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December 11, 1991, Vol 266, No. 22 >
ARTICLE | December 11, 1991

Nicotine Replacement Therapy During Pregnancy FREE

Neal L. Benowitz, MD
[+] Author Affiliations

This report was submitted to the Food and Drug Administration Drugs of Abuse Advisory Committee, May 8, 1991. The opinions expressed are those of the author and do not necessarily reflect those of the Food and Drug Administration.

Reprint requests to the Division of Clinical Pharmacology and Experimental Therapeutics, San Francisco General Hospital Medical Center, 1011 Potrero Ave, Bldg 30, 5th Floor, San Francisco, CA 94110 (Dr Benowitz).


JAMA. 1991;266(22):3174-3177. doi:10.1001/jama.1991.03470220090034
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References

CIGARETTE smoking is a major preventable cause of fetal death and injury, yet many women continue to smoke cigarettes throughout pregnancy. The most effective pharmacologic adjunct to smoking cessation therapy is nicotine replacement, including nicotine chewing gum or transdermal nicotine. However, the use of nicotine replacement therapy is contraindicated during pregnancy. The analysis presented herein suggests that the benefits of nicotine replacement therapy to aid smoking cessation in pregnant women who cannot stop smoking without such therapy substantially outweigh the risks of continued smoking or the risks of nicotine replacement per se.

PREVALENCE OF CIGARETTE SMOKING DURING PREGNANCY  Although the prevalence of smoking has declined in recent years and many women quit smoking when they become pregnant, 20% to 25% of pregnant American women continue to smoke throughout pregnancy; many of these women are heavy smokers. The National Health Interview survey of women pregnant in 1985 or with a birth

REFERENCES

1 +
Fingerhut LA, Kleinman JC, Kendrick JS.  Smoking before, during, and after pregnancy. Am J Public Health . 1990;;80:541-544.
2 +
Williamson DF, Serdula MK, Kendrick JS, Binkin NJ.  Comparing the prevalence of smoking in pregnant and nonpregnant women, 1985 to 1986. JAMA . 1989;;261:70-74.
3 +
Stockbauer JW, Land GH.  Changes in characteristics of women who smoke during pregnancy: Missouri, 1978-88. Public Health Rep . 1991;;106:52-58.
4 +
Centers for Disease Control.  Cigarette smoking among reproductive-aged women—Idaho and New York. MMWR . 1990;;39:659-662.
5 +
Centers for Disease Control.  Effects of maternal cigarette smoking on birth weight and preterm birth—Ohio, 1989. MMWR . 1990;;39:662-665.
6 +
Davis RL, Tollestrup K, Milham S Jr.  Trends in teenage smoking during pregnancy: Washington State, 1984 through 1988. AJDC . 1990;;144:1297-1301.
7 +
Sexton M, Hebel JR.  A clinical trial of change in maternal smoking and its effect on birth weight. JAMA . 1984;;251:911-915.
8 +
Surgeon General. The Health Consequences of Smoking for Women: A Report of the Surgeon General, 1983 . Washington, DC: US Government Printing Office; 1983;:191-249. US Dept of Health and Human Services publication 410-889/1284.
9 +
Stillman RJ, Rosenberg MJ, Sachs BP.  Smoking and reproduction. Fertil Steril . 1986;;46:545-566.
10 +
Centers for Disease Control. The Health Benefits of Smoking Cessation: A Report of the Surgeon General, 1990 . Rockville, Md: Public Health Service, Office on Smoking and Health; 1990;. US Dept of Health and Human Services publication No. CDC 90-8416.
11 +
Garn SM, Johnston M, Ridella SA, Petzold AS.  Effect of maternal cigarette smoking on Apgar scores. AJDC . 1981;;135:503-506.
12 +
Naeye RL, Peters EC.  Mental development of children whose mothers smoked during pregnancy. Obstet Gynecol . 1984;;64:601-607.
13 +
Fried PA, Watkinson B.  36- and 48-month neurobehavioral follow-up of children prenatally exposed to marijuana, cigarettes, and alcohol. J Dev Behav Pediatr . 1990;;11:49-58.
14 +
Nieburg P, Marks JS, McLaren NM, Remington PL.  The fetal tobacco syndrome. JAMA . 1985;;253:2998-2999.
15 +
MacArthur C, Newton JR, Knox EG.  Effect of antismoking health education on fetal size: a randomized clinical trial. Br J Obstet Gynaecol . 1987;;94:293-300.
16 +
Ershoff DH, Quinn VP, Mullen PD, Lairson DR.  Pregnancy and medical cost outcomes of a self-help prenatal smoking cessation program in a HMO. Public Health Rep . 1990;;105:340-347.
17 +
Benowitz NL.  Pharmacologic aspects of cigarette smoking and nicotine addiction. N Engl J Med . 1988;;319:1318-1330.
18 +
Lam W, Sze PC, Sacks HS, Chalmers TC.  Meta-analysis of randomised controlled trials of nicotine chewing-gum. Lancet . 1987;;2:27-30.
19 +
Tonnesen P, Fryd V, Hansen M, et al.  Effect of nicotine chewing gum in combination with group counseling on the cessation of smoking. N Engl J Med . 1988;;318:15-18.
20 +
Hurt RD, Lauger GG, Offord KP, Kottke TE, Dale LC.  Nicotine-replacement therapy with use of a transdermal nicotine patch: a randomized double-blind placebo-controlled trial. Mayo Clin Proc . 1990;;65:1529-1537.
21 +
Tønnesen P, Nørregaard J, Simonsen K, Säwe U.  A double-blind trial of 16-hour transdermal nicotine patch in smoking cessation. N Engl J Med . 1991;;325:311-315.
22 +
Hickner J, Cousineau A, Messimer S.  Smoking cessation during pregnancy: strategies used by Michigan family physicians. J Am Board Fam Pract . 1990;;3:39-42.
23 +
Longo LD.  Carbon monoxide: effects on oxygenation of the fetus in utero. Science . 1976;;194:523-525.
24 +
Longo LD.  The biological effects of carbon monoxide on the pregnant woman, fetus, and newborn infant. Am J Obstet Gynecol . 1977;;129:69-103.
25 +
Bureau MA, Monette J, Shapcott D, et al.  Carboxyhemoglobin concentration in fetal cord blood and in blood of mothers who smoked during labor. Pediatrics . 1982;;69:371-373.
26 +
Resnik R, Brink GW, Wilkes M.  Catecholamine-mediated reduction in uterine blood flow after nicotine infusion in the pregnant ewe. J Clin Invest . 1979;;63:1133-1136.
27 +
Lehtovirta P, Forss M.  The acute effect of smoking on intervillous blood flow of the placenta. Br J Obstet Gynaecol . 1978;;85:729-731.
28 +
Philipp K, Pateisky N, Endler M.  Effects of smoking on uteroplacental blood flow. Gynecol Obstet Invest . 1984;;17:179-182.
29 +
Lehtovirta P, Forss M, Rauramo I, Kariniemi V.  Acute effects of nicotine on fetal heart rate variability. Br J Obstet Gynaecol . 1983;;90:710-715.
30 +
Manning FA, Feyerabend C.  Cigarette smoking and fetal breathing movements. Br J Obstet Gynaecol . 1976;;83:262-270.
31 +
Divers WA Jr, Wilkes MM, Babaknia A, Yen SSC.  Maternal smoking and elevation of catecholamines and metabolites in the amniotic fluid. Am J Obstet Gynecol . 1981;;141:625-628.
32 +
Ahlsten G, Ewald U, Tuvemo T.  Prostacyclinlike activity in umbilical arteries is dose-dependently reduced by maternal smoking and related to nicotine levels. Biol Neonate . 1990;;58:271-278.
33 +
Peters DAV, Taub H, Tang S.  Postnatal effects of maternal nicotine exposure. Neurobehav Toxicol . 1979;;1:221-225.
34 +
Navarro HA, Seidler FJ, Whitmore WL, Slotkin TA.  Prenatal exposure to nicotine via maternal infusions: effects on development of catecholamine systems. J Pharmacol Exp Ther . 1988;;244:940-944.
35 +
Navarro HA, Seidler FJ, Eylers JP, et al.  Effects of prenatal nicotine exposure on development of cental and peripheral cholinergic neurotransmitter systems: evidence of cholinergic trophic influences in developing brain. J Pharmacol Exp Ther . 1989;;251:894-900.
36 +
Benowitz NL, Jacob P III, Savanapridi C.  Determinants of nicotine intake while chewing nicotine polacrilex gum. Clin Pharmacol Ther . 1987;;41:467-473.
37 +
Benowitz NL, Chan K, Denaro CP, Jacob P III.  Stable isotope methodology for studying transdermal drug absorption: the nicotine patch. Clin Pharmacol Ther . 1991;;50:286-293.
38 +
Benowitz NL, Kuyt F, Jacob P III.  Influence of nicotine on cardiovascular and hormonal effects of cigarette smoking. Clin Pharmacol Ther . 1984;;36:74-81.
39 +
Benowitz NL.  Increased 24-hour energy expenditure in cigarette smokers. N Engl J Med . 1986;;315:1639-1640.
40 +
Benowitz NL, Porchet H, Sheiner L, Jacob P III.  Nicotine absorption and cardiovascular effects with smokeless tobacco use: comparison with cigarettes and nicotine gum. Clin Pharmacol Ther . 1988;;44:23-28.
41 +
Benowitz NL.  Toxicity of nicotine: implications with regard to nicotine replacement therapy.  In: Pomerleau OF, Pomerleau CS, eds. Nicotine Replacement: A Critical Evaluation . New York, NY: Alan R Liss Inc; 1988;:187-217.
42 +
Benowitz NL, Jacob P III.  Intravenous nicotine replacement suppresses nicotine intake from cigarette smoking. J Pharmacol Exp Ther . 1990;;254:1000-1005.

Figures

Tables

Interactive Graphics

Video

Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Fingerhut LA, Kleinman JC, Kendrick JS.  Smoking before, during, and after pregnancy. Am J Public Health . 1990;;80:541-544.
2 +
Williamson DF, Serdula MK, Kendrick JS, Binkin NJ.  Comparing the prevalence of smoking in pregnant and nonpregnant women, 1985 to 1986. JAMA . 1989;;261:70-74.
3 +
Stockbauer JW, Land GH.  Changes in characteristics of women who smoke during pregnancy: Missouri, 1978-88. Public Health Rep . 1991;;106:52-58.
4 +
Centers for Disease Control.  Cigarette smoking among reproductive-aged women—Idaho and New York. MMWR . 1990;;39:659-662.
5 +
Centers for Disease Control.  Effects of maternal cigarette smoking on birth weight and preterm birth—Ohio, 1989. MMWR . 1990;;39:662-665.
6 +
Davis RL, Tollestrup K, Milham S Jr.  Trends in teenage smoking during pregnancy: Washington State, 1984 through 1988. AJDC . 1990;;144:1297-1301.
7 +
Sexton M, Hebel JR.  A clinical trial of change in maternal smoking and its effect on birth weight. JAMA . 1984;;251:911-915.
8 +
Surgeon General. The Health Consequences of Smoking for Women: A Report of the Surgeon General, 1983 . Washington, DC: US Government Printing Office; 1983;:191-249. US Dept of Health and Human Services publication 410-889/1284.
9 +
Stillman RJ, Rosenberg MJ, Sachs BP.  Smoking and reproduction. Fertil Steril . 1986;;46:545-566.
10 +
Centers for Disease Control. The Health Benefits of Smoking Cessation: A Report of the Surgeon General, 1990 . Rockville, Md: Public Health Service, Office on Smoking and Health; 1990;. US Dept of Health and Human Services publication No. CDC 90-8416.
11 +
Garn SM, Johnston M, Ridella SA, Petzold AS.  Effect of maternal cigarette smoking on Apgar scores. AJDC . 1981;;135:503-506.
12 +
Naeye RL, Peters EC.  Mental development of children whose mothers smoked during pregnancy. Obstet Gynecol . 1984;;64:601-607.
13 +
Fried PA, Watkinson B.  36- and 48-month neurobehavioral follow-up of children prenatally exposed to marijuana, cigarettes, and alcohol. J Dev Behav Pediatr . 1990;;11:49-58.
14 +
Nieburg P, Marks JS, McLaren NM, Remington PL.  The fetal tobacco syndrome. JAMA . 1985;;253:2998-2999.
15 +
MacArthur C, Newton JR, Knox EG.  Effect of antismoking health education on fetal size: a randomized clinical trial. Br J Obstet Gynaecol . 1987;;94:293-300.
16 +
Ershoff DH, Quinn VP, Mullen PD, Lairson DR.  Pregnancy and medical cost outcomes of a self-help prenatal smoking cessation program in a HMO. Public Health Rep . 1990;;105:340-347.
17 +
Benowitz NL.  Pharmacologic aspects of cigarette smoking and nicotine addiction. N Engl J Med . 1988;;319:1318-1330.
18 +
Lam W, Sze PC, Sacks HS, Chalmers TC.  Meta-analysis of randomised controlled trials of nicotine chewing-gum. Lancet . 1987;;2:27-30.
19 +
Tonnesen P, Fryd V, Hansen M, et al.  Effect of nicotine chewing gum in combination with group counseling on the cessation of smoking. N Engl J Med . 1988;;318:15-18.
20 +
Hurt RD, Lauger GG, Offord KP, Kottke TE, Dale LC.  Nicotine-replacement therapy with use of a transdermal nicotine patch: a randomized double-blind placebo-controlled trial. Mayo Clin Proc . 1990;;65:1529-1537.
21 +
Tønnesen P, Nørregaard J, Simonsen K, Säwe U.  A double-blind trial of 16-hour transdermal nicotine patch in smoking cessation. N Engl J Med . 1991;;325:311-315.
22 +
Hickner J, Cousineau A, Messimer S.  Smoking cessation during pregnancy: strategies used by Michigan family physicians. J Am Board Fam Pract . 1990;;3:39-42.
23 +
Longo LD.  Carbon monoxide: effects on oxygenation of the fetus in utero. Science . 1976;;194:523-525.
24 +
Longo LD.  The biological effects of carbon monoxide on the pregnant woman, fetus, and newborn infant. Am J Obstet Gynecol . 1977;;129:69-103.
25 +
Bureau MA, Monette J, Shapcott D, et al.  Carboxyhemoglobin concentration in fetal cord blood and in blood of mothers who smoked during labor. Pediatrics . 1982;;69:371-373.
26 +
Resnik R, Brink GW, Wilkes M.  Catecholamine-mediated reduction in uterine blood flow after nicotine infusion in the pregnant ewe. J Clin Invest . 1979;;63:1133-1136.
27 +
Lehtovirta P, Forss M.  The acute effect of smoking on intervillous blood flow of the placenta. Br J Obstet Gynaecol . 1978;;85:729-731.
28 +
Philipp K, Pateisky N, Endler M.  Effects of smoking on uteroplacental blood flow. Gynecol Obstet Invest . 1984;;17:179-182.
29 +
Lehtovirta P, Forss M, Rauramo I, Kariniemi V.  Acute effects of nicotine on fetal heart rate variability. Br J Obstet Gynaecol . 1983;;90:710-715.
30 +
Manning FA, Feyerabend C.  Cigarette smoking and fetal breathing movements. Br J Obstet Gynaecol . 1976;;83:262-270.
31 +
Divers WA Jr, Wilkes MM, Babaknia A, Yen SSC.  Maternal smoking and elevation of catecholamines and metabolites in the amniotic fluid. Am J Obstet Gynecol . 1981;;141:625-628.
32 +
Ahlsten G, Ewald U, Tuvemo T.  Prostacyclinlike activity in umbilical arteries is dose-dependently reduced by maternal smoking and related to nicotine levels. Biol Neonate . 1990;;58:271-278.
33 +
Peters DAV, Taub H, Tang S.  Postnatal effects of maternal nicotine exposure. Neurobehav Toxicol . 1979;;1:221-225.
34 +
Navarro HA, Seidler FJ, Whitmore WL, Slotkin TA.  Prenatal exposure to nicotine via maternal infusions: effects on development of catecholamine systems. J Pharmacol Exp Ther . 1988;;244:940-944.
35 +
Navarro HA, Seidler FJ, Eylers JP, et al.  Effects of prenatal nicotine exposure on development of cental and peripheral cholinergic neurotransmitter systems: evidence of cholinergic trophic influences in developing brain. J Pharmacol Exp Ther . 1989;;251:894-900.
36 +
Benowitz NL, Jacob P III, Savanapridi C.  Determinants of nicotine intake while chewing nicotine polacrilex gum. Clin Pharmacol Ther . 1987;;41:467-473.
37 +
Benowitz NL, Chan K, Denaro CP, Jacob P III.  Stable isotope methodology for studying transdermal drug absorption: the nicotine patch. Clin Pharmacol Ther . 1991;;50:286-293.
38 +
Benowitz NL, Kuyt F, Jacob P III.  Influence of nicotine on cardiovascular and hormonal effects of cigarette smoking. Clin Pharmacol Ther . 1984;;36:74-81.
39 +
Benowitz NL.  Increased 24-hour energy expenditure in cigarette smokers. N Engl J Med . 1986;;315:1639-1640.
40 +
Benowitz NL, Porchet H, Sheiner L, Jacob P III.  Nicotine absorption and cardiovascular effects with smokeless tobacco use: comparison with cigarettes and nicotine gum. Clin Pharmacol Ther . 1988;;44:23-28.
41 +
Benowitz NL.  Toxicity of nicotine: implications with regard to nicotine replacement therapy.  In: Pomerleau OF, Pomerleau CS, eds. Nicotine Replacement: A Critical Evaluation . New York, NY: Alan R Liss Inc; 1988;:187-217.
42 +
Benowitz NL, Jacob P III.  Intravenous nicotine replacement suppresses nicotine intake from cigarette smoking. J Pharmacol Exp Ther . 1990;;254:1000-1005.

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