INACTIVE PHARMACEUTICAL INGREDIENTS: IMPLICATIONS FOR PREGNANCY
Main Article Content
Keywords
INACTIVE PHARMACEUTICAL, PREGNANCY
Abstract
Administration of pharmaceutical agents to pregnant women is a concern, because of safety issues to both mother and fetus. However, all medication formulations contain many other inactive ingredients in addition to the active drug. In contrast to the extensive research on the safety of active pharmaceutical ingredients in pregnant patients, the fetal safety of the inactive ingredients has been largely ignored. This is likely due to the fact that the inactive ingredients are considered to be in “small amounts” and are believed to be “inert”. However, this is often not the case. Most pharmaceutical preparations will typically contain 5 to 10 times more inactive ingredients in terms of weight versus the actual active ingredients. Therefore, most tablets, for example, are mainly made up of inactive ingredients.
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8. Shin YK, Collea JV, Kim YD. The effect of glucagon on spontaneous contractility of isolated pregnant uterine muscle. Obstet Gynecol 1996; 88(5):867 -871.
9. Schini SA, Bavister BD. Two -cell block to development of cultured hamster embryos is caused by phosphate and gl ucose. Biol Reprod 1988; 39(5):1183 -1192.
10. Seshagiri PB, Bavister BD. Glucose inhibits development of hamster 8 -cell embryos in vitro. Biol Reprod 1989; 40(3):599 -606.
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14. Gale TF. Effects of in vivo exposure of pregnant hamsters to glucose. 1. Abnormalities in LVG strain fetuses following intermittent multiple treatments with two isomers. Teratology 1991; 44(2):193 -202.
15. Phili pson EH, Kalhan SC, Riha MM, Pimentel R. Effects of maternal glucose infusion on fetal acid -base status in human pregnancy. Am J Obstet Gynecol 1987; 157(4 Pt 1):866 -873.
16. Singhi S, Chookang E, Hall JS, Kalghatgi S. Iatrogenic neonatal and maternal hyponatr aemia following oxytocin and aqueous glucose infusion during labour. Br J Obstet Gynaecol 1985; 92(4):356 -363.
17. McIntyre HD, Russell A, Serek R, Veveris -Lowe T, Cotterill A, Cowley D et al. Placental growth hormone is not suppressed by oral glucose loading in normal human pregnancy. Horm Metab Res 2002; 34(5):250 -253.
18. Patterson EC, Staszak DJ. Effects of geophagia (kaolin ingestion) on the maternal blood and embryonic development in the pregnant rat. J Nutr 1977; 107(11):2020 -2025.
19. Elmore AR. Final report on the safety assessment of aluminum silicate, calcium silicate, magnesium aluminum silicate, magnesium silicate, magnesium trisilicate, sodium magnesium silicate, zirconium silicate, attapulgite, bentonite, Fuller's earth, hectorite, kaolin, lithium magnesi um silicate, lithium magnesium sodium silicate, montmorillonite, pyrophyllite, and zeolite. Int J Toxicol 2003; 22 Suppl 1:37 -102.
20. Black RA, Hill DA. Over -the -counter medications in pregnancy. Am Fam Physician 2003; 67(12):2517 -2524.
21. Lione A. Aluminum toxi cology and the aluminum -containing medications. Pharmacol Ther 1985; 29(2):255 -285.
22. Berkowitz RL. Handbook for prescribing medications during pregnancy. Boston: 1981.
23. Anane R, Bonini M, Creppy EE. Transplacental passage of aluminum from pregnant mice to fe tus organs after maternal transcutaneous exposure. Hum Exp Toxicol 1997; 16(9):501 - 504.
24. Benett RW, Persaud TV, Moore KL. Experimental studies on the effects of aluminum on pregnancy and fetal development. Anat Anz 1975; 138(5):365 -378.
25. Hall GS, Carr MJ, Cu mmings E, Lee M. Aluminum, barium, silicon, and strontium in amniotic fluid by emission spectrometry. Clin Chem 1983; 29(6):1318.
26. McCormack KM, Ottosen LD, Sanger VL, Sprague S, Mayor GH, Hook JB. Effect of prenatal administration of aluminum and parathyro id hormone on fetal development in the rat. Proc Soc Exp Biol Med 1979; 161(1):74 -77.
27. Paternain JL, Domingo JL, Llobet JM, Corbella J. Embryotoxic and teratogenic effects of aluminum nitrate in rats upon oral administration. Teratology 1988; 38(3):253 -257.
28. Wide M. Effect of short -term exposure to five industrial metals on the embryonic and fetal development of the mouse. Environ Res 1984; 33(1):47 -53.
29. Bernuzzi V, Desor D, Lehr PR. Developmental alternations in offspring of female rats orally intoxicated by aluminum chloride or lactate during gestation. Teratology 1989; 40(1):21 -27.
30. Yokel RA. Toxicity of gestational aluminum exposure to the maternal rabbit and offspring. Toxicol Appl Pharmacol 1985; 79(1):121 -133.
31. Golub MS, Gershwin ME, Donald JM, Negri S, Ke en CL. Maternal and developmental toxicity of chronic aluminum exposure in mice. Fundam Appl Toxicol 1987; 8(3):346 -357.
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