Monitoring post-approval drug safety in pregnancy: pharmacogenetic aspects
Abstract
The purpose of this article is to describe and to examine the utility of new pharmacogenetic approaches in monitoring post-approval drug safety in pregnancy. Data on gene expression in pregnancy and metabolic variation may, in specific instances, help to predict adverse drug reactions in the mother-placenta-fetus complex and to identify individuals at a higher risk.
About the Author
Елена Сокова
Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации
Russian Federation
Russian Federation
References
1. Advances in FDA’s Safety Program for Marketed Drugs. Drug Safety Report April 2012. Center for Drug Evaluation and Research U.S. Food and Drug Administration U.S. Health and Human Services A.
2. Atkinson D, Brice-Bennet S, D’souza SW. Antiepileptic medication during pregn ancy: does fetal genotype affect outcome? Pediatric research 2007; 62(2): 120-127.
3. Briggs GG, Freeman RK, Yaffe SJ. A reference guide to fetal and neon atal risk. Drugs in pregn ancy and lactation. Li ppincott Williams&Wilkins 2011; (9).
4. Ceckova-Novatn a M, Pavec P, Staud F. P-glycoprotein in the placenta: Expression, localization, regulation and function. Reproductive Toxicology 2006; 22(3): 400-410.
5. Fromm MF. Importance of P-glycoprotein at blood–tissue barriers. Trends Pharmacol Sci 2004; 25(8): 423-9.
6. EMEA. Guideline on the exposure to medicin al products during pregn ancy: need for post-authorisation. CHMP Rep; 2005; 313666.
7. Isoherranen N, Kenneth E. Drug metabolism and transport during pregn ancy: how does drug disposition change during pregn ancy and what are the mechanisms that cause such changes? Drug Metab Dispos 2013; 41: 256-262.
8. Landau R. Pharmacogenetics and obstetric anesthesia. Anesthesiol Clin 2008; 26 (1):183-95.
9. Mattison DR. Clinical Pharmacology during pregn ancy. ELSEVIER 2013; 471.
10. Sim SC, Ingelman-Sundberg V. Pharmacogenomic biomarkers: new tools in current and future drug therapy. Trends Pharmacol Sci 2011; 32: 72-81.
11. Merkulov VА, Bunyatyan ND, Sakaeva IV, Lepakhin VK, Romanov BK, Efremova TА. Novye zakonodatel'nye initsiativy po povysheniyu bezopasnosti lekarstvennykh sredstv v evropejskom soyuze. Vedomosti Nauchnogo tsentra ehkspertizy sredstv meditsinskogo primeneniya. 2013. № 3. S. 45-48.
12. Kutekhova GV, Lepakhin VK, Romanov BK. Vyyavlenie n azn acheniya lekarstvennykh sredstv s n arusheniyami predpisanij instruktsii (OFF-LABEL) v pediatricheskoj praktike. Vedomosti Nauchnogo tsentra ehkspertizy sredstv meditsinskogo primeneniya. 2012. № 3. S. 23-27.
13. Sheffer K, Shpilman KH, Fetter K. Drug therapy during pregn ancy and lactation. Moscow: Logosfera; 2010 (in Russian).
14. Lepakhin VK, Romanov BK, Toropova IА. Аn aliz soobshhenij o nezhelatel'nykh reaktsiyakh n a lekarstvennye sredstva. Vedomosti Nauchnogo tsentra ehkspertizy sredstv meditsinskogo primeneniya. 2012. № 1. S. 22-25.
15. Аlyautdin RN, Zatsepilova TА, Romanov BK. Аntiangin al'nye lekarstvennye sredstva. Rossijskij meditsinskij zhurn al. 2007. № 4. S. 35-40.
16. Reviewer guidance evaluating the risk of drug exposure in human pregn ancies. U. S. Department of health and human services, food and drug administrtion, center for drug evaluation and research (CDER). Center for Biologics Evaluation and Research (CBER) 2005; 28.
17. Lepakhin VK, Romanov BK, Nikitin a TN, Snegireva II. Expertise assess the relationshi p between the expected benefit and possible risk from the use of medicines. Scientific centre for expert evaluation of medical products bulletin. 2012; 2: 19-21.
18. Ryon MG, Sawhney DS. Scientific ration ale for the selection of toxicity testing methods II. Teratology, immunotoxicology, and inhalation toxicology. United States Environmental Protection Agency 1985; 253.
19. Lo WY, Friedman JM. Teratogenicity of recently introduced medications in human pregn ancy. Obstet Gynecol 2002; 100 (3): 465–73.
20. Romanov BK. Calcium regulation of activity of lysosomal enzymes of the myocardium // Biomedical chemistry 2005; 51 (6): 634-642.
21. Sher SA. Teratogenic effects of drugs on the body of the unborn child at the stage of fetal development. Pediatric pharmacology 2011; 8 (6): 57–60.
Review
For citations:
Monitoring post-approval drug safety in pregnancy: pharmacogenetic aspects. Safety and Risk of Pharmacotherapy. 2015;(3):30-35. (In Russ.)
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