Du er her: IRF Lægemiddelspørgsmål Rygeafvænning under graviditet – hvad er bedst?


Rygeafvænning under graviditet – hvad er bedst?

Bemærk at indholdet på denne side er mere end ét år gammel. Indholdet afspejler derfor ikke nødvendigvis IRFs nuværende holdning.


Rygeafvænningsprogrammer reducerer forekomsten af rygning under graviditeten og risikoen for lav fødselsvægt samt tidlig fødsel. Dokumentation peger i retning af, at belønning eller individuel, mundtlig vejledning af uddannet personale, fulgt op af skriftligt materiale, har effekt.




Effekten af nikotinsubstitution hos gravide rygere er ikke tilstrækkeligt undersøgt til generelt at anbefale anvendelse. Om end nikotinsubstitution under graviditeten ikke er risikofrit, synes risikoen ikke at være væsentlig øget, og formentlig mindre end ved rygning. Nikotinsubstitutionsbehandling med tyggegummi eller plaster kan derfor overvejes for nogle gravide, når anden rådgivning er mislykket.




Med baggrund i de begrænsede data på tolerabilitet og effekt hos gravide kan vi ikke anbefale at anvende bupropion (Zyban) under graviditeten.


Does bupropion treatment during pregnancy pose a risk to the fetus?

- How should smoking cessation during pregnancy be approached?



Smoking cessation programs reduce the proportion of women who continue to smoke during pregnancy, and reduce low birthweight and preterm birth. Evidence points in the direction, that interventions including rewards or individual, oral counselling by educated personel, followed up by written information have an effect on smoking cessation among pregnant women.




The efficacy of nicotine substitution in pregnant smokers has not been adequately studied to recommend their general use. Although nicotine substitution during pregnancy is not completely without risks, the risk appears not to be substantially increased, and is probably less than smoking. Nicotine substitution with gum or patches may be considered with certain pregnant patients, when counselling has failed.




Due to the limited safety and efficacy experience during pregnancy, we cannot recommend the use of bupropion during pregnancy.


Case description

A woman smoking 40 cigarettes daily is pregnant in the 20th week of gestation. Her GP requests an assessment of the risk of using bupropion during pregnancy.


Background information

The Drug Information Center has recently dealt with the issue of bupropion use during pregnancy in Fynske Laeger (1), and it was concluded, primarily from the manufacturers pregnancy register´s data on first trimester exposure, that a small increased risk of congential malformations can not be excluded. The manufacturers register also included some data on second and third trimester exposure. Of the 57 pregnancy outcomes with the earliest bupropion exposure in the second trimester there were 56 live births without birth defects and one spontaneous pregnancy loss without a birth defect. Of the 22 pregnancy outcomes with the earliest exposure in the third trimester there were 21 live births without birth defects and one fetal death without birth defects (2). Reviews of smoking cessation during pregnancy, in general, recommend that bupropion should be avoided during pregnancy or should be second line pharmacologic aid, given that no controlled studies of smoking cessation in pregnant women have examined the safety and efficacy of bupropion. Moreover, a small seizure risk exists with this medication (3,4,5).




The literature on behavioral intervention for smoking cessation during pregnancy is enormous. A Cochrane meta-analysis of 64 randomised and quasi-randomised trials of smoking cessation programs implemented during pregnancy concluded that smoking cessation programs in pregnancy reduce the proportion of women who continue to smoke, and reduce low birthweight and preterm birth. Interventions commonly included in these programs were: the provision of information on the risks of smoking to the fetus and infant and the benefits of quitting; recommendations to quit and setting a quit date; feedback about the fetus; feedback about harmful levels of cotinine or carbon monoxide; teaching cognitive-behavioural strategies for quitting smoking; advice tailored to "stages of change"; provision of rewards, social or peer support; and nicotine replacement therapy. There was substantial variation in the intensity of the intervention and the extent of reminders and reinforcement through pregnancy. One intervention strategy, rewards plus social support (two trials), resulted in a significantly greater smoking reduction than other strategies (RR 0.77, 95% CI 0.72 to 0.82) (6).




A Danish systematic review at the National Board of Health`s webside concludes that studies points in the direction that individual, oral counselling by educated personel, followed up by written information has an effect on smoking cessation among pregnant women. The effect appears though to be dependent of national and socioeconomic conditions (7). Among studies performed in Denmark, effect has been shown by intensive counselling by specialised midwife, while general written information and counselling within the ordinary setting of pregnancy consultations did not show an effect (8).




Clinical data on the efficacy of nicotine substitution therapy during pregnancy is too scarce, as well as debatable, to recommend general use in pregnant smokers. Clinical data are only available for gum and patch (4). The available, although limited, data suggests that nicotine replacement therapy is safe during pregnancy (3,4). Nicotine has been shown to be toxic to developing fetus in animal studies (3). Several studies have examined nicotine levels with nicotine patch administration and gum and found that nicotine levels were similar or lower to those produced by smoking in pregnant smokers (3,4,10) and it seems reasonable to suggest that exposure to nicotine is less harmful than exposure to smoking which includes nicotine, cabonmonoxide and a lot of other toxins. It is the opinion of some expert panels that nicotine substitution during pregnancy problably outweighs the risk of smoking (4). The National Board of Health states that nicotine patches and gum, principally, should not be recommended to pregnant women. However, if cessation fails, it is recommended that the patient consults her GP about the use of nicotine substitution (11).




Various guidelines suggest that nicotine substitution may be appropiate with certain pregnant patients (3,4,5,12), but should only be considered when counselling has failed and the risks of smoking outweigh the potential risks of pharmacotherapy and concurrent continued smoking. Some recommendations prefers the use of intermittent delivery (gum, inhaler, nasal) because these would be expected to give a smaller daily dose that continous delivery system such as the patch. Heavy smokers may need a more constant release of nicotine to relieve withdrawal symptoms and for those the patch may be preferred. This may also be appropiate for patients with nausea and vomiting. Sixteen hours rather than 24 hours use of the patch is recommended to minimize total daily exposure to the fetus (3,4).



  1. Larsen J. Hedegaard U. Bupropion (Zyban) – bivirkninger, interaktioner og anvendelse under graviditet. Fynske Læger 2003(6):30.
  2. The Bupropion Pregnancy Registry - interim report. 1. Septeber through 28. February 2003. Issued: June 2003. GlaxoSmithKline.
  3. Benowitz N, Dempsey D. Pharmacotherapy for smoking cessation during pregnancy. Nicotine Tob Res. 2004 Apr;6 Suppl 2:S189-202. Review.
  4. Oncken CA, Kranzler HR. Pharmacotherapies to enhance smoking cessation during pregnancy. Drug Alcohol Rev. 2003 Jun;22(2):191-202. Review.
  5. Ashmead GG. Smoking and pregnancy. J Matern Fetal Neonatal Med. 2003 Nov;14(5):297-304. Review.
  6. Lumley J, Oliver SS, Chamberlain C, Oakley L.Interventions for promoting smoking cessation during pregnancy.Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001055. Review.
  7. Wisborg K, Henriksen TB. Tobak og graviditet. Er der behov for forebyggelse? Er der effektive metoder?. Sundhedsstyrelsen. (cited 05/02/16).http://www.sundhedsstyrelsen.dk/.
  8. Wisborg K, Henriksen TB. Graviditet og tobak. En statusartikel med fokus på danske forhold. Ugeskr Laeger. 2003 Nov 17;165(47):4537-40.
  9. The Drug Information Center, Odense, Denmark. Case no 1189 (2003).
  10. Oncken CA, Hatsukami DK, Lupo VR, Lando HA, Gibeau LM, Hansen RJ. Effects of short-term use of nicotine gum in pregnant smokers.
  11. Clin Pharmacol Ther. 1996 Jun;59(6):654-61www.sundhedsstyrelsen.dk.
  12. Sundhedsstyrelsen. Graviditet og rygning (cited 05/02/16). http://www.sundhedsstyrelsen.dk/.
  13. Albrecht SA, Maloni JA, Thomas KK, Jones R, Halleran J, Osborne J. Smoking cessation counseling for pregnant women who smoke: scientific basis for practice for AWHONN's SUCCESS project. J Obstet Gynecol Neonatal Nurs. 2004 May-Jun;33(3):298-305.

References Consulted

  • Laegemiddelinformationscentralen, CeKFO, Odense, Denmark.  
  • Cochrane Library.  
  • Medline.  
  • Micromedex.  
  • RELIS database: http:/www.relis.no/database.  
  • Läkemedel & Fosterskador:www.janusinfo.se.

Institut for Rationel Farmakoterapi, 13. maj 2005






Læs Rationel Farmakoterapi nr. 3 2005 om medicin til gravide og ammende


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