysis. Dev Med Child Neurol. 2019; 61(7): 750-60.
9. Soma-Pillay P, Nelson-Piercy C, Tolppanen H et al. Physiological changes in pregnancy. Cardiovasc J Afr. 2016; 27(2): 89-94.
10. Hebert MF, Ma X, Naraharisetti SB et al; Obstetric-Fetal Pharmacology Research Unit Network. Are we optimizing gestational diabetes treatment with glyburide? The pharmacologic basis for better clinical practice. Clin Pharmacol Ther. 2009; 85(6): 607-14.
11. Bastian JR, Chen H, Zhang H et al. Dose-adjusted plasma concentrations of sublingual buprenorphine are lower during than after pregnancy. Am J Obstet Gynecol. 2017; 216(1): 64.e1-64.e7.
12. Pillai VC, Han K, Beigi RH et al. Population pharmacokinetics of oseltamivir in non-pregnant and pregnant women. Br J Clin Pharmacol. 2015; 80(5): 1042-50.
13. Wesley BD, Sewell CA, Chang CY et al. Prescription medications for use in pregnancy – perspective from the US Food and Drug Administration. Am J Obstet Gynecol. 2021; 225(1): 21-32.
2. Mitchell AA, Gilboa SM, Werler MM et al; National Birth Defects Prevention Study. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol. 2011; 205(1): 51.e1-8.
3. Pregnancy labeling. FDA Drug Bull. 1979; 9(4): 23-4.
4. Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products – Content and Format Guidance for Industry. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) July 2020 Labeling Revision 1.
5. Caritis SN, Venkataramanan R. Obstetrical, fetal, and lactation pharmacology – a crisis that can no longer be ignored. Am J Obstet Gynecol. 2021; 225(1): 10-20.
6. Committee for Medicinal Products for Human Use (CHMP). Guideline on risk assessment of Medicinal Products on Human Reproduction and Lactation: from data to labeling, 24.07.2008.
7. Wollman SC, Alhassoon OM, Hall MG et al. Gray matter abnormalities in opioid-dependent patients: A neuroimaging meta-analysis. Am J Drug Alcohol Abuse. 2017; 43(5): 505-17.
8. Monnelly VJ, Hamilton R, Chappell FM et al. Childhood neurodevelopment after prescription of maintenance methadone for opioid dependency in pregnancy: a systematic review and meta-analysis. Dev Med Child Neurol. 2019; 61(7): 750-60.
9. Soma-Pillay P, Nelson-Piercy C, Tolppanen H et al. Physiological changes in pregnancy. Cardiovasc J Afr. 2016; 27(2): 89-94.
10. Hebert MF, Ma X, Naraharisetti SB et al; Obstetric-Fetal Pharmacology Research Unit Network. Are we optimizing gestational diabetes treatment with glyburide? The pharmacologic basis for better clinical practice. Clin Pharmacol Ther. 2009; 85(6): 607-14.
11. Bastian JR, Chen H, Zhang H et al. Dose-adjusted plasma concentrations of sublingual buprenorphine are lower during than after pregnancy. Am J Obstet Gynecol. 2017; 216(1): 64.e1-64.e7.
12. Pillai VC, Han K, Beigi RH et al. Population pharmacokinetics of oseltamivir in non-pregnant and pregnant women. Br J Clin Pharmacol. 2015; 80(5): 1042-50.
13. Wesley BD, Sewell CA, Chang CY et al. Prescription medications for use in pregnancy – perspective from the US Food and Drug Administration. Am J Obstet Gynecol. 2021; 225(1): 21-32.