Asthma and Pregnancy
.Asthma and Pregnancy by Patricia Carroll (January 2004) raised the important point that uncontrolled asthma can result in serious complications during pregnancy and emphasized the need for women with asthma to continue taking their controller medications. When prescribing controller medications for use during pregnancy, it is necessary to balance the risk of adverse effects with the benefits provided to the mother and fetus.
The author stated that there are no human data on which a risk assessment can be made for the inhaled corticosteroids (ICSs) budesonide, flunisolide, fluticasone, and triamcinolone. This is incorrect, as Swedish birth-registry data from 2,014 infants whose mothers used inhaled budesonide during early pregnancy have been reported.1 The rate of congenital malformations associated with maternal budesonide use (3.8%) was similar to that reported for the general population (3.5%).1 A subsequent analysis2 of birth-registry data that included an additional 520 infants reported a 3.6% rate of congenital malformations for infants of women using budesonide during pregnancy and for the general population. Based on these data, the US Food and Drug Administration (FDA) upgraded a budesonide dry-powder inhaler from Pregnancy Category C to B in December 2001. In January 2003, these data were again cited as the basis for upgrading a budesonide inhalation suspension indicated for use in children aged 12 months to 8 years to Category B.
Agreed, there are limitations in the current FDA pregnancy labeling system. Although detailed information on fertility, pregnancy, and breastfeeding might be preferable, we disagree with the authors statement that the simple A-B-C-D-X system now in use is of little value in clinical practice. A recent survey3,4 suggests that physicians agree. Although only 30% of obstetricians and gynecologists surveyed were aware that an ICS had recently been upgraded to Category B,3 these physicians indicated that being informed of the rating would be likely to affect their future prescribing.4
Current National Asthma Education and Prevention Program (NAEPP) guidelines recommend ICSs as the cornerstone of therapy for persistent asthma.5 Because some physicians might be reluctant to prescribe ICS therapy for pregnant women, it is important to alert them to the availability of a Category B ICS. The 2000 position statement6 of the American College of Obstetricians and Gynecologists and the American College of Allergy, Asthma & Immunology recommends cromolyn, rated Category B but recognized as less effective than ICSs, as first-line therapy for pregnant women with mild asthma. The NAEPPs new recommendations,7,8 based on 44 articles published from 1990 through mid 2003, call for an as-needed, short-acting b2-adrenergic agonist, particularly albuterol, for treatment of mild intermittent asthma and all persistent asthma. A low-dose ICS is now recommended for treatment of mild persistent asthma during pregnancy, whereas cromolyn is now considered an alternative treatment. For moderate and severe persistent asthma, ICSs are still recommended. A low-dose ICS and a long-acting b2-adrenergic agonist (LABA), or a medium-dose ICS, are the preferred options for treatment of moderate persistent asthma during pregnancy. A high-dose ICS and a LABA, particularly salmeterol, are the preferred treatment for pregnant women with severe persistent asthma. The NAEPP notes that there are more data available for budesonide. Physicians adhering to national recommendations now have the option of prescribing a Category B ICS (budesonide) as a first-line drug to pregnant women with persistent asthma.
Paul A. Gluck, MD
Department of Obstetrics and Gynecology
University of Miami School of Medicine
Joan Gluck, MD
Florida Center for Allergy & Asthma Care
Patricia Carroll was shown this letter and declined to comment.
1. Källén B, Rydhstroem H, Åberg A. Congenital malformations after the use of inhaled budesonide in early pregnancy. Obstet Gynecol. 1999;93:392-395.
2. Ericson A, Källén B. Use of drugs during pregnancy: unique Swedish registration method that can be improved. Information From the Swedish Medical Products Agency. 1999;1:8-11.
3. Ostrom NK, Cruz-Rivera M. Prescription patterns among obstetrics and gynecology physicians (Ob/Gyns) for pregnant and nonpregnant asthmatic patients. Ann Allergy Asthma Immunol. 2003;90:144.
4. Gluck PA, Ostrom NK, Park P. Impact of FDA pregnancy category ratings on obstetrician and gynecologist prescribing for asthma. Obstet Gynecol. 2003;101:110S.
5. National Asthma Education and Prevention Program. Expert panel report: guidelines for the diagnosis and management of asthmaupdate on selected topics 2002. J Allergy Clin Immunol. 2002;110:S141-S219.
6. American College of Obstetricians and Gynecologists, American College of Allergy, Asthma and Immunology. Position statement. The use of newer asthma and allergy medications during pregnancy. Ann Allergy Asthma Immunol. 2000;84:475-480.
7. Schorr M. New guidelines for pregnant asthmatics. Available at: http://www.medscape.com/viewarticle/472336. Accessed May 7, 2004.
8. National Asthma Education and Prevention Program. Quick Reference. NAEPP Expert Panel Report. Managing Asthma During Pregnancy: Recommendations for Pharmacologic TreatmentUpdate 2004. Bethesda, Md: US DHHS; 2004.