Abstract
Background
Many studies have described the prescribing of drugs to pregnant women, but only very few have data concerning the periconceptional period specifically.
Aim
The aim of the study was to evaluate the incidence of exposure to teratogenic drugs during early pregnancy and to determine whether a safer drug exists.
Methods
In a French health insurances database, we analyzed drugs prescribed during the period starting 1 month before and ending 2 months after the beginning of pregnancy between 1 January 2006 and 31 December 2007. Based on the Summary of Product Characteristics (SPC), drugs we considered were those ‘contraindicated’, ‘not recommended’, ‘to be avoided’, and ‘possible’ for use during the first trimester of pregnancy. For drugs ‘contraindicated’, we established if there were alternatives with similar efficacy for the mother and lower risk for the fetus.
Results
Over a period of 2.25 years, 8754 drugs were prescribed to 1793 women starting 1 month prior to and ending 2 months after conception. Among these drugs, 20 (0.2%) were ‘contraindicated’, 195 (2.2%) were ‘not recommended’, and 1209 (13.8%) were ‘to be avoided’ during the first trimester of pregnancy. Twenty (1.1%) women received at least one drug that was ‘contraindicated’ during the first trimester, 171 (9.5%) received a drug that was ‘not recommended’ and 768 (42.8%) received a drug that was ‘to be avoided’. At least one possible alternative was available for all except one ‘contraindicated’ drug.
Conclusions
During the highest teratogenic risk period, 1.1% of women received a contraindicated drug, despite existence of a safer alternative drug. This may be partly accounted for by physicians not being aware of the pregnancy at the time the drug was administered and could be reduced by adding a section entitled ‘women of child-bearing potential’ to the SPC.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Beyens MN, Guy C, Ratrema M, et al. Prescription of drugs to pregnant women in France: the HIMAGE study. Therapie 2003; 58: 505–11
Lacroix I, Damase-Michel C, Lapeyre-Mestre M, et al. Prescription of drugs during pregnancy in France. Lancet 2000; 356: 1735–6
Felix RJ, Lyons Jones K, Johnson KA, et al., for the Organization of Teratology Information Servcies (OTIS) Collaborative Research Group. Postmarketing surveillance for drug safety in pregnancy: the organization of teratology information services project. Birth Defects Res 2004; 70 (Part A): 944–7
Koren G, Pastuszak A, Ito S. Dugs in pregnancy. N Engl J Med 1998; 338: 1128–37
Cleary BJ, Butt H, Strawbridge JD, et al. Medication use in early pregnancy-prevalence and determinants of use in a prospective cohort of women. Pharmacoepidemiol Drug Saf 2010; 19: 408–17
Gagne JJ, Maio V, Berghella V, et al. Prescription drug use during pregnancy: a population-based study in Regione Emilia-Romagna, Italy. Eur J Clin Pharmacol 2008; 64: 1125–32
Malm H, Martikainen J, Klaukka T, et al. Prescription of hazardous drugs during pregnancy. Drug Saf 2004; 27: 899–908
Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in pregnancy. Am J Obst Gynecol 2004; 191: 398–407
Bakker MK, Jentink J, Vroom F, et al. Drug prescription patterns before, during and after pregnancy for chronic, occasional and pregnancy-related drugs in the Netherlands. BJOG 2006; 113: 559–68
Engeland A, Bramness JG, Kjersti Daltveit A, et al. Prescription drug use among fathers and mothers before and during pregnancy: a population-based cohort study of 106 000 pregnancies in Norway 2004–2006. Br J Clin Pharmacol 2008; 65: 653–60
Splinter MY, Sagraves R, Nightengale B, et al. Prenatal use of medications by women giving use at a university hospital. South Med J 1997; 90: 498–502
Egen-Lappe V, Hasford J. Drug prescription in pregnancy: analysis of a large statutory sickness fund population. Eur J Clin Pharmacol 2004; 60: 659–66
Nordeng H, Eskild A, Nesheim BI, et al. Drug use during early pregnancy. Eur J Clin Pharmacol 2001; 57: 259–63
De Vigan C, De Walle HEK, Cordier S, et al. Therapeutic drug use during pregnancy: a comparison in four European countries. J Clin Epidemiol 1999; 52: 977–82
Wilson RD, Davies G, Desilets V, et al. The use of folic acid for the prevention of neural tube defects and other congenital anomalies. J Obstet Gynaecol Can 2003; 25: 959–73
Werler MM, Mitchell AA, Hernandez-Diaz S, et al., and the National Birth Defects Prevention Study. Use of over-the-counter medications during pregnancy. Am J Obstet Gynecol 2005; 193: 771–7
Damase-Michel C, Lapeyre-Mestre M, Moly C, et al. Drug use during pregnancy: survey in 250 women consulting at a university hospital center [in French]. J Gynecol Obstet Biol Report 2000; 29: 77–85
Acknowledgements
No sources of funding were used to assist in the preparation of this study. The authors have no conflicts of interest that are directly relevant to the content of this study.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Autret-Leca, E., Deligne, J., Leve, J. et al. Drug Exposure during the Periconceptional Period. Pediatr-Drugs 13, 317–324 (2011). https://doi.org/10.2165/11591260-000000000-00000
Published:
Issue Date:
DOI: https://doi.org/10.2165/11591260-000000000-00000