Outcome of pregnancy in a randomized controlled study of patients with asthma exposed to budesonide

Annals of Allergy, Asthma and Immunology

Volumn 95, Issue 6, 2005, Pages 566-570

  Silverman, Michael ^a   Sheffer, Albert ^b   Diaz, Patricia V ^c   Lindmark, Bertil ^d   Radner, Finn ^d   Broddene, Maria ^d   Gerhardsson De Verdier, Maria ^d,e   Pedersen, Søren ^f   Pauwels, Romain A ^g  

^a UNIVERSITY OF LEICESTER   (United Kingdom)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c UNIVERSITY OF CHILE   (Chile)

^d ASTRAZENECA R AND D   (Sweden)

^e LUND UNIVERSITY HOSPITAL   (Sweden)

^f KOLDING HOSPITAL   (Denmark)

^g GHENT UNIVERSITY HOSPITAL   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

BUDESONIDE; CORTICOSTEROID;

ADOLESCENT; ADULT; AGED; ARTICLE; ASTHMA; CLINICAL TRIAL; CONGENITAL MALFORMATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DOUBLE BLIND PROCEDURE; DRY POWDER; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MATERNAL DISEASE; MULTICENTER STUDY; PREGNANCY OUTCOME; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SPONTANEOUS ABORTION;

EID: 29444451842     PISSN: 10811206     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1081-1206(10)61020-4     Document Type: Article

References (28)

1. National Institutes of Health, National Heart, Lung, and Blood Institute. National Asthma Education Program Report of the Working Group on Asthma and Pregnancy. Bethesda, MD: National Institutes of Health; 1993. Publication No. 93-3279A.
2. Dombrowski MP. Pharmacologic therapy of asthma during pregnancy. Obstet Gynecol Clin North Am. 1997;24:559-574.
3. Schatz M. Interrelationships between asthma and pregnancy: a literature review. J Allergy Clin Immunol. 1999;103:8330-8336.
4. Jana N, Vasishta K, Saha SC, Khunnu B. Effect of bronchial asthma on the course of pregnancy, labour and perinatal outcome. J Obstet Gynaecol. 1995;21:227-232.
5. Schatz M, Zeiger RS, Hoffman CP, et al. Perinatal outcomes in the pregnancies of asthmatic women: a prospective controlled analysis. Am J Respir Crit Care Med. 1995;151:1170-1174.
6. Stenius-Aarniala B, Riikonen S, Teramo K. Slow-release theophylline in pregnant asthmatics. Chest. 1995;107:642-647.
7. American College of Obstetricians and Gynecologists (ACOG) and the American College of Allergy, Asthma and Immunology (ACAAI). The use of newer asthma and allergy medications during pregnancy. Ann Allergy Asthma Immunol. 2000;84:475-480.
8. Baxter H, Fraser FC. Production of congenital defects in offspring of female mice treated with cortisone. McGill Med J. 1950;19:245-249.
9. Walker E. Cleft palate produced in mice by human-equivalent dosage with triamcinolone. Science. 1965;149:862-863.
10. Reinisch JM, Simon NG, Karow WG, Gandelman R. Prenatal exposure to prednisone in humans and animals retards intrauterine growth. Science. 1978;202:436-438.
11. Fraser DC, Sajoo A. Teratogenic potential of corticosteroids in humans. Teratology. 1995;51:45-46.
12. Queisser-Luft A, Eggers I, Stolz G, et al. Serial examination of 20,248 newborn fetuses and infants: correlations between drug exposure and major malformations. Am J Med Genet. 1996;63:268-276.
13. Rodriquez-Pinilla E, Martinez-Frias LM. Corticosteroids during pregnancy and oral clefts: a case-control study. Teratology. 1998;58:2-5.
14. Carmichael SL, Shaw GM. Maternal corticosteroid use and risk of selected congenital anomalies. Am J Med Genet. 1999;86:242-244.
15. Park-Wyllie L, Mazzotta P, Pastuszak A, et al. Birth defects after maternal exposure to corticosteroids: prospective cohort study and meta-analysis of epidemiological studies. Teratology. 2000;62:385-392.
16. Schardein JL, ed. Chemically Induced Birth Defects. 3rd ed. New York, NY: Marcel Dekker; 2001:322-330.
17. Källén B, Rydhstroem H, Åberg A. Congenital malformations after the use of inhaled budesonide in early pregnancy. Obstet Gynecol. 1999;93:392-395.
18. Ericson A, Källén B. Use of Drugs During Pregnancy: Unique Swedish Registration Method That Can Be Improved. Vol 1. Uppsala: Swedish Medical Products Agency; 1999:8-11.
19. Norjavaara E, Gerhardsson de Verdier M. Normal pregnancy outcomes in a population-based study including 2968 pregnant women exposed to budesonide. J Allergy Clin Immunol. 2003;111:736-742.
20. Supplemental New Drug Application for changes to the pregnancy subsection of the precautions section related to a change in the pregnancy category for Pulmicort Turbuhaler® from "C" to "B" FDA2001. Available at: http://www.fda.gov/cder/foi/appletter/2001/20441s12ltr.pdf.
21. Namazy J, Schatz M, Long L, Lipkowitz M, Lillie MA, Voss M. Use of inhaled steroids by pregnant asthmatic women does not reduce intrauterine growth. J Allergy Clin Immunol. 2004;113:427-432.
22. Pauwels RA, Pedersen S, Busse WW, et al. Early intervention with budesonide in mild persistent asthma: a randomised doubled-blind trial. Lancet. 2003;361:1071-1076.
23. Mastroianni AC, Faden R, Federman D, eds. Risks to reproduction and offspring. In: Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Trials. Vol 1. Washington, DC: National Academies Press; 1994:175-202.
24. Jadad AR, Sigouin C, Mohide PT, Levine M, Fuentes M. Risk of congenital malformations associated with treatment of asthma during early pregnancy [letter]. Lancet. 2000;355:119.
25. Schatz M, Zeiger RS, Harden K, et al. The safety of asthma and allergy medication during pregnancy. J Allergy Clin Immunol. 1997;100:301-306.
26. Lipworth BJ. Systemic adverse effects of inhaled corticosteroid therapy: a systematic review and meta-analysis. Arch Intern Med. 1999;159:941-945.
27. Lipworth BJ, Jackson CM. Safety of inhaled and intranasal corticosteroids: lessons for the new millennium. Drug Saf. 2000;23:11-33.
28. Aushus RJ, Miller WL. The principles, pathways, and enzymes of human steroidogenesis. In: DeGroot LJ, Jamesson JR, eds. Endocrinology. 4th ed. Philadelphia, PA: WB Saunders Co; 2001:1616-1631.